Pierluigi Porcu, MD, director, Medical Oncology and Hematopoietic Stem Cell Transplantation and coleader, Immune Cell Regulation and Targeting Program, Sidney Kimmel Cancer Center, at Jefferson Health in Philadelphia, PA, explained how the combination of brentuximab vedotin plus chemotherapy works in in frontline Hodgkin lymphoma.

Targeted OncologyTM: Following a diagnosis of classical Hodgkin lymphoma, nodular sclerosis type, what additional molecular testing should be ordered?

PORCU: PD-1 and PD-L1; I think most hematopathology labs nowadays run PD-1 and PD-L1 on Hodgkin [lymphoma] cases. Certainly, most hematopathology labs run CD30, although they may not run it on non-Hodgkin lymphoma cases on a routine basis.

Barr virus [EBV]. Its an in situ hybridization test thats fairly routine and not very expensive. It identifies cases of Hodgkin lymphoma that are EBV positive. Its important because there are some pretty good data that [show] EBV identifies a subgroup of Hodgkin lymphoma that has an inferior prognosis in terms of progression-free survival [PFS]. [Its also important because] there are now treatments for relapsed patients who have EBV-positive lymphoma including Hodgkin.

In some cases, the diagnosis is complex. You may have a gray-zone lymphoma or primary mediastinal B-cell lymphoma, [so its important] to have additional markers more in the space of diffuse large B-cell lymphoma to make sure.

In very difficult cases, the other testing would be immunoglobulin heavy chain gene rearrangement. This is routinely negative in Hodgkin lymphoma because the immunoglobulin in genes is aberrantly rearranged and mutated.

Why is PD-1 testing needed for diagnosis?

It doesnt affect diagnosis. Its part of the characterization of the Hodgkin lymphoma as a whole. I use it as a routine initial assessment because you never know when patients come back to have a second biopsy how easy it [will be] to get the tissue the second time around.

Can you discuss the International Prognostic Score [IPS]?

The IPS, [also called the Hasenclever index], was published in 1998 and is specifically for advanced-stage serum albumin level of less than 4; a hemoglobin level of less than 10.5; male sex; age equal to or older than 45; stage IV disease; and total WBC count of more than 15,000 or a lymphocyte count of less than 600, less than 8% of the WBC count, or both.1 The patient here has a number of these items. She has a hemoglobin of 9.5, stage IV disease, a WBC count higher than 15,000, and a lymphocyte count less than 600. Her IPS is 4. Based on the data from Hasenclever, her 5-year overall survival [OS] rate is 61%. Interestingly enough, [British Columbia Cancer] looked at their data in terms of the Hasenclever classes and found that for the patients with the highest scores, over time, some of these 5-year survivals were better, but not for the lower ones.

In addition, even though the lymphocyte count is part of the canonical standard, lymphopenia is a common phenomenon in most lymphomas. I follow it closely in T-cell lymphomas, where its common for people to have lymphocyte counts less than 500 and certainly less than 250 in AIDS territory, even though they dont have a history of opportunistic infection. I think the lymphocyte count is clearly an important biological flag marker, although we dont quite know what the biology of that is.

What are your thoughts on the options provided in the poll and the results?

Essentially here, were talking about SWOG S0816 [NCT00822120] or the RATHL [NCT00678327] clinical trial [regimens]. Straight-up escalated BEACOPP [bleomycin, etoposide, doxorubicin (Adriamycin), cyclophosphamide, vincristine (Oncovin), procarbazine, prednisone] German style, brentuximab vedotin [BV; Adcetris] with AVD [doxorubicin, vinblastine, dacarbazine] according to the ECHELON-1 [NCT01712490] trial, or other.

There were 4 votes for PET-adapted therapy with ABVD [doxorubicin, bleomycin, vinblastine, dacarbazine]. We have 7 who voted for BV plus AVD. No votes for escalated BEACOPP, which, even though its perfectly appropriate, Im happy to see [no votes for] because Im not a fan of escalated BEACOPP, and no [votes for] other. The majority would vote for the ECHELON-1 approach for this particular patient.

What frontline systemic therapy are you most likely to recommend for this patient?

Theres no role for radiation therapy. I think the jury is still out regarding PET-adapted therapy versus nonPET-adapted therapy. When I approach patients with advanced-stage disease, I look at a couple of things. One is, which risk category do they really belong to? The other is that PET-adapted therapy is dependent on the PET [scan]. Good-quality reading of PET scans is far from common; they dont give you Deauville [score]. Its unclear how they reach their conclusion because they dont compare the mediastinal and liver to the hypermetabolic lymph nodes. Its not that easy to get a good highquality PET interpretation, and if youre making these big decisions about the escalationor rather, in my case, deescalation according to the RATHL trialthen not having a goodquality PET is a big problem.

One of the big things about frontline therapy is that now we try to avoid exposure to bleomycin. There are 2 ways of doing that: Pick BV and AVD or treat the patient according to RATHL. Thats if the PET is negative; then you can deescalate and remove the bleomycin from the last 4 cycles of ABVD.2

Which factors do you think are most important?

It looks like everyone is on the same page as far as lung function and lung issues [if] someone is a heavy smoker or has a previous history of lung disease. Its not common in young people but certainly more common in middleaged or older people. Then, obviously, the selection of the therapy is important. The BV plus AVD had less lung toxicity compared to AVD, but its not that they had no lung toxicity. You still have to be worried somewhat and monitor people carefully on this therapy, even if it doesnt have bleomycin. Then for the PET-adapted ABVD, like RATHL, the first 2 cycles still contain bleomycin. Certainly, that is fundamental.

Here we have lung disease, prognostic score, performance. Age is really, in my practice, an important part of the decision-making because its not very common. Patients who are older than 60 or 65 generally represent no more than 20% of the cases of Hodgkin lymphoma. But when you have those patientsIm sure you all have seen them in your practicetheir prognosis is particularly bad, especially for those who are older than 70. Selecting the proper therapy for those patients is difficult and, of course, there are trials currently going on. Some of them have been published. For example, BV and bendamustine is one option. There are also trials with single-agent BV ongoing for patients who are frail on the front line. Besides, of course, all the combinations with checkpoint inhibitors...Theres quite a bit going on. For me, age is a very important component of decision-making.

Can you discuss the findings of the ECHELON-1 trial?

Following the initial phase 1 trial, data from ECHELON-1 showed that you cant give BV with ABVD because of a high rate of pulmonary toxicity. Finding the right dose of BV [is important] because it has to be given every 2 weeks. There are several dose-escalation records in phase 1, but 1.2 mg/kg was found to be the right tolerable dose for this schedule.

This was a large study of 1334 patients who were randomized 1:1 to receive 6 cycles of ABVD or 6 cycles of BV plus AVD. There was an interim PET scan, mostly to assess the response but not to be acted on, except for Deauville 5. [Those participants] would be given the opportunity to receive alternative therapy, and this was not part of the modified PFS scoring. Then there was an end of therapy CT-PET scan. Standard follow-up inclusion criteria [included] classical Hodgkin lymphoma that was stage III and IV, up to an ECOG performance status of 2, more than 18 years old, measurable disease, and adequate organ function. The primary end point was modified PFS, and a key secondary end point was OS.3

The initial paper was published in the New England Journal of Medicine in early 2018 with 2-year PFS data.3 But follow-up data [presented during the 2020 American Society of Hematology Annual Meeting and Exposition] show a median follow-up of 55.6 months with PFS of 82% [95% CI, 78.7%-84.8%] for BV plus AVD versus 75.2% [95% CI, 71.5%-78.4%] for ABVD. There is an advantage in terms of PFS.4 OS was no different between the 2 cohorts.

Not all the subgroups had a clear advantage, but younger patients, less than 45, and patients with the highest IPS did. There was an odd distinction: The North American cases appeared to have a stronger benefit compared with the European cases. I dont think anyone has a good explanation for that at this point. In addition, male sex and good performance status seem to be falling on the side of the fence that has a greater gain from BV plus AVD.5

In terms of adverse events [AEs], peripheral neuropathy was more common in the BV plus AVD group compared with the ABVD group [67% vs 43%, respectively]. There were also some gastrointestinal AEs, [including diarrhea (27% vs 18%, respectively) and abdominal pain (21% vs 10%)]. Overall, the 2 cohorts were fairly comparable in terms of overall AEs, except for...a greater number of hospitalizations and infections in the BV plus AVD cohort, which then led to the amendment toward the end of enrollment.3

Key toxicities are pulmonary toxicity and infections and neutropenia. Pulmonary toxicity was seen in both the BV plus AVD and ABVD cohorts, but ABVD had a significantly greater rate of pulmonary toxicity. In terms of on-study death, there were 9 deaths on the BV plus AVD cohort, and of those, 7 were from neutropenia or neutropenic infection. On the other hand, there were 13 deaths on the ABVD cohort, and the majority of them were because of pulmonary toxicity.3

Was the peripheral neuropathy reversible?

Eighty-four percent in the BV plus AVD cohort and 86% in the AVBD cohort reported complete resolution of peripheral neuropathy at almost 5 years. The median to improvement was 30 weeks for BV plus AVD and 16 weeks for AVBD, and then there was a subset that had ongoing neuropathy, mostly grades 1 and grade 2.4

In terms of survivorship, what guidance do you offer patients?

We still dont know much about safety from the standpoint of fertility. In this study, there were a good number of pregnancies and deliveries with healthy babies in women who participated.

Historically, there is a large body of data showing that the impact of ABVD, particularly 6 cycles of ABVD, is trivial to minimal in terms of fertility. Therefore, for patients treated with ABVD, I only [recommend] fertility consultation if the patient or the spouse has a significant degree of anxiousness about it. The other thing I always tell patients about fertilityand this is true for any diseaseis that its impossible to figure out what your fertility is if you never had kids. If someone had children already, then you know that their baseline fertility is standard or average. Its there. If they never did, then its impossible to say what it will be following treatment with anything.

We also dont know what the impact is going to be on second-line efficacy. BV is not going to be a weapon in your toolbox when people progress after BV plus AVD. I think that these are the big questions that we have that require long-term followup. Im selective with the patients that I treat with BV plus AVD. Certainly, for the younger patients, less than age 45, and patients who have advanced stage or high IPS scores, I tend to use this frontline approach. For the others, Im less enthusiastic about using it. I think the financial cost is worth it in those subgroups, including the risk to some degree, but it may not be in the others.

Is progressive multifocal leukoencephalopathy [PML] a concern?

Yes, there is some concern. Im very familiar with the PML cases that were diagnosed in patients who were treated with BV as a single agent with T-cell lymphoma. This is something that I mention to patients as a possible long-term, very severe risk, just like you have the same [risk] when you give Rituxan [rituximab]. I think there should be a concern, but its a minimal concern for this population based on the data that we have.

REFERENCES:

1. Hasenclever D, Diehl V. A prognostic score for advanced Hodgkins disease. International Prognostic Factors Project on advanced Hodgkins disease. N Engl J Med. 1998;339(21):1506-1514. doi:10.1056/NEJM199811193392104

2. NCCN. Clinical Practice Guidelines in Oncology. Hodgkin lymphoma, version 2.2021. Accessed February 1, 2021. https://bit.ly/3oDAEZ4

3. Connors JM, Jurczak W, Straus DJ, et al; ECHELON-1 Study Group. Brentuximab vedotin with chemotherapy for stage III or IV Hodgkins lymphoma. N Engl J Med. 2018;378(4):331-344. doi:10.1056/NEJMoa1708984

4. Straus DJ, Dugosz-Danecka M, Connors J, et al. Brentuximab vedotin with chemotherapy for patients with previously untreated, stage III/IV classical Hodgkin lymphoma: 5-year update of the ECHELON-1 study. Presented at: 62nd American Society of Hematology Annual Meeting and Exposition; December 5-8, 2020; virtual. Accessed February 4, 2021. https://bit.ly/3pKKnx7

5. Straus DJ, Dugosz-Danecka M, Alekseev S, et al. Brentuximab vedotin with chemotherapy for stage III/IV classical Hodgkin lymphoma: 3-year update of the ECHELON-1 study. Blood. 2020;135(10):735-742. doi:10.1182/ blood.2019003127

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Brentuximab Vedotin Plus Chemotherapy Works as a Primary Option for Hodgkin Lymphoma - Targeted Oncology

Pet stem cell therapy is a process that has been used successfully on cats, dogs, and even horses. It is a branch of regenerative medicine that involves the treatment of bone and ligament injuries and osteoarthritis. And it can significantly improve your pets quality of life. Heres what you need to know about regenerative stem cell therapy in Texas.

Stem cells refer to undifferentiated cells whose daughter cells may easily differentiate into other cell types. This includes nerve, muscle, cartilage, fat, bone, liver, etc. They are used extensively in regenerative stem cell therapy.

Stem cells occur naturally in the body and are generally drawn to damaged areas. They swing into action by swiftly repairing the damaged tissue. In-depth studies show that stem cells contribute immensely to the repair of damaged bone tissue and cartilage. And they are known to assist in decreasing inflammation, preventing additional cell deterioration, minimizing pain, and promoting active tissue regeneration.

Pet stem cell therapy begins with the collection of cells or mesenchymal stromal from the bone marrow in the animals femur. They can also be taken from blood plasma.

These cells are then isolated and concentrated via a specializing system. as soon as this process is complete, the stem cells can be injected into affected joints or damaged tissue to promote the healing process.

There are presently no comprehensive studies that fully support the fact that pet stem cell therapy works. Several stories from pet owners or veterinarians prove that it works. Research is still ongoing to determine the efficacy of this procedure on pets.

But one profound benefit of regenerative stem cell therapy is that there are little or zero risks of rejection or reaction. This is because the stem cells are harvested from your pet. This means that the inflamed or damaged area will heal up faster as it quickly develops the characteristics of cells required to repair a pets injuries.

Stem cells can also jumpstart the healing process by activating nearby cells and even recruiting additional ones for tissue repair.

Any injured petcats, dogs, horses, etc.can benefit immensely from regenerative stem cell therapy. Therefore, if your canine or feline has arthritic joints or damaged tissue, pet stem cell therapy may be a viable option.

Other benefits of stem cell therapy include:

Clinical trials have shown that this medical approach can be adopted for injuries linked to the spinal cord. However, there is little concrete evidence that shows that stem cell therapy works as expected.

If your dog or pet has damaged tissue or joint or suffers from osteoarthritis, undergoing regenerative stem cell therapy is an ideal option.

Go here to learn more about stem cell therapy and taking your pet to a reliable stem cell therapy clinic in Texas.

Link:
What are the Benefits of Regenerative Stem Cell Therapy ...

Early results from a phase 2 trial (NCT03019640) showed that cord bloodderived natural killer (NK) immunotherapy plus high-dose chemotherapy and autologous stem cell transplant (ASCT) induced early antitumor response in B-cell non-Hodgkin lymphoma (NHL).

The trial investigators evaluated the potential of the novel cellular cord bloodderived NK immunotherapy in patients with B-cell NHL who are undergoing high-dose chemotherapy and ASCT and presented their findings in a poster at the recent 2021 Transplant & Cellular Therapy Meetings. They chose CB units for NK cell expansion on artificial antigen presenting cells and without human leukocyte antigens (HLA) matching to provide increased expansion and make the treatment off-the-shelf capable.

The study enrolled patients who were aged 15 to 70 with B-cell NHL, excluding primary central nervous system lymphoma, who were candidates for high-dose chemotherapy and ASCT. Patients were required to have adequate end-organ function, an ECOG performance status of 0 or 1, and prior apheresis of 2 x 106 CD34+ cells/Kg in order to be eligible.

Those with prior whole brain irradiation, active hepatitis B, evidence of cirrhosis or high-grade liver fibrosis, active infection, HIV infection, or received radiation therapy within the past month were excluded from joining the trial.

Patients were given intravenous (IV) carmustine over 2 hours 12 days prior to transplant, IV etoposide twice daily over 3 hours and IV cytarabine twice daily over 1 hour for days 11 to 8 prior to transplant, IV melphalan over 30 minutes 7 days prior to transplant, oral lenalidomide (Revlimid) once daily for days 7 through 2 prior to transplant. Additionally, patients who are CD20-positive received IV rituximab (Rituxan) over 3 hours for days 13 through 7 prior to transplant.

Then patients received cord bloodderived expanded allogeneic NK cells intravenously over 1 hour on day 5 prior to ASCT. Five days following ASCT, patients started received daily subcutaneous filgrastim.

The primary end point was 30-day treatment-related mortality (TRM) and secondary end points were relapse-free survival (RFS), overall survival, and NK cell persistence.

Study authors, led by Yago L. Nieto, MD, PhD, in the Department of Stem Cell Transplantation, Division of Internal Medicine, The University of Texas MD Anderson Cancer Center in Houston, provided an update on data for 20 of the enrolled patients in the study. Patients were enrolled between December 2017 and July 2020. One patient experienced rapid tumor progression during culture of NK cells and thus was not treated in the study.

The median age of the 19 treated patients was 60 years (range, 33-70) with the majority (73.7%) being male and having diffuse large B-cell lymphoma (DLBCL; 84.2%); the 3 remaining patients had mantle cell lymphoma (n = 2) or follicular lymphoma (n = 1). More than two-thirds (68.4%) of patients had relapsed disease whereas the 2 patients with MCL were being treated in the frontline setting and 4 patients had primary refractory disease. The median number of prior lines of therapy was 2 (range, 1-4).

Response assessed through PET at ASCT was a complete response for 78.9%, partial response for 15.8%, and progressive disease for 5.3%. Nine patients had 1/6 HLA match of cord blood at DR, 6 had 1/6 match at B, 3 had 1/6 match at A, and 1 had 2/6 match at B and DR.

Cord bloodderived NK cells were expanded a median of 1552-fold (range, 317-4767) with the infused NK product comprising a CD3-CD16+CD56+ phenotype for a median of 98.9% (range, 97.6%-99.5%) of the cells. The cord bloodderived NK cells had a median viability of 96.5% (range, 92%-98%). In the peripheral blood, NK cells were detectable for a mean of 2 weeks (range, 2-3).

For weeks 1 through 3, the cord bloodderived NK cells showed a higher percentage of NKG2D and NKp30 activation receptors than the patients own NK cells; the study authors noted that this indicated an effector phenotype. Additionally, NK persistence was found not to be impacted by the degree of HLA mismatch.

At a median follow-up of 18 months (range, 4-340), the RFS rate was 68% and the OS rate was 84%. Eleven of the 16 patients (68.8%) with DLBCL are still in remission.

The study authors concluded that expanded and highly purified cord bloodderived NK immunotherapy was safe and promising in combination with high-dose chemotherapy and ASCT in patients with B-cell NHL.

Reference:

Nato Y, Kaur I, Hosing C, et al. Immunotherapy with ex vivo-expanded cord blood (CB)-derived nk cells combined with high-dose chemotherapy (HDC) and autologous stem cell transplant (ASCT) for B-cell non-hodgkins lymphoma (NHL). Presented at: 2021 Transplant & Cellular Therapy Meetings; February 8-12, 2021; Virtual. LBA15.

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In B-Cell NHL, Off-the-Shelf NK Immunotherapy Shows Promise When Used With Chemotherapy and ASCT - Cancer Network

The global China Mesenchymal Stem Cells Market report by BMRC provides a detailed analysis of the area marketplace expanding; competitive landscape; global, regional, and country-level market size; market growth analysis; market share; opportunities analysis; product launches; recent developments; sales analysis; segmentation growth; technological innovations; and value chain optimization. The report offers a comprehensive list of key players, their strategies they adopt to sustain in the market. All of this and more information is covered in 200 pages.

The Coronavirus (COVID-19) pandemic has affected every aspect of life worldwide. It has forced various industries to re-evaluate their strategies and adopt new ones to sustain during these trying times. The latest report includes the current COVID-19 impact on the market.

Top Key players Thermo Fisher, Bio-Techne, ATCC, MilliporeSigma, PromoCell GmbH, Genlantis, Celprogen, Cell Applications, Cyagen Biosciences, Axol Bioscience

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The global China Mesenchymal Stem Cells market report is a comprehensive analysis of the current and future analysis, which is based on historic data. This provides the reader with quantified data, enabling them to take well informed business decisions. The report has been written using primary and secondary research. It includes predictive analysis, Porters 5 force analysis, SWOT analysis, and real-time analytics. Several graphs have been provided to support the data and for a clear understanding of various facts and figures.

The report has been divided into product types, application, end-users, and regions. These segments provide accurate calculations and forecasts for sales in terms of volume and value. This analysis can help customers increase their business and to take calculated decisions.

The Global China Mesenchymal Stem Cells Market Report has been Segments into:

On the basis of product, this report displays the production, revenue, price, market share and growth rate of each type, primarily split into Human MSC, Mouse MSC, Rat MSC, Other

On the basis of the end users/applications, this report focuses on the status and outlook for major applications/end users, consumption (sales), market share and growth rate for each application, including Research Institute, Hospital, Others

Global China Mesenchymal Stem Cells Market Size & Share, By Regions and Countries/Sub-regions,

Asia Pacific: China, Japan, India, and Rest of Asia Pacific

Europe: Germany, the UK, France, and Rest of Europe

North America: the US, Mexico, and Canada

Latin America: Brazil and Rest of Latin America

Middle East & Africa: GCC Countries and Rest of Middle East & Africa

Research Objectives

To analyze and forecast the Worldwide China Mesenchymal Stem Cells, in terms of value and volume.

Which segment has the potential to gain the highest market share?

To help decision-makers from a new offer perspective and benchmark existing marketing strategy.

Correlate cost structure historical data with key business segments.

Analyze marketing contribution and customer acquisition by up-selling and cross-selling.

Identifying Influencing factors keeping Worldwide China Mesenchymal Stem Cells Intense, factored with periodic analysis of CR4 & CR8 concentration ratio & HHI Index.

Important Features that are under offering & key highlights of the report:

1) Does the study cover COVID-19 Impact Analysis and its effect on Growth %?

Yes, the overall industry has seen quite a big impact due to slowdown and shutdown in the production line & supply chain. The study covers a separate qualitative chapter on COVID-19 Impact analysis. Additionally, it also provides before and after the scenario of COVID-19 on sales growth & market size estimation to better analyze the exact scenario of the industry.

2) How companies are selected or profiled in the report?

List of some players that are profiled in the report include:

Thermo Fisher, Bio-Techne, ATCC, MilliporeSigma, PromoCell GmbH, Genlantis, Celprogen, Cell Applications, Cyagen Biosciences, Axol Bioscience

Usually, we follow NAICS Industry standards and validate company profile with product mapping to filter relevant Industry players, furthermore the list is sorted to come up with a sample size of at least 50 to 100 companies having greater topline value to get their segment revenue for market estimation.

** List of companies mentioned may vary in the final report subject to Name Change / Merger etc.

3) Can we add or profiled a new company as per our needs?

Yes, we can add or profile a new company as per client need in the report, provided it is available in our coverage list as mentioned in answer to Question 1 and after feasibility run, final confirmation will be provided by the research team checking the constraints related to the difficulty of survey.

4) Can we narrow the available business segments?

Yes, depending upon the data availability and feasibility check by our Research Analyst, a further breakdown in business segments by end-use application or product type can be provided (If applicable) by Revenue Size or Volume*.

China Mesenchymal Stem Cells market segmentation

Type Human MSC, Mouse MSC, Rat MSC, Other

Application Research Institute, Hospital, Others

5) Can a specific country of interest be added? What all regional segmentation covered?

Yes, Country-level splits can be modified in the study as per objectives. Currently, the research report gives special attention and focus on the following regions:

North America [United States, Canada, Mexico], Asia-Pacific [China, India, Japan, South Korea, Australia, Indonesia, Malaysia, Philippines, Thailand, Vietnam], Europe [Germany, France, UK, Italy, Russia, Rest of Europe], South America [Brazil, Argentina, Rest of South America], Middle East & Africa [GCC Countries, Turkey, Egypt, South Africa, Rest of the Middle East & Africa]

** One country of specific interest can be included at no added cost. For inclusion of more regional segment quotes will vary.

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Table of Contents1 Industry Overview of Pet Insurance1.1 Brief Introduction of Pet Insurance1.1.1 Definition of Pet Insurance1.1.2 Development of China Mesenchymal Stem CellsIndustry1.2 Classification of Pet Insurance1.3 Status of China Mesenchymal Stem CellsIndustry1.3.1 Industry Overview of Pet Insurance1.3.2 Global Major Regions Status of Pet Insurance

2 Industry Chain Analysis of Pet Insurance2.1 Supply Chain Relationship Analysis of Pet Insurance2.2 Upstream Major Raw Materials and Price Analysis of Pet Insurance2.3 Downstream Applications of Pet Insurance

3 Manufacturing Technology of Pet Insurance3.1 Development of China Mesenchymal Stem CellsManufacturing Technology3.2 Manufacturing Process Analysis of Pet Insurance3.3 Trends of China Mesenchymal Stem CellsManufacturing Technology

4 Major Manufacturers Analysis of Pet Insurance4.1 Company 14.1.1 Company Profile4.1.2 Product Picture and Specifications4.1.3 Capacity, Production, Price, Cost, Gross and Revenue4.1.4 Contact Information4.2 Company 24.2.1 Company Profile4.2.2 Product Picture and Specifications4.2.3 Capacity, Production, Price, Cost, Gross and Revenue4.2.4 Contact Information4.3 Company 34.3.1 Company Profile4.3.2 Product Picture and Specifications4.3.3 Capacity, Production, Price, Cost, Gross and Revenue4.3.4 Contact Information4.4 Company 44.4.1 Company Profile4.4.2 Product Picture and Specifications4.4.3 Capacity, Production, Price, Cost, Gross and Revenue4.4.4 Contact Information4.5 Company 54.5.1 Company Profile4.5.2 Product Picture and Specifications4.5.3 Capacity, Production, Price, Cost, Gross and Revenue4.5.4 Contact Information4.6 Company 64.6.1 Company Profile4.6.2 Product Picture and Specifications4.6.3 Capacity, Production, Price, Cost, Gross and Revenue4.6.4 Contact Information4.7 Company 74.7.1 Company Profile4.7.2 Product Picture and Specifications4.7.3 Capacity, Production, Price, Cost, Gross and Revenue4.7.4 Contact Information4.8 Company 84.8.1 Company Profile4.8.2 Product Picture and Specifications4.8.3 Capacity, Production, Price, Cost, Gross and Revenue4.8.4 Contact Information4.9 Company 94.9.1 Company Profile4.9.2 Product Picture and Specifications4.9.3 Capacity, Production, Price, Cost, Gross and Revenue4.9.4 Contact Information4.10 Company ten4.10.1 Company Profile4.10.2 Product Picture and Specifications4.10.3 Capacity, Production, Price, Cost, Gross and Revenue4.10.4 Contact Information. . .

5 Global Productions, Revenue and Price Analysis of China Mesenchymal Stem Cellsby Regions, Manufacturers, Types and Applications5.1 Global Production, Revenue of China Mesenchymal Stem Cellsby Regions 2014-20195.2 Global Production, Revenue of China Mesenchymal Stem Cellsby Manufacturers 2014-20195.3 Global Production, Revenue of China Mesenchymal Stem Cellsby Types 2014-20195.4 Global Production, Revenue of China Mesenchymal Stem Cellsby Applications 2014-20195.5 Price Analysis of Global China Mesenchymal Stem Cellsby Regions, Manufacturers, Types and Applications in 2014-2019

6 Global and Major Regions Capacity, Production, Revenue and Growth Rate of China Mesenchymal Stem Cells2014-20196.1 Global Capacity, Production, Price, Cost, Revenue, of China Mesenchymal Stem Cells2014-20196.2 Asia Pacific Capacity, Production, Price, Cost, Revenue, of China Mesenchymal Stem Cells2014-20196.3 Europe Capacity, Production, Price, Cost, Revenue, of China Mesenchymal Stem Cells2014-20196.4 Middle East & Africa Capacity, Production, Price, Cost, Revenue, of China Mesenchymal Stem Cells2014-20196.5 North America Capacity, Production, Price, Cost, Revenue, of China Mesenchymal Stem Cells2014-20196.6 Latin America Capacity, Production, Price, Cost, Revenue, of China Mesenchymal Stem Cells2014-2019

7 Consumption Volumes, Consumption Value, Import, Export and Sale Price Analysis of China Mesenchymal Stem Cellsby Regions7.1 Global Consumption Volume and Consumption Value of China Mesenchymal Stem Cellsby Regions 2014-20197.2 Global Consumption Volume, Consumption Value and Growth Rate of China Mesenchymal Stem Cells2014-20197.3 Asia Pacific Consumption Volume, Consumption Value, Import, Export and Growth Rate of China Mesenchymal Stem Cells2014-20197.4 Europe Consumption Volume, Consumption Value, Import, Export and Growth Rate of China Mesenchymal Stem Cells2014-20197.5 Middle East & Africa Consumption Volume, Consumption Value, Import, Export and Growth Rate of China Mesenchymal Stem Cells2014-20197.6 North America Consumption Volume, Consumption Value, Import, Export and Growth Rate of China Mesenchymal Stem Cells2014-20197.7 Latin America Consumption Volume, Consumption Value, Import, Export and Growth Rate of China Mesenchymal Stem Cells2014-20197.8 Sale Price Analysis of Global China Mesenchymal Stem Cellsby Regions 2014-2019

8 Gross and Gross Margin Analysis of Pet Insurance8.1 Global Gross and Gross Margin of China Mesenchymal Stem Cellsby Regions 2014-20198.2 Global Gross and Gross Margin of China Mesenchymal Stem Cellsby Manufacturers 2014-20198.3 Global Gross and Gross Margin of China Mesenchymal Stem Cellsby Types 2014-20198.4 Global Gross and Gross Margin of China Mesenchymal Stem Cellsby Applications 2014-2019

9 Marketing Traders or Distributor Analysis of Pet Insurance9.1 Marketing Channels Status of Pet Insurance9.2 Marketing Channels Characteristic of Pet Insurance9.3 Marketing Channels Development Trend of Pet Insurance

10 Global and Chinese Economic Impacts on China Mesenchymal Stem CellsIndustry10.1 Global and Chinese Macroeconomic Environment Analysis10.1.1 Global Macroeconomic Analysis and Outlook10.1.2 Chinese Macroeconomic Analysis and Outlook10.2 Effects to China Mesenchymal Stem CellsIndustry

11 Development Trend Analysis of Pet Insurance11.1 Capacity, Production and Revenue Forecast of China Mesenchymal Stem Cellsby Regions, Types and Applications11.1.1 Global Capacity, Production and Revenue of China Mesenchymal Stem Cellsby Regions 2019-202411.1.2 Global and Major Regions Capacity, Production, Revenue and Growth Rate of China Mesenchymal Stem Cells2019-202411.1.3 Global Capacity, Production and Revenue of China Mesenchymal Stem Cellsby Types 2019-202411.2 Consumption Volume and Consumption Value Forecast of China Mesenchymal Stem Cellsby Regions11.2.1 Global Consumption Volume and Consumption Value of China Mesenchymal Stem Cellsby Regions 2019-202411.2.2 Global and Major Regions Consumption Volume, Consumption Value and Growth Rate of China Mesenchymal Stem Cells2019-202411.3 Supply, Import, Export and Consumption Forecast of Pet Insurance11.3.1 Supply, Consumption and Gap of China Mesenchymal Stem Cells2019-202411.3.2 Global Capacity, Production, Price, Cost, Revenue, Supply, Import, Export and Consumption of China Mesenchymal Stem Cells2019-202411.3.3 North America Capacity, Production, Price, Cost, Revenue, Supply, Import, Export and Consumption of China Mesenchymal Stem Cells2019-202411.3.4 Europe Capacity, Production, Price, Cost, Revenue, Supply, Import, Export and Consumption of China Mesenchymal Stem Cells2019-202411.3.5 Asia Pacific Capacity, Production, Price, Cost, Revenue, Supply, Import, Export and Consumption of China Mesenchymal Stem Cells2019-202411.3.6 Middle East & Africa Capacity, Production, Price, Cost, Revenue, Supply, Import, Export and Consumption of China Mesenchymal Stem Cells2019-202411.3.7 Latin America Capacity, Production, Price, Cost, Revenue, Supply, Import, Export and Consumption of China Mesenchymal Stem Cells2019-2024

12 Contact information of Pet Insurance12.1 Upstream Major Raw Materials and Equipment Suppliers Analysis of Pet Insurance12.1.1 Major Raw Materials Suppliers with Contact Information Analysis of Pet Insurance12.1.2 Major Equipment Suppliers with Contact Information Analysis of Pet Insurance12.2 Downstream Major Consumers Analysis of Pet Insurance12.3 Major Suppliers of China Mesenchymal Stem Cellswith Contact Information12.4 Supply Chain Relationship Analysis of Pet Insurance

13 New Project Investment Feasibility Analysis of Pet Insurance13.1 New Project SWOT Analysis of Pet Insurance13.2 New Project Investment Feasibility Analysis of Pet Insurance13.2.1 Project Name13.2.2 Investment Budget13.2.3 Project Product Solutions13.2.4 Project Schedule

14 Conclusion of the Global China Mesenchymal Stem CellsIndustry 2019 Market Research Report

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China Mesenchymal Stem Cells Market Share, Growth Factors, Top Manufacturers, By Types, Applications And Forecast To 2027 Express Keeper - Express...

SILVER SPRING, Md., Feb. 8, 2021 /PRNewswire/ -- The following quote is attributed to Steven M. Solomon, D.V.M., M.P.H., director of the FDA's Center for Veterinary Medicine:

Veterinary regenerative medicine is a rapidly growing area of product development that offers great promise in the development of novel therapies for animals. These products, which include animal cell-based therapies such as stem cells, have the potential to repair diseased or damaged tissues in animals through regeneration and healing.

Today, the U.S. Food and Drug Administration is announcing a listing of clinical field studies that are investigating Animal Cells, Tissues, and Cell- and Tissue-Based Products (ACTPs) in veterinary patients. The webpage provides animal owners, veterinarians, researchers and the public with information on clinical field studies that are being investigated for the use of ACTPs in veterinary patients.

We are offering this webpage as a resource because we've heard from veterinarians and pet owners who are eager to take part in clinical studies and avail their patients and pets of the potential that veterinary regenerative medicine may offer. Connecting interested pet owners and their veterinary teams with relevant clinical studies also helps sponsors in generating data toward potential FDA approval.

Generally, the FDA regulates ACTPs as animal drugs if they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease (e.g., osteoarthritis and tendon injuries in animals) in animals, or intended to affect the structure or any function of the body (e.g., improving animal fertility) of animals. The FDA's Center for Veterinary Medicine provides regulatory oversight of clinical field studies for ACTPs, provides veterinary medical researchers with information to address scientific challenges and provides guidance on the regulatory process for their products. We also offer the Veterinary Innovation Program (VIP) to certain sponsors of ACTPs, which helps facilitate advancements in the development of innovative animal products by encouraging development and research, and supporting an efficient and predictable pathway to approval for these products.

Clinical field study information on the webpage includes study name, species, condition, product type, recruitment period, study period, country or state and phone number and/or email address of the sponsor. Clinical field studies evaluating ACTPs are listed on the webpage when the sponsor has provided specific information to the FDA about the study and the sponsor consents to having their study information listed on the webpage. At the time of listing, the information is intended to disclose clinical field studies in support of product development and FDA approval.

Participation is voluntary in clinical field studies for investigational ACTPs, and sponsors must voluntarily consent to having the FDA list their study information on the webpage. The studies listed on the webpage are investigational, and the ACTPs are not FDA-approved. This means the safety and effectiveness of the ACTP is not yet determined. The webpage will be updated with new clinical studies on a quarterly basis, and we expect the list of studies to grow.

We welcome the opportunity to continue working with ACTP sponsors to discuss innovative approaches in developing treatments needed to support safe and effective animal therapies. Our ultimate objective is to obtain interpretable data from well-conducted, well-designed scientific studies. We look forward to working withindividuals, universities and drug companieswho develop this information and to gain a fuller understanding of the potential benefits and risks associated with ACTPs.

As scientists continue to research new and innovative therapies for animal health using animal cells and tissue, we encourage sponsors to develop the data needed to seek potential FDA-approval for their ACTPs. At the same time, we remain committed to taking action as necessary to protect public health against companies that illegally market ACTPs.

Sponsors of ACTPs that are interested in having their clinical trials listed on the FDA's webpage can contact their FDA project manager.

Additional Resources:

Media Contact:Monique Richards, 240-402-3014Veterinary and Consumer Inquiries: [emailprotected]or 800-835-4709

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

SOURCE U.S. Food and Drug Administration

http://www.fda.gov

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FDA Announces New Resource for Veterinarians and Pet ...

Early antitumor activity was seen with cord bloodderived natural killer (NK) immunotherapy in combination with high-dose chemotherapy and autologous stem cell transplant (ASCT) in patients with B-cell non-Hodgkin lymphoma (NHL), according to early results from a phase 2 trial (NCT03019640) presented in a poster during the 2021 Transplant & Cellular Therapy Meetings.

The investigators evaluated the potential of the novel cellular cord bloodderived NK immunotherapy in patients with B-cell NHL who are undergoing high-dose chemotherapy and ASCT. They chose CB units for NK cell expansion on artificial antigen presenting cells and without human leukocyte antigens (HLA) matching to provide increased expansion and make the treatment off-the-shelf capable.

The study enrolled patients who were aged 15 to 70 with B-cell NHL, excluding primary central nervous system lymphoma, who were candidates for high-dose chemotherapy and ASCT. Patients were required to have adequate end-organ function, an ECOG performance status of 0 or 1, and prior apheresis of 2 x 106 CD34+ cells/Kg in order to be eligible.

Those with prior whole brain irradiation, active hepatitis B, evidence of cirrhosis or high-grade liver fibrosis, active infection, HIV infection, or received radiation therapy within the past month were excluded from joining the trial.

Patients were given intravenous (IV) carmustine over 2 hours 12 days prior to transplant, IV etoposide twice daily over 3 hours and IV cytarabine twice daily over 1 hour for days 11 to 8 prior to transplant, IV melphalan over 30 minutes 7 days prior to transplant, oral lenalidomide (Revlimid) once daily for days 7 through 2 prior to transplant. Additionally, patients who are CD20-positive received IV rituximab (Rituxan) over 3 hours for days 13 through 7 prior to transplant.

Then patients received cord bloodderived expanded allogeneic NK cells intravenously over 1 hour on day 5 prior to ASCT. Five days following ASCT, patients started received daily subcutaneous filgrastim.

The primary end point was 30-day treatment-related mortality (TRM) and secondary end points were relapse-free survival (RFS), overall survival, and NK cell persistence.

Study authors, led by Yago L. Nieto, MD, PhD, in the Department of Stem Cell Transplantation, Division of Internal Medicine, The University of Texas MD Anderson Cancer Center in Houston, provided an update on data for 20 of the enrolled patients in the study. Patients were enrolled between December 2017 and July 2020. One patient experienced rapid tumor progression during culture of NK cells and thus was not treated in the study.

The median age of the 19 treated patients was 60 years (range, 33-70) with the majority (73.7%) being male and having diffuse large B-cell lymphoma (DLBCL; 84.2%); the 3 remaining patients had mantle cell lymphoma (n = 2) or follicular lymphoma (n = 1). More than two-thirds (68.4%) of patients had relapsed disease whereas the 2 patients with MCL were being treated in the frontline setting and 4 patients had primary refractory disease. The median number of prior lines of therapy was 2 (range, 1-4).

Response assessed through PET at ASCT was a complete response for 78.9%, partial response for 15.8%, and progressive disease for 5.3%. Nine patients had 1/6 HLA match of cord blood at DR, 6 had 1/6 match at B, 3 had 1/6 match at A, and 1 had 2/6 match at B and DR.

Cord bloodderived NK cells were expanded a median of 1552-fold (range, 317-4767) with the infused NK product comprising a CD3-CD16+CD56+ phenotype for a median of 98.9% (range, 97.6%-99.5%) of the cells. The cord bloodderived NK cells had a median viability of 96.5% (range, 92%-98%). In the peripheral blood, NK cells were detectable for a mean of 2 weeks (range, 2-3).

For weeks 1 through 3, the cord bloodderived NK cells showed a higher percentage of NKG2D and NKp30 activation receptors than the patients own NK cells; the study authors noted that this indicated an effector phenotype. Additionally, NK persistence was found not to be impacted by the degree of HLA mismatch.

At a median follow-up of 18 months (range, 4-340), the RFS rate was 68% and the OS rate was 84%. Eleven of the 16 patients (68.8%) with DLBCL are still in remission.

The study authors concluded that expanded and highly purified cord bloodderived NK immunotherapy was safe and promising in combination with high-dose chemotherapy and ASCT in patients with B-cell NHL.

Reference:

Nato Y, Kaur I, Hosing C, et al. Immunotherapy with ex vivo-expanded cord blood (CB)-derived nk cells combined with high-dose chemotherapy (HDC) and autologous stem cell transplant (ASCT) for B-cell non-hodgkins lymphoma (NHL). Presented at: 2021 Transplant & Cellular Therapy Meetings; February 8-12, 2021; Virtual. LBA15.

Read more from the original source:
Off-the-Shelf NK Immunotherapy Is Safe and Promising in B-Cell NHL With Chemotherapy and Transplant - Targeted Oncology

15 February 2021

MSc Bioethics and Society student, King's College London

The '14-day rule', initially proposed in 1979 in the USA, was first recommended in the UK by the Warnock Committee in 1984. It limits research on intact human embryos to 'prior to 14 days' gestation or the beginning of primitive streak formation' and is part of the Human Fertilisation and Embryology Act 2008.

This legislation has been successfully implemented in the UK, but also in several other countries (eg, Australia's Research Involving Human Embryos Act 2002). It is followed in jurisdictions without relevant laws or even guidelines. While researchers accepted the rule, and have been content to keep to it, many contend that it was simply an arbitrary time limit that was chosen as a compromise to authorise any research at a time when prolife views were strong. While originally it was a barrier that could not be breached for practical reasons, recent research on human and non-human primate embryos suggest that we now have methods to culture intact human embryos beyond 14 days.

I recently argued, in the Journal of Medical Ethics, that the current limit for embryo research should be extended to 28 days to permit research that will further explore our origins as well as potentially provide new therapeutic possibilities to reduce developmental abnormalities and miscarriage.

This conversation is something the Progress Educational Trust (PET), the charity which publishes BioNews, has been advocating for many years. Recent work they have accomplished includes a proposal to the 'My Science Inquiry' launched by the House of Commons Science and Technology Committee. Sandy Starr, deputy director of PET gave oral evidence to the committee advocating for this conversation to be had by government, as it is already an ongoing debate within the scientific community. PET also held their annual conference in 2016, which focused on the 14-day limit on human embryo research, and that featured Baroness Mary Warnock, who was chair of the committee that originally proposed the limit in 1984.

There are a number of reasons why research on embryos between 14 and 28 days, often referred to as the 'black box' period of development, is now ready to be initiated. Several of these are emphasised in my paper.

Firstly, the 'black box' period is when the basic body plan and the formation of critical cell types, tissues, and some organs is initiated. These include germ cells, which are not only essential for the next generation, but are also the early progenitors of the nervous system, blood cells and the heart, and the placenta. It is known that even a subtle defect can have a devastating effect on subsequent development. While we know something about how these develop in model organisms such as the mouse, there are clear differences with human embryos, making it difficult to infer results between species. We also can't yet rely on new stem cell-based models of early human embryos without first carrying out detailed comparisons with the real thing.

It could be argued that 28 days is not long enough. Whilst this is certainly a thought-provoking point, we are already able to obtain embryonic tissues from 28 days and beyond and older fetal tissue to use in scientific research eg, from an aborted fetus. It is also important to consider the need for a 'limit'. If there is not one at all, there is no compromise, discontent, and it could complicate the regulatory system.

In conversations surrounding the 14-day limit there are differing ethical opinions. I argue that in order for those trying for a baby to have legitimate reproductive autonomy, they should have the appropriate assistance and opportunity to produce, at the very least, a healthy child. I also focus on the need to differentiate between 'research' embryos and 'reproductive implanted embryos' ie, the research embryos in question are those whose location will remain in a petri dish.

It is absolutely crucial to outline the importance of a robust regulatory body. In the UK, we are lucky to have the Human Fertilisation and Embryology Authority (HFEA), which means there is government oversight making sure fertility clinics and research centres comply with the law, this extends to human embryo research. For example, in 2016, Dr Kathy Niakan was not just the first person in the UK to be granted a license from the HFEA to use genome editing techniques on human embryos, but the first anywhere to have this type of research sanctioned by a regulatory body. (See BioNews 835).

With any significant legislative change that will directly impact the population, significant public debate must be instigated. Public opinion must be widely surveyed and considered, because any decisions like this should not just be one made by a select few individuals. This can be seen with another significant change in the HFE Act, the addition of mitochondrial donation regulations in 2015, which is an example where public engagement was very important. It gave the Government license to make the changes in the Act, knowing that there was broad support for the use of the methods to avoid mitochondrial disease.

As I conclude in the paper, just because something has once worked does not mean it should stay the same or not strive to be improved. The 14-day limit has become limiting and the conversation around extension must continue.

Go here to read the rest:
The 14-day limit should be extended to 28 days - BioNews

The NCD for Allogeneic Hematopoietic Stem Cell Transplantation (allo HSCT) for the treatment of Myelodysplastic Syndromes (MDS), released by CMS in August 2010, concluded that, absent convincing evidence that allo HSCT improves patient health outcomes, additional research from clinical trials would be appropriate under the Coverage with Evidence Development aspect of CMS coverage authority. The NCD specifies that allo HSCT for the treatment of MDS is covered only when provided to Medicare beneficiaries enrolled in an approved clinical study

Allo HSCT is a procedure in which a portionof a healthy donor's stem cell or bone marrow is obtained and prepared for intravenous infusion. In accordance with the Stem Cell Therapeutic and Research Act of 2005 (US Public Law 109-129) a standard dataset is collected for all allogeneic transplant patients in the United States by the Center for International Blood and Marrow Transplant Research. The elements in this dataset, comprised of two mandatory forms plus one additional form, encompass the information we require for a study under CED.

A prospective clinical study seeking Medicare payment for treating a beneficiary with allogeneic HSCT for MDS pursuant to CED must meet one or more aspects of the following questions:

Potentially, the results of trials may provide sufficient evidence of clinical utility that a future NCD on this topic will provide coverage for such testing for all Medicare beneficiaries.

Decision Memo

Study Title: A Multi-Center Biologic Assignment Trial Comparing Allogeneic Hematopoietic Cell Transplant to Hypomethylating Therapy or Best Supportive Care in Patients w/Intermediate-2 & High Risk Myelodysplastic Syndrome (BMT CTN #1102)Sponsor: Medical College of WisconsinClinicalTrials.gov Number: NCT02016781CMS Approval Date: 12/11/2013

Study Title: Assessment of Allogeneic Hematopoietic Stem Cell Transplantation in Medicare Beneficiaries with Myelodysplastic Syndrome and Related Disorders" - A Sub-study Protocol For A Research Database For Hematopoietic Stem Cell Transplantation, Other Cellular Therapies and Marrow Toxic InjuriesSponsor: Center for International Blood and Marrow Transplant ResearchClincialTrials.gov Number: NCT01166009CMS Approval Date: 12/13/2010

See the original post here:
Allogeneic Hematopoietic Stem Cell Transplant for MDS | CMS

A post-hoc analysis of the practice-changing TRANSCEND NHL 001 trial (NCT02631044) revealed that exposure to anti-CD19 therapy in patients with relapsed/refractory large B-cell lymphoma (LBCL), did not impact response to lisocabtagene maraleucel (liso-cel; Breyanzi).1

Data were presented during the 2021 Transplantation & Cellular Therapy Meeting and showed that among 12 patients who had previously received anti-CD19 therapy, 2 patients achieved a complete response (CR) as their best response to that treatment, 3 patients reported a partial response (PR), and 1 achieved stable disease. Five patients experienced disease progression, while 1 patients response status was unknown.

Results from the analysis showed that 92% (n = 11/12) experienced an objective response to liso-cel per independent review committee (IRC) assessment and Lugano criteria; this included 6 CRs (50%) and 5 PRs with the CAR T-cell therapy. Moreover, 5 patients experienced a duration of response (DOR) to liso-cel of 9 months or longer (range, 0.8-27.4), with 4 patients continuing to respond at the time of data cutoff.

The response rates reported in this subgroup proved to be comparable to those observed in the overall TRANSCEND NHL 001 study population. Of the 256 patients determined to be efficacy evaluable, which included those who were given at least 1 dose of liso-cel and had PET-positive disease per IRC, the objective response rate was 73% (95% CI, 66.8%-78.0%), with a CR rate of 53% (95% CI, 46.8%-59.4%).2 The median DOR had not been reached (95% CI, 8.6not reached [NR]). Moreover, the median progression-free survival (PFS) was 6.8 months in this population (95% CI, 3.3-14.1) and the median overall survival (OS) was 21.1 months (95% CI, 13.3-NR).

In this post-hoc analysis of a small subset of patients from TRANSCEND, patient response to liso-cel and liso-cel pharmacokinetics were not impacted by prior exposure to anti-CD19 therapy, Scott R. Solomon, MD, of the Blood and Marrow Transplant Program, Leukemia and Cellular Immunotherapy Program at the Northside Hospital Cancer Institute, and colleagues, wrote in a poster highlighting the data. Additional analyses on a larger number of patients with prior anti-CD19 therapy are warranted to confirm these findings.

An investigational, CD19-targeted, defined composition, 4-1BB CAR T-cell product, liso-cel is given at equal target doses of CD8 and CD4 T cells; the product has showcased safety and efficacy in patients with aggressive, relapsed/refractory LBCL in the TRANSCEND NHL 001 trial. Data from the trial led to theFebruary 2021 FDA approval of liso-cel for use in adult patients with certain types of large B-cell lymphoma who have not responded to, or who have relapsed after, at least 2 other types of systemic treatment.

The multicenter, pivotal, phase 1 trial enrolled adult patients aged 18 years or older with relapsed/refractory LBCL; this included those with diffuse large B-cell lymphoma (DLBCL); high-grade B-cell lymphoma with rearrangements of MYC and either BCL-2, BCL-6, or both; DLBCL transformed from an indolent lymphoma; primary mediastinal B-cell lymphoma; and follicular lymphoma. To be eligible for enrollment, patients had to have an ECOG performance status of 0-2, creatinine clearance of greater than 30 mL/min/1.73 m2, and a left ventricular ejection fraction of at least 40%.

Those who underwent prior hematopoietic stem cell transplantation and those with secondary central nervous system lymphoma were permitted. Notably, no lower threshold for absolute lymphocyte count, absolute neutrophil count, platelets, or hemoglobin, were established.

In the trial, patients were screened and then underwent leukapheresis where bridging therapy was permitted while the product was being manufactured. Once disease was reconfirmed via PET imaging, patients went on to receive lymphodepleting chemotherapy with fludarabine at 30 mg/m2 and cytarabine at 300 mg/m2, delivered over the course of 3 days. Two to 7 days after the chemotherapy, patients received liso-cel.

A total of 269 participants were assigned to 1 of 3 target dose levels of the CAR T-cell product: 50 106 CAR T cells (1 or 2 doses), 100 106, and 150 106; this was given as a sequential infusion of 2 components, CD8 and CD4 CAR T cells, at equal target doses.

The co-primary end points of the trial included adverse effects (AEs), dose-limiting toxicities, and ORR per Lugano criteria and IRC. Key secondary end points comprised CR rate by IRC, DOR, PFS, OS, and cellular kinetics.

For the post-hoc analysis, investigators looked at a subset of patients from the trial who had previously received CD19-targeted therapy before liso-cel to evaluate impact of the CAR T-cell product on safety and efficacy outcomes, as well as cellular kinetics.

The median age of the 12 patients in the subgroup of interest was 60.5 years, and 83% were male. Half of the patients had an ECOG performance status of 0, while the remainder had a status of 1. The median number of previous lines of treatment was 4. Fifty-eight percent of patients previously underwent transplantation and 67% were refractory to chemotherapy. Regarding histology, 58% had DLBCL not otherwise specified, 33% had DLBCL that was transformed from follicular lymphoma, and 8% had high-grade B-cell lymphoma.

Additional data showed that previous anti-CD19 therapy did not impact cellular kinetic parameters. Liso-cel demonstrated long-term persistence at 3 months in the majority, or 83% (n = 5/6), of those who received prior CD19-targeted treatment; persistence at 1 year was observed in 50% of patients (n = 2/4), which was comparable to those who did not receive previous CD19-targeted treatment.

Regarding safety, all patients in this subgroup experienced treatment-emergent AEs (TEAEs), 58% (n = 7) of which were grade 3 or higher. The most reported grade 3 or higher TEAEs included neutropenia (58%), thrombocytopenia (42%), and anemia (33%). Sixty-seven percent of patients reported all-grade cytokine release syndrome (CRS) and 42% experienced all-grade neurological effects with liso-cel. However, all toxicity rates proved to be comparable to those experienced by the overall study population and all CRS or neurological effects were either grade 1 or 2.

These findings suggest that liso-cel can be considered for the treatment of patients who have received prior anti-CD19 therapies, concluded Solomon.

References:

1. Solomon S, Mehta A, Abramson JS, et al. Experience of prior anti-CD19 therapy in patients with relapsed or refractory large B-cell lymphoma receiving lisocabtagene maraleucel (liso-cel), an investigational anti-CD19 chimeric antigen receptor T cell product. Presented at: 2021 Transplantation & Cellular Therapy Meeting; February 9-13, 2021; Virtual.

2. Abramson JS, Palomba ML, Gordon LI, et al. Lisocabtagene maraleucel for patients with relapsed or refractory large B-cell lymphomas (TRANSCEND NHL 001): a multicentre seamless design study. Lancet. 2020;396(10254):839-852. doi:10.1016/S0140-6736(20)31366-0

Read more here:
Responses to Liso-Cel Not Influenced by Prior Treatment With Anti-CD19 Agents in R/R Large B-Cell Lymphoma - Targeted Oncology

CLEVELAND, Ohio What do you do when someone close to you has cancer?

Sometimes, late at night, I just hug Otto and cry, said Shanna Loede.

Otto is not her husband. Thats Matt Loede, who has been in a battle with lymphoma (a form of blood cancer) for nearly two years.

There have been 25 rounds of chemotherapy. And 25 rounds of radiation. And two stem-cell transplants. And nearly three months spent in the hospital since Matt was first diagnosed in April of 2019.

As if that wasnt enough, Matt recently spent five days in the hospital with COVID-19.

Matt is Shannas husband of eight years. He also has worked for several local sports radio stations, written for a number of sports websites in his 23-year career. He currently writes for the sports website Outkick.

OK, but who is Otto?

Hes the familys mixed terrier, a very huggy dog.

Otto knows to stay close when the sadness and fear try to squeeze the life out of hope and the tears flow with her prayers for her husband.

One piece of advice from Shanna: Its OK to have some nights when you just cry. Having someone (or a pet to hug) really helps.

HOW MUCH WORSE CAN IT GET?

Matts problems began with severe stomach pain and convulsions. Doctors first thought he had pancreatitis. Tests revealed lymphoma that had spread to his stomach and pancreas. At first, the hope was some early treatments would bring it under control.

That turned out to be wrong.

You find out theres a lot you cant control about this type of cancer, said Matt. Its like a tumor in the blood. But its not something they can just go in and cut out.

The Loedes hit what they thought was a low point in early January. A second round of stem cell transplants didnt work. The cancer had spread to his throat.

It was a special treatment, said Shanna. I had read so much about it. There was so much hope. It sounded like the saving grace for lymphoma. I probably overestimated it.

Doctors explained they had run out of the usual treatments.

There is no cure for me, said Matt. I know that hit Shanna hard when she heard the news.

That was one of the worst days. A few weeks later, Matt developed a cough. Then he had a sore throat and headaches.

One of Shannas biggest fears was Id get the virus, he said.

She panicked when taking his temperature. It was 104.

They rushed to University Hospital, where he had been undergoing treatments at the Seidman Cancer Center. Only now, he was in the COVID-19 section of the hospital. It was isolation for five days.

The fever broke within a few hours. But given how Matts body had been ravaged by nearly two years of chemotherapy and radiation, Shanna feared I was going to lose him.

But that didnt happen.

He didnt even need a ventilator, said Shanna. Matt has recovered well. Thats one of the things I tell people in this situation. Count your blessing, look for the miracles.

Shanna is the Director of Training and Development for University Hospitals. In the COVID world, she works from her small upstairs office in their Parma home. Matt is downstairs.

Another blessing, she said. Seidman gives Matthew great care, and Im affiliated with UH. Working from home allows us to be together more.

Shanna and Matt Loede love each other and Snoopy as they work together to fight Matt's blood cancer. Photo by Terry Pluto, cleveland.com.

IT REALLY IS DAY-TO-DAY

Shanna said she is a planner. She is 38, Matt is 45. Under normal circumstances, it would be easy to look way down the highway of life.

I like to think a lot about the future, she explained. Now, it really is day-to-day. Matthew is the love of my life. I try not to think, How long will I have him? Instead, I try to focus on the present. Thats new for me.

The doctors have never told the Loedes Matt has six months to live. But they have been candid about how its a battle to combat the spread. He is now heading into different clinical trials.

Theres not much Shanna can do on the medical front other than be there for her husband.

I cook his favorite food, she said.

Whats that?

Asian meatballs and rice, she said. Matthew is a pretty simple guy. He does like his mothers pierogies, but I cant make them like her.

Shanna raves about her neighbors, who have shoveled snow and brought food over to the house. Their church family from Cleveland Baptist prays for and with them.

There is a couple at church where the husband has had lymphoma for eight years, she said. They are a great help to us...and weve found we can help others going through cancer.

During the Christmas season, you can see Matt and Shanna Loede have lots of visitors. Photo courtesy of Matt Loede.

STRANGE DREAMS

Dreams can be a window to our minds and our fears.

Shanna said twice she had this dream: Matt walks through the door and says, I have six months to live.

But she hasnt had it for a year.

A few times, Matt has dreamed he was watching is own funeral. He saw the casket. He saw lots of people in line to pay their last respects.

I guess it was after the pandemic with all the people there, he said with a laugh.

But Shanna and Matt both said, Going through this makes you very aware of your own mortality.

CLOSER OR FARTHER APART

Matt said he hasnt spent much time on the Why me? question with God. Theres no answer coming. Hes at a place where he knows he has cancer. He is either going through it with God or without God.

If you say you believe and your faith is real, then you have to practice what you preach, said Matt. You dont just quit (with God) when you go though those periods of 12-to-48 hours after chemo where your muscles, your head, everything aches.

Shanna said thats when she feels helpless. Its a time to pray and wait.

I have felt closer to God and to Matthew during all of this, she said.

Matt loves Charlie Brown. Their home is filled with stuffed characters from the Charles Schulz comic strip. Snoopy seems to be everywhere.

At first, (all the stuffed animals) drove me a little crazy, said Shanna. But now, Im accustomed to them. They bring him comfort, and Ill never argue against something bringing him happiness right now.

Good Grief, is Matt like Charlie Brown?

I never thought of until now, she said. But yes. He is loyal, has a BIG heart and is a resilient optimist.

Good Grief! Snoopy & Friends are taking over the Loede household. Photo courtesy of Matt Loede.

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