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Blood cancers have seen tremendous advancements in the past few years due to the dedication of researchers pulling out all the stops to churn out therapeutic innovations intended to be of service to suffering patients. These experimentations and their upshots are always brought to us through various platforms, the American Society of Hematology (ASH 2021) being one of them. On this note, DelveInsight has listed down a few of the major abstracts, including some late breakers from the conference that might help patients as well oncologists choose the best amongst the rest.
Breakthrough results from Phase III POLARIX study in front-line DLBCL
Pivotal POLARIX study by Roche is investigating Polivy (polatuzumab vedotin) in combination with MabThera/Rituxan (rituximab) plus cyclophosphamide, doxorubicin, and prednisone (R-CHP) versus MabThera/Rituxan plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP), in patients with previously untreated diffuse large B-cell lymphoma (DLBCL). Recently in August 2021, the company, in its press release, stated that the Phase III POLARIX trial met its primary endpoint by demonstrating significantly improved and clinically meaningful progression-free survival (PFS). The company has also stated that this Polivy regimen is the first therapy in two decades to improve PFS in DLBCL compared to the standard of care. The full results from the study will be published under the late-breaking abstracts, which might turn up as one of the major groundbreaking data readouts.
Note: Currently, Polivy is used as an off-the-shelf, fixed-duration treatment option in the relapsed or refractory (R/R) DLBCL setting and is approved in combination with bendamustine and MabThera/Rituxan for the treatment of R/R DLBCL in more than 60 countries worldwide, including in the EU and the US.
Yescarta anticipated to amaze with another approval in R/R LBCL post-conference
Gilead is set to present the pioneering data from its pivotal ZUMA-7 study. This study is evaluating the safety and efficacy of Yescarta (axicabtagene ciloleucel) versus thecurrent standard of care for second-line therapy (platinum-based salvage combination chemotherapy regimen followed by high-dose therapy and autologous stem cell transplant in those who respond to salvage chemotherapy) in adult patients with R/R large B-cell lymphoma (LBCL) within 12 months of first-line therapy. The company has recently submitted a supplemental Biologics License Application (sBLA) to the US FDA for Yescartato expand its current indication to include the treatment of adults with R/R LBCL in the second-line setting.
BMS’ CAR-T poses itself as a strong contender against Gilead’s CAR-T in R/R LBCL
Bristol Myers Squibb (BMS) is also going to present the full results from its pivotal TRANSFORM study evaluating Breyanzi (lisocabtagene maraleucel) as a second-line treatment in adults with R/R LBCL compared to salvage therapy followed by high-dose chemotherapy and hematopoietic stem cell transplant, which is currently considered a gold standard treatment for these patients. In June 2021, the company announced the positive topline results from this study and stated that the study met its primary endpoint of demonstrating a clinically meaningful and highly statistically significant improvement in event-free survival (EFS), as well as key secondary endpoints of complete response (CR) rate and PFS compared to standard of care.
Note: Breyanzi was approved by the US FDA in February 2021 for the treatment of adult patients with R/R LBCL after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL)–not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B.
Not a great event for Novartis considering results from Belinda Study
The BELINDA study by Novartis is a pivotal randomized, open-label, multicenter Phase III trial comparing two treatment strategies and assessing the efficacy, safety, and tolerability of Kymriah (tisagenlecleucel) compared to standard-of-care. Patients in the trial had aggressive B-cell non-Hodgkin lymphoma with primary refractory disease or which relapsed within 12 months of first-line treatment. The study proved to be a failure as it could not meet its primary endpoint of EFS compared to treatment with the SOC, as per the latest company press release. The company will present the data under the late-breaking abstracts and mainly focus on trial differences.
The table with some of the key abstracts have been summarized in the table below:
Lymphoma’s Abstracts: ASH 2021 Key Highlights
Multiple Myeloma Abstracts: ASH 2021 Key Highlights
Myelodysplastic Syndromes: ASH 2021 Key Highlights
ASCT: Autologous Stem Cell Transplantation; BCMA: B-cell Maturation Antigen; R-CHOP: rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone; CAR-T: Chimeric Antigen Receptor T-cell; SOC: Standard of Care; R/R: Relapsed/Refractory; AML: Acute Myeloid Leukemia; CMML: Chronic Myelomonocytic Leukemia; DLBCL: Diffuse Large B-Cell Lymphoma; LBCL: Large B-Cell Lymphoma; NHL: Non-Hodgkin Lymphoma; FL: Follicular Lymphoma; MDS: Myelodysplastic Syndromes