Immuno-Oncology Resource Center

Immuno-Oncology Resource Center

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Press Release

June 10, 2021
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CAR-T extends EFS as second-line therapy for advanced B-cell lymphoma, topline data show

Source:

Press Release

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Lisocabtagene maraleucel extended EFS and PFS compared with high-dose chemotherapy and hematopoietic stem cell transplant for relapsed or refractory large B-cell lymphoma, according to topline data released by the agent’s manufacturer.

Researchers evaluated the chimeric antigen receptor T-cell therapy as second-line therapy for adults with previously treated large B-cell lymphoma compared with salvage therapy followed by high-dose chemotherapy and HSCT, which is considered the current standard of care for relapsed or refractory disease.

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Lisocabtagene maraleucel (Breyanzi, Bristol Myers Squibb) — also known as liso-cel — is a gene edited, autologous CAR T-cell therapy that targets the CD19 antigen expressed on the surface of cancer cells. The FDA approved the treatment earlier this year for adults with relapsed or refractory large B-cell lymphoma who received at least two prior therapies and did not have central nervous system disease.

A planned interim analysis by an independent review committee of the ongoing randomized phase 3 TRANSFORM study showed liso-cel achieved the study’s primary endpoint by “demonstrating a clinically meaningful and highly statistically significant improvement in event-free survival, as well as key secondary endpoints of complete response rate and progression-free survival compared to standard of care,” a press release issued by the manufacturer stated.

OS data were not yet mature as of the interim analysis.

Safety results appeared consistent with previous studies of liso-cel as third-line therapy and no new safety issues have emerged during the TRANSFORM study, according to the press release.

“We ambitiously designed the TRANSFORM trial to evaluate Breyanzi’s potential in the second-line setting for patients with relapsed or refractory large B-cell lymphoma against the standard-of-care regimen of high-dose chemotherapy and autologous stem cell transplant,” Noah Berkowitz, MD, PhD, senior vice president of hematology and cell therapy development at Bristol Myers Squibb, said in the release. “These positive interim results build on our commitment to bring CAR T-cell therapies into earlier lines and highlight the potential of Breyanzi to transform the treatment paradigm for this difficult-to-treat disease, possibly supplanting the need for patients to undergo current aggressive treatment regimens.”

Bristol Myers Squibb plans to conduct a complete analysis of the TRANSFORM trial data and present the results at an upcoming medical conference, according to the press release.