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FDA Approves Bristol Myers Squibb's Breyanzi for Second-Line Lymphoma Patients

NEW YORK – The US Food and Drug Administration on Friday approved Bristol Myers Squibb's CD19-targeted CAR T-cell therapy Breyanzi (lisocabtagene maraleucel) as a second-line treatment for relapsed or refractory large B-cell lymphoma.

LBCL patients are now eligible for treatment with the autologous CAR T-cell therapy if their cancer does not respond at all to or relapses within a year of first-line chemotherapy, or if it relapses within a year of chemo and is also not eligible for hematopoietic stem cell transplant.

The FDA based its decision on the results of the Phase III TRANSFORM trial and the Phase II PILOT trial. In TRANSFORM, relapsed or refractory LBCL patients on Breyanzi after one prior line of treatment had a median event-free survival of 10.1 months, whereas patients on a standard-of-care regimen of intensive chemo — and stem cell transplant, if they responded to chemo — had a median event-free survival of 2.3 months.

Sixty-six percent of patients experienced a complete response after Breyanzi, versus 39 percent of patients on standard treatment. Progression-free survival times were also improved with Breyanzi: Patients receiving the CAR T-cell therapy lived a median of 14.8 months without their disease progressing versus 5.7 months for patients treated with standard of care.

In PILOT, Breyanzi led to an 80 percent overall response rate and a 54 percent complete response rate among LBCL patients who were not candidates for a stem cell transplant. The median duration of response was 11.2 months, and for patients who experienced a complete response, the median duration of response was not yet reached.

BMS's autologous cell therapy, which can be administered in the inpatient or outpatient setting, now competes with Gilead Sciences' Yescarta (axicabtagene ciloleucel), which the FDA approved for second-line LBCL in April.

BMS last week submitted an application to the European Medicines Agency seeking approval for Breyanzi in second-line LBCL.

The therapy, which involves harvesting patients' own immune cells, engineering them to target CD19 on the surface of cancer cells, and reinfusing them as a one-time treatment following lymphodepleting chemotherapy, is also approved for later-line LBLC, after two or more prior treatments.