NEW YORK – Bristol Myers Squibb on Thursday shared additional data on the activity of its autologous CAR T-cell therapy Breyanzi (lisocabtagene maraleucel) as a second-line large B-cell lymphoma treatment, a setting in which the drugmaker is already seeking the US Food and Drug Administration's approval.
In the Phase II PILOT study, refractory LBCL patients who are ineligible for stem cell transplants after failing first-line treatment demonstrated durable responses, the company announced.
In December, BMS reported positive data from the Phase III TRANSFORM trial, which pitted Breyanzi against a standard-of-care regimen consisting of chemotherapy followed by stem cell transplant. In February, based on those data, the firm filed a supplemental biologics application with the FDA for Breyanzi in second-line relapsed or refractory LBCL. Breyanzi is already approved as a third-line treatment for relapsed or refractory LBCL patients. BMS is expecting the agency to decide on whether to approve the treatment in this earlier, second-line setting by June 24.
If approved, Breyanzi would be the second autologous CAR T-cell therapy commercially available for relapsed or refractory LBCL patients in the second-line treatment setting; early last month, the FDA approved BMS competitor Gilead Science's Yescarta (axicabtagene ciloleucel) in this setting.
According to BMS, however, the new PILOT trial data are the first to clarify the role of CAR T-cell therapy as a second-line option specifically in patients who are ineligible for stem cell transplants.
The single-arm trial evaluated Breyanzi in patients who are ineligible for hematopoietic stem cell transplant based on their age, performance status, or comorbidities. After a median follow-up of 12.3 months, 80 percent of 61 patients treated with Breyanzi experienced a disease reduction, and 54 percent experienced a complete response. The median duration of response was 12.1 months after 15.5 months median follow-up. Among patients who experienced a complete response, the median duration of that response was 21.7 months.
Patients lived for a median of nine months without their cancer progressing, and at the time of the data readout, the median overall survival time was not yet reached. There were no new safety signals seen in the PILOT trial, and only one patient experienced grade 4 or 5 cytokine release syndrome.
Investigators also asked patients in the PILOT trial to report their own outcomes. Among 56 patients included in this analysis, 70 percent said they experienced meaningful improvements in their quality of life after six months of receiving Breyanzi.
BMS plans to report these interim data from the PILOT study, including the patient-reported outcomes, during two separate poster presentations at the American Society of Clinical Oncology's annual meeting next week.