Data Supporting Liso-Cel for R/R LBCL Treatment

Manali Kamdar, MD, the clinical director of Lymphoma Services at the University of Colorado Medicine, discusses data from the 2 clinical trials that supported the recent FDA approval of lisocabtagene maraleucel (liso-cel; Breyanzi) for the treatment of patients with relapsed or refractory large B-cell lymphoma (LBCL)

As Kamdar explains, the data come from the phase 3 TRANSFORM trial (NCT03575351) and the phase 2 PILOT trial (NCT03483103). Kamdar’s key takeaways from the research are that liso-cel has the potential to fill a treatment gap in LBCL, and shift the standard of care.

Transcription:

0:07 | We are very delighted at this point, based on the FDA approval for liso-cel, and at this point, I do have to say it probably has the broadest approval within the CAR T-cell therapy space for patients with relapsed or refractory aggressive large B-cell lymphoma. And it comes secondary to the TRANSFORM study, which is a phase 3 pivotal, randomized study. The study compared patients who have high-risk relapsed diffuse large B -cell lymphoma and are transplant eligible. The patients were randomized to either getting is salvage chemo, which has been the standard of care for nearly three decades, followed by a transplant versus liso-cel.

0:52 | The second study where the approval came from is for transplant-ineligible patients based on the PILOT study. This was a phase 2 study that was done in patients that were transplant-ineligible and have relapsed diffuse large B-cell lymphoma after 1 line of treatment.

1:10 | For me the key takeaways are the fact that for patients who are transplant-eligible relapsed/refractory diffuse large B-cell lymphoma that has recurred within a year after receiving primary treatment, or have not responded to primary treatment at all, their survival is extremely dismal. Typically, the standard of care is certainly something that can help patients, but only a quarter of transplant-eligible patients derive long-term durable benefit. So, this huge unmet need.

1:47 | The TRANSFORM study demonstrated that liso-cel as compared to the standard of care was statistically significant and clinically meaningful with respect to its benefit, and it met its primary end point, which is the event-free survival. It nearly quadrupled on the liso-cel ell arm with an event-free survival of 10 months versus a dismal of only 2 months on the standard of care arm. It also did meet some of its key secondary end points for example, complete response rate and progression-free survival.

2:16 | Very interestingly, the overall survival data although immature, appears to favor liso-cel. So, the follow-up of this study in the primary analysis is awaited. And then, in the PILOT study, what was tested was the other unmet need, which is patients who are transplant ineligible. They also have relapsed/refractory diffuse large B-cell lymphoma after failure of 1 line of treatment. There is no standard of care for those patients, and usually, the survival is extremely dismal. In the PILOT study, they demonstrated that the overall response rate was high at 80% with a complete response rate of nearly 54%. And in patients who especially achieved the complete remission, their median duration of response was very high. So, I think liso-cel, based on these 2 studies filled in this unmet need not just in the transplant eligible but also in the transplant-ineligible space for patients with aggressive large B-cell lymphoma that have relapsed or refractory disease after failure of 1 line of treatment.