Breaking Down The Results of The ALPHA/ALPHA2 Study in Large B-Cell Lymphoma

Cemacabtagene ansegedleucel (cema-cel; formerly ALLO-501/A) is an off-the-shelf allogeneic CAR-T cell therapy, Dr. Frederick L. Locke described in an interview with CURE®, saying that treatment with the CAR-T product demonstrated responses in patients with relapsed/refractory large B-cell lymphoma.

These responses were recorded in findings from the phase 1 ALPHA/ALPHA2 study, which were shared in a press release from Allogene Therapeutics, Inc. Among heavily pretreated patients, the selected phase 2 regimen achieved an overall response rate of 67% and a complete response rate of 58%, with a median duration of response of 23.1 months, Locke explained. Moreover, the safety profile was manageable, with no severe cytokine release syndrome (CRS) or neurotoxicity observed.

Locke serves as an investigator of cema-cel, as well as the chair of the Department of Blood and Marrow Transplant and Cellular Immunotherapy at Moffitt Cancer Center and Research Institute, in Tampa, Florida. In the interview with CURE, he expanded on the key takeaways derived from the trial. Read more from Locke and learn more about cema-cel here.

Transcript

The ALPHA/ALPHA2 trial is a phase one, single-arm clinical trial that which tests the safety and efficacy of cema-cel in large B-cell and relapsed/refractory non-Hodgkin lymphoma. The results in patients with large B-cell lymphoma [show] that it can be safely administered and [oncologists are] able to manage side effects. It certainly can cause cytokine release syndrome [CRS] — which is fevers — which are common with autologous CAR-T cell therapy, the FDA-approved CAR-T cell therapies. With cema-cel we only saw CRS in about a quarter of patients, and no severe CRS [was reported]. We didn't see any neurologic toxicity that we commonly see with autologous CAR-T.

We tested [cema-cel] out in patients who had already [been treated with] several lines of treatment and the efficacy results were very intriguing and exciting. We saw that 58% of patients had a response, and 42% of patients had a complete response, or complete disappearance of their lymphoma on the ALPHA/ALPHA2 studies. This this is comparable with autologous CAR-T cell [therapy], but because it's allogeneic, we can give the cells almost immediately to our patients. We don't have to wait a month for the CAR-T cells to be made. [Therefore], it has some advantages over autologous CAR-T.

Transcript was edited for clarity and conciseness.

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