Abecma Clinical Trial Data

Abecma Clinical Trial Data

Abecma is a CAR-T cell immunotherapy targeting BCMA, which is expressed on the surface of multiple myeloma cells. Abecma can recognize and bind to BCMA, leading to the proliferation and differentiation of CAR-T cells, subsequently killing cells expressing BCMA.

Abecma received two approvals from the U.S. Food and Drug Administration (FDA):

First approval on March 26, 2021

On March 26, 2021, Abecma was approved by the FDA for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.

Abecma Phase II Clinical Trial (KarMMa) Data

The FDA’s approval was based on data from the Phase II KarMMa trial.

The evaluable population consisted of 100 patients who received Abecma.

88% of these patients had received four or more prior lines of therapy, and 85% were triple-class refractory.

The data showed an overall response rate (ORR) of 72%, with 29% of patients achieving a stringent complete response (sCR). Responses were rapid and durable.

The median time to sCR was 30 days, and the median duration of response was 11 months, with a median duration of 21 months for the longest responders.

Approximately 65% of the 28 patients who achieved sCR maintained their response for at least 12 months.

Second approval on April 5, 2024

On April 5, 2024, the FDA approved ciltacabtagene autoleucel (Carvykti, Abecma) for the treatment of relapsed or refractory multiple myeloma in patients who have received at least one prior line of therapy.

Abecma Phase III Clinical Trial (KarMMa-3) Data

This approval was based on positive results from the Phase III KarMMa-3 trial. In this study, 254 patients were randomized to receive Abecma, and 132 patients were randomized to receive standard regimens chosen based on their most recent therapy and investigator’s choice.

At a median follow-up of 15.9 months, Abecma significantly prolonged the primary endpoint of median progression-free survival (PFS) to 13.3 months (95% CI: 11.8-16.1) compared to 4.4 months (95% CI: 3.4-5.9) in the active control arm (HR: 0.49; 95% CI: 0.38-0.64; p<0.0001), representing a 51% reduction in the risk of disease progression or death.

Abecma also demonstrated a significant improvement in overall response rate (p<0.0001), with the majority (71%) of patients achieving a response, and 39% achieving a complete response or stringent complete response, compared to less than half (42%) and 5%, respectively, in the standard regimen arm. The median duration of response with Abecma was 14.8 months (95% CI: 12.0-18.6).