Abecma (Idecabtagene Vicleucel) Demonstrates 51% Reduction in Risk of Disease Progression or Death in First-Ever Phase III Trial for Relapsed/Refractory Multiple Myeloma

On February 10, Bristol-Myers Squibb (BMS) and 2seventy bio announced positive results from the KarMMa-3 study at the EHA (European Hematology Association) Congress. This pivotal Phase III, open-label, global, randomized, controlled trial evaluated the efficacy of Abecma (idecabtagene vicleucel) compared to standard combination regimens in adult patients with relapsed and refractory multiple myeloma. Participants had previously received 2-4 prior treatment regimens, including immunomodulatory agents, proteasome inhibitors, and anti-CD38 monoclonal antibodies, and were refractory to their last treatment regimen. The study results were simultaneously published in The New England Journal of Medicine.

Source: The New England Journal of Medicine

At a median follow-up of 18.6 months, patients treated with Abecma (n=254) showed clinically meaningful and statistically significant improvement in the primary endpoint of progression-free survival (PFS) compared to the standard regimen (n=132). The median PFS was 13.3 months (95% CI: 11.8-16.1) vs. 4.4 months (95% CI: 3.4-5.9) (HR: 0.49; p<0.0001). This indicates that Abecma reduced the risk of disease progression or death by 51%. The results of KarMMa-3 suggestAbecma is the first CAR-T cell therapy proven to be more effective than standard treatment in patients with triple-class refractory multiple myeloma in a Phase III randomized controlled trial.。

The results for the key secondary endpoint of overall response rate (ORR) were also statistically significant, with the majority of patients (71%) receiving Abecma achieving a response, and 39% achieving a complete response or stringent complete response. In contrast, less than half (41%) of the standard regimen group achieved a response, with 5% achieving a complete response or stringent complete response (p<0.0001). Responses to Abecma were durable, with a median duration of 14.8 months (95% CI: 12.0-18.6), compared to 9.7 months (95% CI: 5.4-16.3) in the standard regimen group.

Multiple Myeloma (MM) is a malignant disease characterized by the abnormal proliferation of clonal plasma cells. It is the second most common hematologic malignancy in many countries and primarily affects the elderly. Despite recent advancements in treatment, MM remains an incurable disease marked by periods of remission and relapse. Most patients experience recurrence after initial therapy, with the degree and duration of response, as well as survival outcomes, diminishing with each subsequent treatment. Patients with relapsed or refractory MM who have been exposed to the three main drug classes—immunomodulatory agents, proteasome inhibitors, and anti-CD38 antibodies—have poor clinical prognoses, with response rates of only 20%-30%, remission durations of just 2-4 months, and very low survival rates.

Abecma was approved by the FDA in March 2021 based on pivotal Phase II KarMMa study data for the treatment of adult patients with relapsed or refractory multiple myeloma who have received four or more prior lines of therapy. It is the first CAR-T cell immunotherapy targeting B-cell maturation antigen (BCMA) approved by the FDA. The positive results from this Phase III study once again demonstrate its efficacy.

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