FDA Sets Advisory Meeting for Abecma in Supplemental Multiple Myeloma Indication

The FDA will convene a meeting of the Oncologic Drugs Advisory Committee (ODAC) on March 15, 2024, to review data supporting Bristol Myers Squibb’s supplemental biologics license application (sBLA) for Abecma (idecabtagene vicleucel). BMS and partner 2seventy bio are seeking approval of Abecma to treat earlier lines of relapsed or refractory multiple myeloma (RRMM).

The advisory committee will review data related to the secondary endpoint of overall survival from the phase 3 KarMMa-3 study, which met its primary endpoint of improvement in progression-free survival (PFS) compared with standard regimens and reducing the risk of disease progression or death.

Abecma is currently approved to treat patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy. It is a B-cell maturation antigen (BCMA)-directed CAR-T cell immunotherapy. It binds to BCMA, a protein that is expressed on cancer cells in multiple myeloma.

Final progression-free survival data and interim overall survival data were presented at the 2023 American Society of Hematology (ASH) Annual Meeting and Exposition in December 2023. At median follow-up of more than 30 months, Abecma maintained a 51% reduction in risk of disease progression or death with median progression-free survival of 13.8 months compared with 4.4 months for standard regimens. In newly diagnosed multiple myeloma patients, Abecma demonstrated a 77% complete response rate.

The median overall survival was 41.4 months with Abecma and 37.9 months with standard regimens. The study allowed for cross over to Abecma treatment for patients originally assigned to standard regimens. BMS said that when adjusted for crossover, the data showed a median overall survival of 41.4 months for Abecma and 23.4 months for standard regimens.

In patients treated with Abecma with extended follow-up, 88% of patients experiencing any grade cytokine release syndrome; 4% of patients experienced a Grade 3/4 cytokine release syndrome events. Two patients (1%) experienced a Grade 5 cytokine release syndrome event. Additionally, 15% of patients experienced any grade neurotoxicity, with Grade 3/4 neurotoxicity occurring in 3% of patients, and no Grade 5 events reported.

“With longer follow-up from the KarMMa-3 study, we continue to see the significant clinical benefit that Abecma delivers for triple-class exposed multiple myeloma, illustrating the potential of using Abecma for long-term disease control and remission when used earlier in the treatment paradigm,” Paula Rodriguez-Otero, M.D., Ph.D., department of Hematology, Clinica Universidad de Navarra, Pamplona, Spain, said in a press release.

In a separate announcement last week, 2seventy bio said it plans to sell its R&D pipeline to Regeneron to focus exclusively on the commercialization and development of Abecma. A new company will be launched, Regeneron Cell Medicines, which will be led by 2seventy bio’s Chief Scientific Officer Philp Gregory.