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Dr Jagannath on Safety Considerations With Ide-Cel in Multiple Myeloma

Sundar Jagannath, MBBS, discusses the FDA’s ODAC Meeting on safety considerations with ide-cel in multiple myeloma.

Sundar Jagannath, MBBS, director, Center of Excellence for Multiple Myeloma, professor, medicine (hematology and medical oncology), The Tisch Cancer Institute, Mount Sinai, discusses takeaways from the FDA’s Oncologic Drugs Advisory Committee (ODAC) Meeting on the safety considerations with idecabtagene vicleucel (ide-cel; Abecma) in patients with relapsed/refractory multiple myeloma.

On March 15, 2024, the ODAC voted 8 to 3 that the benefits of ida-cel outweigh its risks for the treatment of adult patients with relapsed/refractory multiple myeloma who have received an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.

In the phase 3 KarMMA-3 trial (NCT03651128) of ide-cel in patients with relapsed/refractory multiple myeloma, investigators revealed key findings regarding patient survival and treatment complications, Jagannath begins. Similar to allogeneic transplants, some patients experienced infections or other complications despite responding to the treatment. Although there were initial cases of mortality, over time, survival rates improved significantly as patients achieved deep responses, he reports.

Notably, the study involved patients who had undergone 2 to 4 lines of therapy, making their conditions similar to those of late-line therapy patients, he continues. This similarity was due to the upfront use of treatments such as carfilzomib; however, despite these complexities, the study criteria were met, warranting the April 2024 FDA approval of ide-cel for this indication, Jagannath explains.

A particularly impressive aspect of the study was the patient feedback, according to Jagannath. Many patients expressed that ide-cel was life-changing, describing it as a “one and done” treatment that restored their quality of life, Jagannath states. Patients also reported experiencing deep remission without the need for subsequent maintenance therapies, feeling as they did before their multiple myeloma diagnoses. This profound impact on their lives highlighted the importance of making this treatment option widely available to patients, he emphasizes.

Overall, KarMMA-3 demonstrated the significant benefits of ide-cel, showing it as a viable treatment option that could greatly improve the lives of patients with multiple myeloma, Jagannath concludes.

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