Sergio A. Giralt, MD, discusses the investigation of idecabtagene vicleucel vs standard-of-care regimens in patients with triple-class exposed relapsed/refractory multiple myeloma in the phase 3 Karmma-3 trial.
Sergio A. Giralt, MD, deputy division head, Division of Hematologic Malignancies, Melvin Berlin Family Chair in Multiple Myeloma, Memorial Sloan Kettering Cancer Center, discusses the investigation of idecabtagene vicleucel (ide-cel; Abecma) vs standard-of-care regimens in patients with triple-class exposed relapsed/refractory multiple myeloma in the phase 3 Karmma-3 trial (NCT03651128).
The international, open-label study evaluated ide-cel vs standard-of-care regimens in patients with multiple myeloma who had previously received 2 to 4 regimens and were refractory to their last treatment. Standard regimens included daratumumab (Darzalex), pomalidomide (Pomalyst), and dexamethasone; daratumumab, bortezomib (Velcade), and dexamethasone; ixazomib (Ninlaro), lenalidomide (Revlimid), and dexamethasone; carfilzomib (Kyprolis) and dexamethasone; or elotuzumab (Empliciti), pomalidomide, and dexamethasone.
The primary end point of this trial was progression-free survival (PFS), and in this specific patient population, the expected PFS with standard treatments is between 3 and 5 months, Giralt says.
Patients were randomly assigned in a 2:1 fashion, with 254 patients assigned to ide-cel and 132 assigned to standard treatment regimens, Giralt says. In the ide-cel arm, 249 patients underwent leukapheresis and 213 patients received bridging therapy, Giralt expands.
Findings showed that ide-cel elicited a median PFS of 13.3 months vs 4.4 months for patients in the control group, Giralt continues. Additionally, patients treated with ide-cel experienced an overall response rate of 71% compared with 42% for those treated with standard of care, and the complete remission rates were 35% for the ide-cel group vs 5% in the control group. Notably, 50% patients who experienced a complete remission in the ide-cel group were minimal residual disease negative, compared with only 1% in the control group, Giralt concludes.