Dr. Giralt on the Evaluation of Ide-cel in Triple-Class Exposed R/R Myeloma

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.