FDA approves earlier use of Abecma for triple-class exposed multiple myeloma
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The FDA has approved Bristol Myers Squibb and 2seventy bio’s idecabtagene vicleucel for treatment of patients with triple-class exposed relapsed or refractory multiple myeloma, according to a company release.
This approval expands the indication for idecabtagene vicleucel (Abecma) to include patients who have relapsed or become refractory to a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody after at least two prior lines of therapy.
“Abecma has demonstrated a progression-free survival benefit three times that of standard regimens in relapsed or refractory multiple myeloma, and we are now bringing the promise of cell therapy to patients earlier in their treatment journey,” Bryan Campbell, PharmD, senior vice president and head of commercial and cell therapy at Bristol Myers Squibb, said in the release. “This approval underpins our commitment to addressing the unmet needs of more patients living with multiple myeloma by improving upon the current treatment paradigm, and we remain steadfast in our pursuit of innovation and advancing cell therapy research to deliver potentially transformative therapies.”
The agency based its decision on data from the phase 3 KarMMa-3 trial, in which idecabtagene vicleucel was compared with standard of care therapy among patients with triple-class exposed relapsed and refractory multiple myeloma who had received two to four prior lines of treatment. In addition, these patients were also refractory to their last treatment regimen, with 94% of patients reported to be disease refractory to prior treatment with daratumumab (Darzalex, Janssen).
Patients were randomly assigned to receive either idecabtagene vicleucel (n = 254) or standard of care therapy (n = 132), which included combinations consisting of:
- daratumumab, pomalidomide and dexamethasone;
- daratumumab, bortezomib and dexamethasone;
- ixazomib (Ninlaro, Takeda), lenalidomide and dexamethasone;
- carfilzomib and dexamethasone; and
- elotuzumab (Empliciti, Bristol Myers Squibb), pomalidomide and dexamethasone.
After an estimated median follow-up of 15.9 months, treatment with idecabtagene vicleucel more than tripled progression-free survival — 13.3 months (95% CI, 11.8-16.1) vs. 4.4 months (95% CI, 3.4-5.9) in the standard of care groups (HR = 0.49; 95% CI, 0.38-0.64; P < .0001) — and a 51% reduced risk for disease progression or death.
Idecabtagene vicleucel also demonstrated significant improvement in overall response rates (P < .0001) with the majority (71%) of patients who received idecabtagene vicleucel attaining a response. Additionally, 39% of patients achieved a complete or stringent complete response vs. only 5% of patients who received standard of care.
These responses achieved with idecabtagene vicleucel were also durable, with a median duration of response of 14.8 months (95% CI, 12-18.6) among those who experienced a partial response or better. Further, in patients who achieved a complete response or better, median duration was even longer at 20 months (95% CI, 15.8-24.3).
“The results of the KarMMa-3 study are remarkable, especially given the historic outcomes with standard regimens for these patients with relapsed or refractory disease,” Al-Ola A. Abdallah, MD, clinical director of Hematologic Malignancies and Cellular Therapeutics at the University of Kansas and chair of U.S. Myeloma Innovations Research Collaborative, said in the release. “With this approval, these patients now have an opportunity to be treated at an earlier line of therapy with a potentially transformative therapy that offers significantly improved progression-free survival for this difficult-to-treat disease that has had no established treatment approach.”
Idecabtagene vicleucel includes a boxed warning that outlines risks for CRS, neurotoxicity, HLH/MAS, prolonged cytopenia and secondary hematological malignancies associated with CAR T-cell therapy.
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