Bristol Myers Squibb (BMS) has reported positive top-line results from the registrational Phase II QUINTESSENTIAL trial of arlocabtagene autoleucel (arlo-cel; BMS-986393) in adults with quadruple-class exposed relapsed and refractory multiple myeloma (r/r MM).
Arlo-cel is an autologous G protein-coupled receptor class C group 5 member D (GPRC5D)-directed chimeric antigen receptor T cell (CAR T cell) therapy.
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The multi-centre, single-arm, open-label study achieved its primary endpoint, with a statistically significant and clinically meaningful overall response rate in patients who had received at least four prior lines of therapy.
These prior treatments included immunomodulatory, proteasome inhibitors, anti-cluster of differentiation 38 (CD38) therapies, and B-cell maturation antigen (BCMA)-targeted therapies.
The pivotal trial is described as the first to assess a treatment in this patient population following exposure to prior BCMA-targeted therapies.
Key secondary endpoints were also met, with the therapy achieving a complete response rate in r/r MM patients who had been quadruple-class exposed after four or more previous treatments.
Additionally, arlo-cel showed key secondary endpoint results for overall response rate and complete response rate in patients who had received at least three prior lines of therapy.
The safety profile observed was in line with that of other CAR T-cell and GPRC5D-targeting therapies in MM.
BMS cell therapy organisation president Lynelle Hoch said: “As combination treatment regimens are now frequently used in earlier lines of therapy, an increasing number of people with multiple myeloma are quadruple-class exposed and resistant to currently available therapies earlier in the treatment journey, creating a critical need for new therapeutic approaches.
“These top-line results support arlo-cel’s potential benefit for patients while showing a safety profile consistent with expectations. They underscore our continued innovation in multiple myeloma and highlight the value of targeting alternative proteins, like GPRC5D, with the power of cell therapy to transform outcomes, laying the foundation for arlo-cel to become an important treatment option for this emerging group of patients who have been exposed to prior BCMA-targeted therapies.”
The study is evaluating the efficacy and safety of arlo-cel in patients who have previously received CAR T cell therapies.
Earlier this year, BMS reported positive top-line results from the Phase III SCOUT-HCM trial assessing Camzyos (mavacamten) for the treatment of symptomatic obstructive hypertrophic cardiomyopathy.
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