Bluebird bio (NASDAQ:BLUE) and licensee Bristol-Myers Squibb (NYSE:BMY) announce positive topline results from a Phase 2 clinical trial, KarMMa, evaluating CAR T therapy idecabtagene vicleucel (ide-cel) (bb2121) in treatment-resistant multiple myeloma (MM) patients.
The study met the primary and key secondary endpoints. Specifically, the overall response rate (ORR) was 73.4% (n=94/128) across three doses (primary endpoint). The response rate was dose-dependent, 50.0% (n=2/4) in the lowest, 68.6% (n=48/70) in the middle and 81.5% (n=44/54) in the highest. The complete response rates were 25%, 28.6% and 35.2%, respectively.
Median duration of response was 10.6 months and median progression-free survival was 8.6 months.
The safety profile was consistent with the Phase 1 CRB-401 trial. The rate of serious/life-threatening/fatal cytokine release syndrome (CRS) was 5.5% (n=7/128) including one death. CRS of any grade occurred in 83.6% of subjects (n=107/128). The rate of serious neurotoxicity events was 3.1% (n=4/128).
More detailed data will be submitted for presentation at a future medical conference.
BMY and BLUE are both up 1% after hours.
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