BLUE stock closed up 9.4 percent in after-hours trading on December 6, 2019, after the company reported Phase 2 KarMMa study results.

BLUE stock in the 15-minute time frame, surges higher in after-hours trading (brown shaded area) on December 6, 2019.

Bristol-Myers Squibb (BMY) and Bluebird Bio (BLUE) announced positive top-line results from KarMMa, a pivotal, open-label, single arm, multicenter, Phase 2 study of idecabtagene vicleucel. KarMMa, which evaluated the efficacy and safety of the companies’ lead investigational BCMA-targeted chimeric antigen receptor T cell therapy candidate for patients with relapsed and refractory multiple myeloma, met its primary endpoint and key secondary endpoint. KarMMa enrolled 140 patients, of whom 128 patients were treated with ide-cel across the target dose levels of 150-450 x 106 CAR+ T cells. All treated patients were exposed to at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, and all were refractory to their last regimen. 94% of patients were refractory to an anti-CD38 antibody and 84% percent were triple refractory.

“For multiple myeloma patients who have relapsed and become refractory to current treatment options, there remains a high unmet need, as these patients typically experience low response rates, short response durations and poor survival,” said Kristen Hege, M.D., Senior Vice President, Hematology/Oncology and Cell Therapy, Early Clinical Development for Bristol-Myers Squibb. “The KarMMa study provides further support for ide-cel as a potential therapeutic option in this heavily pre-treated patient population, and we are encouraged by these data, especially the outcomes observed at the highest target dose of 450 x 106 CAR+ T cells. We are actively preparing for submission of these data to Health Authorities for proposed initial registration of ide-cel as a first-in-class BCMA-targeted CAR T cell therapy.”

“Multiple myeloma is a relentless disease and there is significant need to find new treatment options for patients who advance through the current therapies available to them,” said Joanne Smith-Farrell, Ph.D., oncology franchise lead and chief business officer, bluebird bio. “With these data in hand, bluebird bio and Bristol-Myers Squibb remain fully focused on advancing ide-cel as quickly as possible for patients in late-line myeloma, while continuing to execute our broad development program to understand the potential benefits of ide-cel across earlier lines of therapy.”

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