Bristol Myers Squibb and 2seventy bio Provide Update on KarMMa-9 Trial of Abecma in Patients with Newly Diagnosed Multiple Myeloma

Bristol Myers Squibb and 2seventy bio have made the difficult decision to discontinue enrollment in the Phase 3 KarMMa-9 study investigating Abecma^® (idecabtagene vicleucel) with lenalidomide maintenance versus lenalidomide maintenance alone in patients with newly diagnosed multiple myeloma (NDMM) who have suboptimal response after autologous stem cell transplant. We designed KarMMa-9 based on positive data from cohort 2c of the KarMMa-2 trial, which demonstrated a favorable benefit/risk profile for Abecma in a similar patient population. Since then, however, the NDMM treatment landscape has changed considerably with the evolution of more intense and prolonged induction therapies, resulting in fewer eligible patients for KarMMa-9. The trial has been open for over one year in 18 countries but has faced enrollment challenges; despite numerous collaborative efforts with investigators and study staff to support recruitment, only 10% of the study population has been accrued to date.

"Investigators indicate that due to advances in induction therapies, a significant majority - upwards of 70% - of patients with newly diagnosed multiple myeloma are now achieving a complete response or better following transplant," said Anne Kerber, senior vice president, Head of Late Clinical Development, Hematology, Oncology and Cell Therapy (HOCT), Bristol Myers Squibb. "We celebrate this progress for patients while also recognizing that it reduces the eligible patient population for, and viability of, the KarMMa-9 trial."

BMS and 2seventy bio will work with investigators to determine appropriate next steps for patients currently enrolled in the KarMMa-9 study. We express our sincere gratitude to the patients who participated in the trial, and to the investigators and study staff for their collaboration.

We strongly believe in the value Abecma brings to patients and the important role it plays in the multiple myeloma treatment paradigm. BMS will continue to expand the reach of Abecma to as many patients globally as possible, both commercially and through ongoing bridging and combination studies.

Multiple myeloma is a key area of focus for BMS, and we remain committed to advancing the science to address unmet patient needs. BMS is actively recruiting patients with multiple myeloma for several studies across four novel assets from our diverse cell therapy and protein degradation pipeline.