Update on KarMMa-9 trial of Abecma (idecabtagene vicleucel) + with lenalidomide maintenance in patients with newly diagnose multiple myeloma

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.