Bristol Myers Squibb (BMS) and 2seventy bio have unveiled their plans to discontinue enrolment of subjects in the Phase 3 KarMMa-9 study of Abecma for treating newly diagnosed multiple myeloma (NDMM).
The study evaluates Abecma plus lenalidomide maintenance, compared to lenalidomide maintenance alone in patients with NDMM who have a poor response to stem cell transplant.
KarMMa-9 is designed based on positive data from the KarMMa-2 trial, which showed favourable results for Abecma in a similar patient population.
The decision to suspend the Phase 3 study is based on the evolving treatment landscape for NDMM, with fewer eligible patients due to an increase in treatment options, said BMS.
BMS and 2seventy bio intend to work with investigators to determine the next steps for patients currently enrolled in the KarMMa-9 study.
Bristol Myers Squibb senior vice president, late clinical development, haematology, oncology and cell therapy (HOCT) head Anne Kerber said: “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.
“We celebrate this progress for patients while also recognising that it reduces the eligible patient population for, and viability of, the KarMMa-9 trial.”
Abecma is a genetically modified autologous T-cell immunotherapy that targets B-cell maturation antigen (BCMA) on the surface of multiple myeloma cells.
The drug is being jointly developed and marketed in the US, as part of a co-development, co-promotion, and profit share agreement between Bristol Myers Squibb and 2seventy bio.
Earlier this year, Abecma received the US Food and Drug Administration (FDA) approval for the treatment of adults with relapsed or refractory multiple myeloma, who received prior treatment.
2seventy bio chief executive officer Chip Baird said: “With a greatly improved NDMM treatment landscape and following our rigorous review of the business case for the KarMMa-9 study, we have decided to discontinue enrollment in this Phase 3 study.
“Abecma continues to show encouraging signs of growth with an expanded label in the third line and a differentiated safety profile.
“Consistent with our focus on capital allocation and creating value for all stakeholders, we anticipate this decision will conserve over $80m in near-term expenditures and accelerate our path to breakeven in 2025.”
