BMS and 2seventy bio report positive phase 3 results for multiple myeloma treatment

Bristol Myers Squibb (BMS) and 2seventy bio – a spin-out of bluebird bio – have announced positive results from a phase 3 trial of their CAR-T cell therapy Abecma (idecabtagene vicleucel) in relapsed or refractory multiple myeloma.

Multiple myeloma is a blood cancer that impacts plasma cells – a type of white blood cell – which are found in the bone marrow.

The American Cancer Society estimates that over 35,000 new cases of multiple myeloma will be diagnosed in the US this year, with over 12,000 deaths expected as a result of the disease.

Paula Rodriguez-Otero from the department of haematology at Clinica Universidad de Navarra said: “In earlier lines of treatment for multiple myeloma, regimens consisting of immunomodulatory agents, proteasome inhibitors, and anti-CD38 monoclonal antibodies are often used to help manage the disease.

“This shift in the treatment paradigm leaves many patients who are triple-class exposed with relapsed and refractory disease and in need of new treatment options sooner.

The companies’ phase 3 KarMMa-3 study compared Abecma with standard combination regimens in adults with relapsed and refractory multiple myeloma after two to four prior lines of therapy

The study met its primary endpoint of progression-free survival, with Abecma demonstrating a 51% reduction in risk of disease progression or death over standard care.

According to the companies, this marks the first time a CAR-T cell therapy has shown superiority over standard regimens in triple-class exposed relapsed and refractory multiple myeloma in a randomised, controlled phase 3 trial.

The therapy also showed an improvement in the key secondary endpoint of overall response rate, with 71% of Abecma-treated patients achieving a response, and 39% achieving a complete or stringent complete response.

In comparison, 41% of patients who received standard regimens achieved a response, and 5% experienced a complete or stringent complete response.

Anne Kerber, senior vice president, cell therapy development at BMS, said: “This represents the third New England Journal of Medicine publication for Abecma, showing the clear clinical benefit of using Abecma across lines of therapy for patients with triple-class exposed relapsed and refractory multiple myeloma to provide the best chance for lasting disease control.”

The companies said in a statement that they intend to include this data in a planned supplemental biologics licence application submission to the US Food and Drug Administration this year.