NEW YORK – Bristol Myers Squibb and 2seventy Bio on Wednesday said they are discontinuing enrollment in the Phase III KarMMa-9 study evaluating maintenance treatment with CAR T-cell therapy Abecma (idecabtagene vicleucel) with immunomodulator Revlimid (lenalidomide) in patients with newly diagnosed multiple myeloma.
The study was comparing the Abecma-Revlimid combination to Revlimid alone in the maintenance setting for multiple myeloma patients who had suboptimal response after autologous stem cell transplant.
However, BMS and 2seventy said the treatment landscape in this setting has changed since the trial was designed with the advancement of more intense and prolonged induction therapies in the first-line setting. This has resulted in fewer patients eligible for the KarMMa-9 study.
With the study open for one year in 18 countries, the firms said only 10 percent of the study population has been enrolled to date. They had expected the trial would enroll up to 618 patients.
"Investigators indicate that due to advances in induction therapies, a significant majority — upwards of 70 percent — of patients with newly diagnosed multiple myeloma are now achieving a complete response or better following transplant," Anne Kerber, senior VP and head of late clinical development, hematology, oncology, and cell therapy at Bristol Myers Squibb, said in a statement. "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 said they will work with trial investigators to determine next steps for patients currently enrolled in KarMMa-9.
Abecma is approved in the US as a third-line or later treatment for patients with relapsed or refractory multiple myeloma. BMS and 2seventy are also studying Abecma in earlier lines of treatment for multiple myeloma in other ongoing studies, including in newly diagnosed, high-risk patients.