Roche’s (VTX:ROG) Phase I study of its Tecentriq (atezolizumab) combination in relapsed/refractory multiple myeloma (MM) will resume enrolling patients in a matter of weeks, a source familiar with the study said.
The combination is evaluating Tecentriq -- a PD-L1 inhibitor -- in combination with Johnson & Johnson’s (NYSE:JNJ) Darzalex (daratumumab) and Celgene's (NASDAQ:CELG) immunomodulating drugs (iMiDs) Revlimid (lenalidomide) and Pomalyst (pomalidomide). However, the source said it will only enroll patients in the Tecentriq/Darzalex and Tecentriq/Darzalex/Pomalyst cohorts and not the arms including Revlimid.
The FDA suspended the study in September 2017 amid safety concerns around PD-1 and PD-L1 checkpoint inhibitors combined with iMiDs in MM following the news that Merck’s (NYSE:MRK) Phase III KEYNOTE-183 (NCT02576977) and KEYNOTE-185 (NCT02579863) studies -- combining the PD-1 inhibitor Keytruda (pembrolizumab) with either Pomalyst/dexamethasone or Revlimid/dexamethasone -- showed more deaths in the triplet-combination arms than in the iMiD/dexamethasone arms. Both Merck studies have remained suspended since July 2017.