Sanofi’s Sarclisa gets one up on Darzalex

In the CD38-targeting world Sanofi’s Sarclisa has long been seen as a poor cousin to Genmab and Johnson & Johnson’s Darzalex. But Sanofi got one up on its rival on Thursday, toplining a win in a setting in which a Darzalex study has apparently been delayed. Sanofi’s success came in the phase 3 Imroz trial, which tested Sarclisa plus Velcade, Revlimid and dexamethasone, versus the triplet alone, in first-line multiple myeloma patients ineligible for transplant. All Sanofi said was that the trial met its primary endpoint, progression-free survival. Meanwhile, the analogous Darzalex study, Cepheus, was once expected to read out this year, but is no longer listed among J&J’s 2023 milestones, and its primary completion date is now August 2025. Shifting to the transplant-eligible setting, Darzalex’s Genmab’s Perseus trial was just unveiled as a late-breaker at the ASH meeting. Sanofi has already claimed a win here with the investigator-sponsored GMMG HD7 trial; however, results so far have been limited to minimal residual disease negativity. Sanofi plans filings next year, but has a lot of ground to make up: Sarclisa, approved in late-line multiple myeloma, sold $278m in the first nine months of this year, versus Darzalex’s $7.2bn.

Sarclisa vs Darzalex: notable first-line studies

Note: all involved CD38 antibodies being given on top of Velcade, Revlimid and dexamethasone (VRd), vs VRd alone; *investigator sponsored. Source: OncologyPipeline.