Sanofi comes up against a graft-versus-host disease rock

Sanofi’s hopes of expanding its approved Rock2 inhibitor Rezurock into earlier lines of chronic graft-versus-host disease have taken a blow with the failure of the Rocknrol-1 phase 3 study in first-line disease. The company slipped the news into its second-quarter earnings release on Thursday, saying only that the trial would be discontinued following a prespecified interim analysis for futility. Rezurock was FDA approved in third-line GvHD in July 2021, and Sanofi bought its originator, Kadmon, for $1.9bn two months later. Since then sales have climbed steadily, to €470m in 2024, although a first-line label could presumably have supercharged growth. Rocknrol-1 compared Rezurock plus steroids against steroids alone, in newly diagnosed GvHD. The primary endpoint was event-free survival. Studies are also ongoing to evaluate whether Rezurock can prevent GvHD in patients undergoing stem cell transplantation, but these are investigator sponsored. Sanofi, meanwhile, has included Rezurock in the phase 1/2 Umbrella multiple myeloma trial, testing various assets in combination with its anti-CD38 MAb Sarclisa. The only other Rock2 inhibitor in development, according to OncologyPipeline, is Tide Pharmaceutical’s TDI01, although that’s only being studied in China.

Rock2 inhibitors in clinical development

Source: OncologyPipeline & company release.