Bristol nips at Roche’s heels in the subcutaneous PD-1 race

Checkpoint inhibitor developers are turning to subcutaneous formulations as a way to extend their blockbuster franchises, and yesterday Bristol Myers Squibb took another step towards SC Opdivo. The company disclosed that in the Checkmate-67T trial in renal cancer the SC formulation was non-inferior to IV Opdivo on pharmacokinetic co-primary endpoints, as well as on the secondary endpoint of ORR. The trial used a syringe and vial formulation; Bristol had discontinued a seemingly more convenient autoinjector earlier this year. The company looks to be catching up with Roche, whose SC Tecentriq had a PDUFA date of 15 September, but has been delayed by manufacturing issues. During its fourth-quarter results yesterday Roche said it now expected FDA approval in 2024. Meanwhile Merck & Co, whose Keytruda dominates the PD-(L)1 landscape, quietly slipped out in an August SEC filing that Keynote-A86 had succeeded. That study evaluated SC Keytruda given every three weeks, but the company has recently been highlighting the potential of a SC Keytruda/hyaluronidase combo that could push dosing to every six weeks. However, a phase 3 trial of the latter does not end until 2026. 

Selected subcutaneous PD-(L)1 projects in the clinic

Source: OncologyPipeline.