Skip to main content
x

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

Men racing towards the finish line on a track

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

DrugCompanyClinical trialStatus
TecentriqRocheImscin-001 (ph3) backed pharmacokinetics of SC vs IVApproved in GB; US delay over CMC, approval expected 2024
OpdivoBristol Myers SquibbCheckmate-67T (ph3) using syringe & vialShowed non-inferior PK & ORR vs IV Oct 2023
Studies in adjuvant melanoma & others, using autoinjectorTerminated
KeytrudaMerck & CoKeynote-A86 (3wk cycle)Merck disclosed Aug 2023 that study met dual primary endpoints
MK-3475A-C18 (6wk cycle)Ends Sep 2026
ImfinziAstrazenecaScope-D1 (uncontrolled ph1/2) in NSCLC & SCLC (chemo combo)Data due H2 2023
SasanlimabPfizerCrest (ph3) in non-muscle invasive bladder cancerEnds Jun 2024

Source: OncologyPipeline.

Tags

Molecular Drug Targets