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
Drug | Company | Clinical trial | Status |
---|---|---|---|
Tecentriq | Roche | Imscin-001 (ph3) backed pharmacokinetics of SC vs IV | Approved in GB; US delay over CMC, approval expected 2024 |
Opdivo | Bristol Myers Squibb | Checkmate-67T (ph3) using syringe & vial | Showed non-inferior PK & ORR vs IV Oct 2023 |
Studies in adjuvant melanoma & others, using autoinjector | Terminated | ||
Keytruda | Merck & Co | Keynote-A86 (3wk cycle) | Merck disclosed Aug 2023 that study met dual primary endpoints |
MK-3475A-C18 (6wk cycle) | Ends Sep 2026 | ||
Imfinzi | Astrazeneca | Scope-D1 (uncontrolled ph1/2) in NSCLC & SCLC (chemo combo) | Data due H2 2023 |
Sasanlimab | Pfizer | Crest (ph3) in non-muscle invasive bladder cancer | Ends Jun 2024 |
Source: OncologyPipeline.
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