One subcutaneous form goes, but the Opdivo dream continues

 With Roche gunning for US approval of subcutaneously delivered Tecentriq by its 15 September Pdufa date today’s disclosure that Bristol Myers Squibb had terminated a SC Opdivo programme raises eyebrows. Still, the SC Opdivo idea is far from over, Bristol executives stressed on a first-quarter call today; the renal cancer Checkmate-67T trial, using a syringe and vial, is continuing. Instead, it is the seemingly more convenient autoinjector programme that has been discontinued. Samit Hirawat, Bristol’s chief medical officer, told analysts that the latter had not shown sufficient “additional benefit for continuing ... at this time”. For its part, Merck & Co, which has the most to lose from patent expiry on IV Keytruda, again played up its own work with SC delivery. While a study without a hyaluronidase formulation ends imminently, this uses a three-week dosing cycle. But Merck wants the convenience of three as well as six-week dosing, it said today on its earnings call, and for the latter use it has co-formulated Keytruda with a recombinant hyaluronidase coded MK-5180. However, a trial of this will not read out for some time.

Some subcutaneous PD-(L)1 projects in the clinic
Drug	Company	Formulation	Clinical trial(s)	Status
Tecentriq	Roche	With Halozyme's Enhanze rHyPH20 (hyaluronidase)	Inscin-001 (ph3) backed pharmacokinetics of SC vs IV	Filed in US, Pdufa date 15 Sep 2023
Keytruda	Merck & Co	No hyaluronidase	3475-A86 (3wk cycle)	Reads out imminently
		With MK-5180 (rh hyaluronidase)	MK-3475A-C18 (6wk cycle)	Ends Sep 2026
Opdivo	Bristol Myers Squibb	With Halozyme's Enhanze rHyPH20 (hyaluronidase)	Checkmate-67T (ph3) using syringe & vial	Ends Dec 2023
			Studies in adjuvant melanoma & others, using autoinjector	Terminated
Imfinzi	Astrazeneca	Unclear	Scope-D1 (uncontrolled ph1/2) in NSCLC & SCLC (chemo combo)	Ends Sep 2023
Sasanlimab	Pfizer	No additional modification	Crest (ph3) in non-muscle invasive bladder cancer	Ends Jun 2024
Source: clinicaltrials.gov & company statements. https://www.evaluate.com/vantage/articles/news/snippets/one-subcutaneous-form-goes-opdivo-dream-continues