Roche tries to jump ahead with subcutaneous Tecentriq

While Pfizer and Merck & Co have made much of subcutaneous PD-(L)1 inhibitors – and their concomitant patent protection – Roche’s progress has been quieter. But today the Swiss firm tried to jump ahead, saying it would take to the regulators newly generated data from the Imscin-001 study of a SC form of Tecentriq in post-chemo NSCLC. Imscin-001’s phase 1 results showed the SC form to have similar serum trough concentration to IV, and the phase 3 part has now shown pharmacokinetic exposure of SC to be non-inferior to IV. Roche’s new formulation uses Halozyme’s Enhanze technology, which also lies behind its SC forms of Rituxan and Herceptin, and which is also the secret sauce in Bristol Myers Squibb’s SC nivolumab. As far as more convenient options go, SC has clearly overtaken oral delivery; Gilead’s oral PD-L1 inhibitor GS-4224 has been discontinued, while shows no active studies of Curis’s small-molecule anti-PD-L1/Vista, CA-170. Last November Alphamab hailed envafolimab as the world’s first SC anti-PD-L1 MAb when this was approved in China for MSI-high or dMMR solid tumours.

Selected trials of subcutaneous PD-(L)1 inhibitors
Study Design Primary completion
SC form of Tecentriq (Roche)
BP40657 SC vs IV in 2L NSCLC Apr 2022
Imscin-001* SC vs IV in 2L NSCLC Has data backing pharmacokinetics of SC vs IV
SC form of Keytruda (Merck & Co)
3475-A86 SC vs IV chemo combo in 1L NSCLC Feb 2023
SC form of Opdivo (Bristol Myers Squibb)
Checkmate-67T SC vs IV in renal cell carcinoma Dec 2023
Checkmate-6GE SC vs IV in melanoma Dec 2023
Envafolimab (KN-035; Tracon/Alphamab/3D Medicines)
KN035-BTC Biliary tract cancer Jan 2024 (last year delayed from 2021)
Sasanlimab (Pfizer)
Crest Non-muscle invasive bladder cancer Jun 2024
SC form of Imfinzi (Astrazeneca)
Scope-D1** NSCLC & SCLC Jan 2024
Note: *phase 1b/3; **phase 1/2; all others are phase 3. Source:

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