Junshi is next with a subcutaneous PD-1

The development of subcutaneously delivered anti-PD-(L)1 antibodies has so far delivered four approved drugs, and there could soon be a fifth, with Shanghai Junshi this week toplining the success of a phase 3 study of a SC form of toripalimab. The trial tested chemo combos of a SC version (JS001sc) versus the IV form in first-line non-squamous non-small cell lung cancer, and was said to have shown comparable efficacy and safety, and non-inferior pharmacokinetics. Junshi says the data will back a Chinese filing across all indications where the IV form, Tuoyi, is approved; these presently number 12 cancer settings. In the US toripalimab is licensed to Coherus, and approved IV in two nasopharyngeal carcinoma settings as Loqtorzi, but it’s unclear whether Coherus holds specific rights to a SC version. With Tecentriq Hybreza, Opdivo Qvantig and Keytruda Qlex not approved in China, JS001sc’s local SC competition is limited to Alphamab’s envafolimab, an anti-PD-L1/Fc fusion protein with high solubility. Pfizer’s sasanlimab is awaiting approval in the EU for non-muscle invasive bladder cancer, but a US filing hasn’t yet been publicly disclosed.

Subcutaneously delivered anti-PD-(L)1 MAbs

Source: OncologyPipeline.