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 clinicaltrials.gov 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.