Immuno-oncology goes subcutaneous

The downside of having launched one of the best-selling drugs ever is the pain of seeing those sales fall away after patent expiry. In the case of Merck & Co’s Keytruda a subcutaneous formulation might extend market exclusivity, and a pivotal trial that could form the basis for a US filing is about to read out.

With $34bn of forecast 2028 Keytruda sales at stake, little wonder that analysts see the readout, of a lung cancer study called 3475-A86, as a hugely important catalyst. Still, when it comes to SC forms of anti-PD-(L)1 drugs, Roche looks set to get there first: the Swiss company’s SC Tecentriq could be approved as soon as September.