Itovebi’s window of opportunity

With Roche’s oncology pipeline seen by many to be failing to live up to former glories, US approval of its breast cancer drug Itovebi comes as a welcome development. However, the drug, an alpha subunit-selective PI3K inhibitor, might already appear marginalised: Novartis’s first-in-class PI3Kα inhibitor Piqray is seeing declining sales, and the field has moved on to molecules specific for mutated PI3Kα (Piqray and Itovebi both hit the wild-type and mutant forms, though the latter has also been said to degrade mutant PI3Kα). Still, Itovebi’s label shows a less onerous warning section than Piqray’s, and the Roche drug has been approved, over a month before its 27 November PDUFA date, in a front-line setting, versus Piqray’s second-line use. Not only that, but Piqray isn’t being studied in first line, and Roche has thrown down the gauntlet to its rival, running the Inavo-121 trial in which it’s pitting Itovebi head to head against Piqray; that second-line study ends in 2029. Only four years ago Novartis cited consensus sales forecasts for Piqray of $1.3bn by 2025, but the drug’s first-half 2024 revenues fell 7% to just $229m. Roche has some time to take advantage, but inhibitors from Relay, Scorpion and Lilly can’t be ignored.

A tale of two PI3Kα inhibitors

Source: OncologyPipeline & US prescribing information.