Roche claims an Itovebi breast cancer survival benefit

Roche’s PI3Kα inhibitor Itovebi already has an edge over Novartis’s similarly acting Piqray, with a first-line FDA approval, and on Monday Roche also claimed a “statistically significant and clinically meaningful” overall survival benefit with its drug. Full OS results from the Inavo-120 trial, in first-line ER-positive HER2-negative breast cancer that’s progressed after adjuvant endocrine therapy, are being saved for a future medical meeting. But a previous OS analysis, although immature, found a trend towards a benefit with an Itovebi/Ibrance/Faslodex triplet versus Ibrance/Faslodex alone, with a hazard ratio of 0.64. Itovebi’s approval was based on PFS data from the same trial. The OS results could help Roche towards its ambition of $2bn Itovebi peak sales; pivotal studies in other settings are also ongoing. However, the PI3Kα inhibitor field has moved on: while Itovebi and Piqray both hit the wild-type and mutant forms, other groups are developing molecules specific for mutated PI3Kα in the hope that these could be less toxic. Players here include Relay and Lilly, which already had its own PI3Kα efforts, but just bought another major contender, Scorpion. Roche, which claims that Itovebi can also degrade mutant PI3Kα, will have to make its head start count.

Phase 3 trials of Itovebi in PIK3CAm breast cancer

Source: OncologyPipeline & clinicaltrials.gov.