Bristol scores in liver; next up, TIGIT

If the US approval of Opdivo plus Yervoy for first-line liver cancer, granted on Friday 10 days before its PDUFA date, wasn't a huge surprise then two future catalysts in this setting might raise eyebrows. These concern the so far hugely disappointing TIGIT mechanism; next year Roche's Skyscraper-14 study, testing tiragolumab's Tecentriq combo, could yield results, an event that realistically represents the last hope for the Swiss company's anti-TIGIT MAb after its failure in other cancer settings. And a new clinicaltrials.gov listing has revealed that AstraZeneca is next month taking rilvegostomig into the Artemide-HCC01 trial, marking that company's ninth phase 3 study of this bispecific anti-TIGIT x PD-1 MAb. Roche and Astra both have anti-PD-(L)1 combos on the market for first-line liver cancer, in Tecentriq plus Avastin, and Imfinzi plus Imjudo, respectively. Artemide-HCC01 adds an anti-CTLA-4 MAb into the mix, as did Astra's Himalaya study of Imfinzi plus Imjudo, as well as the Bristol Myers Squibb Checkmate-9DW trial that supports Friday's approval. Opdivo monotherapy had failed in this setting in Checkmate-459, but Checkmate-9DW showed robust data, despite the study having been delayed and downsized.

Selected pivotal trials* of immuno-oncology approaches in 1st-line liver cancer

Note: *excludes Asia-only studies. Source: OncologyPipeline.