Roche’s Skyscraper crumbles

One of the biggest oncology long shots of 2024 has turned out to be a damp squib: Roche’s Skyscraper-01 trial of its TIGIT hopeful tiragolumab in first-line NSCLC has failed its final overall survival analysis. The result follows the leak of a positive interim data cut last year, which found an OS hazard ratio of 0.81. The latest news raises questions about whether the results meaningfully deteriorated or whether they just failed to clear the (unknown) statistical bar; early censoring might also have flattered the interim result. Skyscraper-01 had been much delayed: the final analysis was pushed back from late 2023 to early 2024, then to the second half of this year, presumably because results were accruing more slowly than expected. The latest disappointment comes after a long line of TIGIT failures, not least from Roche itself: following July’s blow-up of Skyscraper-06 the Swiss group discontinued a couple more Skyscraper studies. There are still a few more to read out, although for Roche to have rushed into such a massive programme looks foolish. Others that have clamoured to get on the TIGIT bandwagon, including Arcus/Gilead, GSK/iTeos, Merck & Co and AstraZeneca, now face an even more nervous time.

Roche’s phase 2 & 3 Skyscraper studies

Source: OncologyPipeline & clinicaltrials.gov.