Officials Provide Update on Phase 3 SKYSCRAPER-01 Study

The phase 3 SKYSCRAPER-01 study did “not reach the primary endpoint of overall survival at the final analysis,” according to an announcement from Genentech, a member of the Roche Group.

The global, randomized, double-blinded study is evaluating tiragolumab plus atezolizumab and comparing the combination to atezolizumab alone for patients with PD-L1-high, locally advanced or metastatic non-small cell lung cancer (NSCLC). The study includes 534 patients who had not received previous treatment. Investigators randomized patients 1:1 to receive tiragolumab plus atezolizumab or placebo plus atezolizumab until disease progression, loss of clinical benefit, or unacceptable toxicity.

The study showed that the “overall safety profile observed remained consistent with longer follow-up, and no new safety signals were identified,” officials said. The detailed data will be presented at a medical meeting in 2025.

“Genentech continuously reviews its study programs to determine if any adjustments are necessary for the purposes of ongoing research,” officials said in the announcement. “Genentech will apply the same principles to this program, with additional data from phase 3 studies across different settings or tumor types anticipated next year.”

Source: Genentech