Roche has provided the latest update on its Phase III SKYSCRAPER-01 trial, which examines the efficacy of combining tiragolumab with Tecentriq (atezolizumab) versus Tecentriq alone in patients with PD-L1-high, locally advanced, or metastatic non-small cell lung cancer (NSCLC).
The SKYSCRAPER-01 study is an international Phase III, randomized, double-blind trial assessing the combination of tiragolumab and Tecentriq versus Tecentriq alone in 534 patients suffering from untreated, locally advanced, unresectable, or metastatic NSCLC with high PD-L1 levels. Participants were assigned to receive either tiragolumab plus Tecentriq or a placebo with Tecentriq in a 1:1 ratio, continuing until disease progression, the perceived loss of clinical benefit, or unacceptable toxicity emerged. The trial did not meet the primary endpoint of overall survival by its conclusion. The safety results were consistent with previous observations upon extended follow-up, and no new safety concerns were flagged. Detailed findings will be showcased at an upcoming medical conference in 2025.
Roche remains committed to regularly assessing its trial programs to evaluate the need for adjustments to ensure ongoing research efficacy. This program will also be reviewed under this framework, with further Phase III data across diverse settings or cancer types anticipated in the next year.
Tiragolumab is an investigational immune checkpoint inhibitor, uniquely incorporating an intact Fc region. It specifically targets TIGIT, a new inhibitory immune checkpoint that tampers with the body’s cancer immunity response.
Tecentriq, a monoclonal antibody, functions by binding to the PD-L1 protein. It attaches to PD-L1 found on tumor cells and immune cells infiltrating tumors, inhibiting its interaction with PD-1 and B7.1 receptors. This blockage aims to reactivate T cells, though Tecentriq might also affect normal cells.
Rooted in Basel, Switzerland since 1896 as a pioneer in the industrial production of branded treatments, Roche has evolved to become the leading biotechnology firm and a frontrunner in in-vitro diagnostics. The company is passionately dedicated to scientific excellence, focusing on devising medical solutions and diagnostics aimed at enhancing and saving human lives across the globe.