Roche Reports Positive OS Trend with Tiragolumab Combination in Phase 3 SKYSCRAPER-01 Trial for PD-L1-High NSCLC

▎WuXi

Edited by Kant Content Team

Recently, Genentech, a subsidiary of Roche, announced the results of the second interim analysis of its phase 3 trial SKYSCRAPER-01. The trial evaluates the efficacy and safety of its investigational TIGIT-targeted antibody tiragolumab in combination with the PD-L1 inhibitor Tecentriq (atezolizumab) compared to Tecentriq alone, as a first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with high PD-L1 expression.The preliminary analysis results of the trial showed that the overall survival (OS) of patients using the combination therapy presented an improving trend, but the data were not yet mature., without reaching statistical significance. Genentech will continue the trial until the final OS analysis is completed, and other tiragolumab-related trials will proceed as originally planned.

Tiragolumab is a novel immune checkpoint inhibitor, a monoclonal antibody that targets TIGIT and has a complete Fc region. TIGIT is a novel inhibitory immune checkpoint, primarily expressed on the surface of T cells and natural killer (NK) cells, which can suppress the body's immune response to cancer.The TIGIT pathway complements the PD-L1/PD-1 pathway, so dual blockade with tiragolumab and Tecentriq may help overcome immune suppression and restore immune response.

SKYSCRAPER-01 is a global Phase 3, randomized, double-blind study evaluating the efficacy and safety of tiragolumab in combination with Tecentriq compared to Tecentriq monotherapy in 534 patients with locally advanced, unresectable, or metastatic non-small cell lung cancer whose tumors highly express PD-L1. The co-primary endpoints are overall survival and progression-free survival (PFS) in the primary analysis.

At the time of the second interim analysis, the interim data for the primary endpoint of overall survival had not yet matured, andThe estimated median overall survival for patients treated with tiragolumab in combination with Tecentriq was 22.9 months (95% CI: 17.5-NE), compared to 16.7 months (95% CI: 14.6-20.2) for the Tecentriq monotherapy group, with a hazard ratio (HR) of 0.81 (95% CI: 0.63-1.03).The second interim analysis was conducted in February 2023, with a data cutoff date of November 2022 and a median follow-up time of 15.5 months.

Data show that the combination therapy was well tolerated, with no new safety signals detected.