Roche Announces Second Interim Analysis Results of TIGIT Monoclonal Antibody Tiragolumab Combined with PD-L1 Inhibitor Tecentriq in First-Line NSCLC

On August 23, Roche announced the results of the second interim analysis of the Phase III SKYSCRAPER-01 study. The study aims to evaluate the efficacy of TIGIT monoclonal antibody tiragolumab in combination with Tecentriq (atezolizumab) versus Tecentriq monotherapy as a first-line treatment for patients with PD-L1 high expression, locally advanced or metastatic non-small cell lung cancer (NSCLC).

At the time of the second interim analysis, the interim results for the primary endpoint of overall survival (OS) were not yet mature. The median OS in the tiragolumab plus Tecentriq group was estimated to be 22.9 months [95% CI: 17.5, NE], while the median OS in the Tecentriq monotherapy group was estimated to be 16.7 months [95% CI: 14.6, 20.2], 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. The data showed that tiragolumab combined with Tecentriq was well tolerated, with no new safety signals identified.

The SKYSCRAPER-01 study is ongoing, and neither the patients nor the investigators have been unblinded. Roche stated that it will continue this study until the final analysis of overall survival. All other studies in the Tiragolumab program will continue as planned.

• Failed to reach the primary endpoint of PFS

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