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Roche reports interim results for phase-III Skycraper-01 study in PD-L1-high metastatic non-small cell lung cancer

The study evaluating Tiragolumab plus Tecentriq did not meet its co-primary endpoint of progression-free survival

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Roche today announced results from its phase-III Skyscraper-01 study, evaluating the investigational anti-TIGIT immunotherapy Tiragolumab plus Tecentriq (atezolizumab) versus Tecentriq alone as an initial (first-line) treatment for people with PD-L1-high locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC), a company statement said.

The study did not meet its co-primary endpoint of progression-free survival. At this first analysis, the other co-primary endpoint of overall survival was immature, and the study will continue until the next planned analysis. A numerical improvement was observed in both co-primary endpoints. Data suggest that Tiragolumab plus Tecentriq was well-tolerated and no new safety signals were identified when adding Tiragolumab. Further analyses of these results are ongoing and data will be presented at an upcoming medical meeting, the statement added.

“While these results are not what we hoped for in our first analysis, we look forward to seeing mature overall survival for this study to determine next steps. We continue to believe that TIGIT may have a role in cancer treatment and we will share additional results from our Tiragolumab programme as they emerge,” said Levi Garraway, MD, PhD, Chief Medical Officer and Head, Global Product Development, Roche.

The Tiragolumab programme continues to explore advances in multiple clinical trials to build on Tecentriq, expand into earlier stages of disease, and seeks to provide new treatment options in advanced and difficult-to-treat cancers with high unmet medical need, the statement concluded.

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