Phase III SKYSCRAPER-02 study of RG 6058 + Tecentriq fails to meet primary endpoint in extensive-stage small cell lung cancer.- Genentech/Roche
Genentech/Roche announced that the Phase III SKYSCRAPER-02 study, evaluating the investigational anti-TIGIT immunotherapy RG 6058 (tiragolumab) plus Tecentriq (atezolizumab) and chemotherapy (carboplatin and etoposide) as an initial (first-line) treatment for people with extensive-stage small cell lung cancer (ES-SCLC), did not meet its co-primary endpoint of progression-free survival.
The co-primary endpoint of overall survival was not met at its interim analysis and is unlikely to reach statistical significance at the planned final analysis. Data suggest tiragolumab plus Tecentriq and chemotherapy was well-tolerated and no new safety signals were identified when adding tiragolumab. Data will be presented at an upcoming medical meeting.
SKYSCRAPER-02 is a global Phase III, randomized, placebo-controlled and double-blinded study evaluating tiragolumab plus Tecentriq (atezolizumab) and chemotherapy as an initial (first-line) treatment versus Tecentriq and chemotherapy alone in 490 people with extensive-stage small cell lung cancer. Co-primary endpoints are overall survival (OS) and progression-free survival (PFS) in the primary analysis set (all randomized patients whose cancer had not spread to the brain). Key secondary endpoints include OS and PFS in all randomized patients, and safety.
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