Genentech provides update on SKYSCRAPER-01 study

Genentech, a member of Roche, has been made aware of an inadvertent disclosure of the second interim analysis of the Phase III SKYSCRAPER-01 study, evaluating the investigational anti-TIGIT immunotherapy tiragolumab plus Tecentriq versus Tecentriq alone as an initial treatment for people with PD-L1-high locally advanced or metastatic non-small cell lung cancer, or NSCLC. SKYSCRAPER-01 is ongoing and the study remains blinded to patients and investigators. The company is continuing the study until the final analysis for overall survival. All other studies in the tiragolumab program will continue as planned. The interim results for the primary endpoint of overall survival were not mature at the time of the second interim analysis, with median overall survival estimates of 22.9 months in the tiragolumab plus Tecentriq arm, and 16.7 months in the Tecentriq monotherapy arm, yielding a hazard ratio, or HR, of 0.81. This second interim analysis took place in February and was based on a data cut-off in November 2022, with a median follow-up of 15.5 months. The data showed that tiragolumab plus Tecentriq was well-tolerated and no new safety signals were identified when adding tiragolumab to Tecentriq.