Genentech, a member of the Roche Group, announced that the phase II/III SKYSCRAPER-06 study evaluating tiragolumab plus Tecentriq (atezolizumab) and chemotherapy versus pembrolizumab and chemotherapy as an initial treatment for people with previously untreated, locally advanced unresectable or metastatic non-squamous non-small cell lung cancer, did not meet its primary endpoints of progression-free survival at its primary analysis with a hazard ratio of 1.27 [95% CI: 1.02,1.57] and overall survival at its first interim analysis with a HR of 1.33 [95% CI: 1.02, 1.73], which was immature.
FDA has accepted a New Drug Application for zipalertinib for the treatment of patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy, with or without amivantamab. The Prescription Drug User Fee Act target action date is Feb. 27, 2027.
