FDA has granted Breakthrough Therapy designation for CLN-081 for the treatment of patients with locally advanced or metastatic non-small cell lung cancer harboring epidermal growth factor exon 20 insertion mutations who have previously received platinum-based systemic chemotherapy.
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.
