In the phase III CheckMate-77T trial evaluating the perioperative regimen of neoadjuvant Opdivo (nivolumab) with chemotherapy followed by surgery and adjuvant Opdivo in patients with resectable stage 2A to 3B non-small cell lung cancer, the perioperative regimen showed a statistically significant and clinically meaningful improvement in the primary efficacy endpoint of event-free survival as assessed by Blinded Independent Central Review compared to neoadjuvant chemotherapy and placebo followed by surgery and adjuvant placebo.
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.
