Bristol Myers announces EC approved perioperative regimen of Opdivo

Bristol Myers (BMY) Squibb announced that the European Commission, or EC, has approved the perioperative regimen of neoadjuvant Opdivo, or nivolumab, and chemotherapy followed by surgery and adjuvant Opdivo for the treatment of resectable non-small cell lung cancer, or NSCLC, at high risk of recurrence in adult patients whose tumors have PD-L1 expression greater than or equal to1%. The decision is based on results from the CheckMate -77T study, which evaluated the perioperative regimen of neoadjuvant Opdivo with platinum-doublet chemotherapy followed by surgery and adjuvant Opdivo monotherapy, compared to neoadjuvant platinum-doublet chemotherapy and placebo followed by surgery and adjuvant placebo in adult patients with resectable NSCLC. The trial met its primary endpoint of event-free survival, or EFS, showing that the risk of disease recurrence, progression or death was reduced by 42% in patients treated in the Opdivo arm, compared to the chemotherapy and placebo arm, after a median follow-up of 25.4 months. Furthermore, after 24-months, EFS was observed in 65% of patients in the Opdivo arm, compared to 44% of patients in the chemotherapy and placebo arm. The trial also demonstrated clinically meaningful improvements in the secondary efficacy endpoints of pathologic complete response and major pathologic response.