Bristol Myers Squibb (BMS) has announced that its PD-1 inhibitor Opdivo (nivolumab) plus chemotherapy improved event-free survival in a Phase III trial in patients with resectable non-small cell lung cancer (NSCLC).
According to BMS, in a prespecified interim analysis of the CheckMate-816 trial, Opdivo plus chemotherapy demonstrated a ‘statistically significant and clinically meaningful improvement’ in event-free survival compared to chemotherapy alone in the neoadjuvant setting.
Previously, the immunotherapy combination showed a significant improvement of pathological complete response – the trials additional primary endpoint.
BMS added that it will seek to complete a full evaluation of the available data and is also planning to share the detailed results at an undisclosed, upcoming medical conference. The company will also share the results with health authorities, BMS said in a statement.
“CheckMate-816 is the first Phase III trial with an immunotherapy-based combination to demonstrate a statistically significant and clinically meaningful benefit as a neoadjuvant treatment for patients with non-metastatic non-small cell lung cancer. The combination of Opdivo plus chemotherapy first showed a statistically significant improvement in pathologic complete response rate without impacting surgical outcomes and has now extended the time patients live free of disease progression, recurrence or death,” said Abderrahim Oukessou, vice president, thoracic cancers development lead, BMS.
“The event-free survival data from CheckMate -816 strengthen the evidence for the potential of Opdivo-based therapies to improve long-term clinical outcomes when used in the earlier stages of non-metastatic cancers,” he added.