Bristol Myers Squibb (BMS) has reported that the Phase III CheckMate-816 clinical trial of Opdivo (nivolumab) met the primary goal in people with resectable stage IB to IIIA non-small cell lung cancer (NSCLC).
Results from a prespecified interim analysis showed that treatment with Opdivo in combination with chemotherapy before surgical procedures demonstrated a clinically meaningful enhancement in event-free survival (EFS).
An inhibitor of programmed death-1 (PD-1) immune checkpoint, Opdivo can modulate the immune system to fight cancer.
The open-label, randomised, multicentre trial analysed Opdivo plus chemotherapy against chemotherapy alone as neoadjuvant therapy in subjects suffering from NSCLS, irrespective of PD-L1 expression.
Pathologic complete response (pCR) and EFS were the trial’s primary goals.
Overall survival, major pathologic response and time to death or distant metastases, were included as secondary goals.
As reported earlier, the combination treatment offered a substantial improvement in pCR.
In the trial, the safety profile of the combination treatment of Opdivo and chemotherapy was in line with the already reported data in NSCLC.
Bristol Myers Squibb vice-president and thoracic cancers development lead Abderrahim Oukessou said: “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.”
On concluding the full analysis of data from the trial, the company plans to submit it to various health agencies.
In September this year, BMS has reported positive three-year data from the CheckMate-743 trial where Opdivo (nivolumab) plus Yervoy (ipilimumab) as first-line therapy provided a lasting survival benefit in patients with unresectable malignant pleural mesothelioma, irrespective of their histology.