Bristol Myers Squibb (BMS) has shared positive overall survival (OS) results from a late-stage study of its Opdivo (nivolumab) combination in non-small cell lung cancer (NSCLC).
The phase 3 CheckMate-816 study has been evaluating the drug alongside platinum-doublet chemotherapy as a neoadjuvant treatment for adults with resectable cases of the disease.
The final analysis of the trial demonstrated a statistically significant and clinically meaningful improvement in the key secondary endpoint of OS for Opdivo-treated patients compared to those receiving neoadjuvant chemotherapy alone.
The safety profile of the Opdivo combination was also found to be consistent with previously reported studies, with no new safety signals observed.
The results come after CheckMate-816 showed statistical significance in the primary endpoints of event-free survival and pathological complete response, which supported the US approval of Opdivo in this indication in March 2022.
“This is the first and only phase 3 study of a neoadjuvant-only immuno-oncology therapy to show a statistically significant [OS] benefit in patients with resectable NSCLC,” said Dana Walker, vice president, global programme lead, late development, oncology, BMS.
“The final analysis of OS in the CheckMate-816 study underscores the potential of Opdivo in combination with chemotherapy to provide a meaningful survival benefit for patients with resectable NSCLC,” Walker said.
More than 200,000 people are diagnosed with lung cancer in the US every year, with NSCLC accounting for up to 85% of cases.
Opdivo is a programmed death-1 immune checkpoint inhibitor designed to use the body’s own immune system to help restore anti-tumour immune response.
Beyonds its NSCLC indications, the drug holds approvals to treat certain cases of melanoma, pleural mesothelioma, renal cell carcinoma, classical Hodgkin lymphoma, squamous cell carcinoma of the head and neck, and colorectal cancer, among other cancer types.
The latest results come less than two months after an injectable form of Opdivo was approved by the US Food and Drug Administration for most previously approved adult, solid tumour intravenous (IV) Opdivo indications.
It is hoped that the subcutaneous formulation will be more convenient for patients, reducing the steps required for preparation and offering an average administration time of three to five minutes compared to 30 minutes for the drug’s IV form.