Bristol-Myers Squibb (BMS) has reported that its Phase III CheckMate -9LA clinical trial of Opdivo (nivolumab) and low-dose Yervoy (ipilimumab) combination met the primary endpoint in non-small cell lung cancer (NSCLC) patients.
Opdivo is the company’s programmed death-1 (PD-1) immune checkpoint inhibitor that leverages the body’s immune system to restore anti-tumour response.
BMS designed Yervoy, which is a recombinant, human monoclonal antibody, to bind to the cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) and potentially induce T-cell activation and proliferation.
The open-label, multi-centre, randomised Phase III CheckMate -9LA trial compared 360mg Opdivo plus 1mg/kg Yervoy in combination with chemotherapy to chemotherapy alone as first-line therapy in patients with advanced NSCLC.
Participants received either two cycles of the combination or up to four cycles of only chemotherapy followed by optional maintenance therapy.
The primary endpoint was overall survival (OS), while secondary endpoints included progression-free survival (PFS), overall response rate (ORR) and efficacy measures based on biomarkers.
Data from a pre-specified interim analysis showed that the combination achieved the primary endpoint, demonstrating superiority in overall survival (OS) versus chemotherapy alone.
The safety profile of the combination was observed to be similar to the known safety profiles of the individual components in first-line NSCLC.
Bristol-Myers Squibb Oncology Development head Fouad Namouni said: “We are excited by the CheckMate -9LA results, which demonstrate the potential of Opdivo plus low-dose Yervoy to provide a survival benefit to patients with non-small cell lung cancer in the first-line setting when administered concomitantly with a limited course of chemotherapy.
“These results build on the benefit the combination of Opdivo plus Yervoy has previously shown in first-line melanoma, renal cell carcinoma and most recently lung cancer, and may provide a new therapeutic option for patients.”
The Opdivo and Yervoy combination has approval in more than 50 countries to treat patients with metastatic melanoma.