CheckMate -9LA, a Phase 3 Trial Evaluating Opdivo (nivolumab) Plus Low-Dose Yervoy (ipilimumab) Combined with Chemotherapy, Meets Primary Endpoint Demonstrating Superior Overall Survival Compared to Chemotherapy Alone in First-Line Lung Cancer
Bristol-Myers Squibb Company (NYSE: BMY) today announced that CheckMate -9LA, a pivotal Phase 3 trial evaluating Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) given concomitantly with two cycles of chemotherapy for the first-line treatment of advanced non-small cell lung cancer (NSCLC), met its primary endpoint of superior overall survival (OS) at a pre-specified interim analysis. The comparator in this study was chemotherapy alone for up to four cycles followed by optional maintenance therapy. The safety profile of Opdivo plus low-dose Yervoy and two cycles of chemotherapy in CheckMate -9LA was reflective of the known safety profiles of the immunotherapy and chemotherapy components in first-line NSCLC.
“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,” said Fouad Namouni, M.D., head, Oncology Development, Bristol-Myers Squibb. “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 company will complete a full evaluation of the CheckMate -9LA data and looks forward to presenting these results at an upcoming congress and sharing them with regulatory authorities.
About CheckMate -9LA
CheckMate -9LA is an open-label, multi-center, randomized phase 3 trial evaluating Opdivo (360 mg Q3W) plus Yervoy (1 mg/kg Q6W) combined with chemotherapy (two cycles) compared to chemotherapy alone (up to four cycles followed by optional pemetrexed maintenance therapy if eligible) as a first-line treatment in patients with advanced NSCLC regardless of PD-L1 expression and histology. Patients in the experimental arm were treated for up to two years or until disease progression or unacceptable toxicity. Patients in the control arm were treated with up to four cycles of chemotherapy and optional pemetrexed maintenance (if eligible) until disease progression or toxicity. The primary endpoint of the trial was OS in the intent to treat population. Secondary endpoints included progression-free survival (PFS), overall response rate (ORR), and efficacy measures according to biomarkers.