On October 22, 2019 Bristol-Myers Squibb Company (NYSE: BMY) reported 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 (Press release, Bristol-Myers Squibb, OCT 22, 2019, View Source [SID1234542396]). 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.

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"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.