Top-line results from the Phase III CheckMate-331 study evaluating Opdivo (nivolumab) versus the current standard of care, topotecan or amrubicin (where approved), in patients with small cell lung cancer (SCLC) who relapsed following platinum-based chemotherapy, did not meet its primary endpoint of overall survival (OS) versus chemotherapy.
The safety profile of Opdivoin this trial was consistent with that observed in previously reported monotherapy studies involving patients with SCLC, said Bristol-Myers Squibb (NYSE: BMY), whose share price edged 0.53% higher to $57.84 despite the disappointing results.
Dr Sabine Maier, development lead, thoracic cancers, at Bristol-Myers Squibb, commented: “Small cell lung cancer is a highly aggressive disease in which significant unmet need remains. We are focused on researching innovative oncology therapies to improve outcomes for patients with lung cancer.”
Bristol-Myers Squibb has a broad development program in thoracic malignancies, including SCLC, non-small cell lung cancer and malignant pleural mesothelioma. As part of this program, the Company is investigating the role of Opdivo plus Yervoy (ipilimumab) and Opdivo monotherapy versus placebo in the frontline setting as a maintenance therapy for patients with SCLC who do not progress on first-line chemotherapy.
In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. It is currently approved in more than 65 countries, including the USA, the European Union, Japan and China. It was also approved in the USA in August this year for the SCLC indication. The drug generated first-half 2018 sales of $3.14 billion.
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