Shock for BMS as Opdivo misses goal in late-stage lung cancer trial
pharmafile | August 5, 2016 | News story | Research and Development, Sales and Marketing | BMS, Bristol-Myers Squibb, Checkmate, lung cancer, opdivo
Bristol-Myers Squibb has announced that its much heralded cancer therapy, Opdivo (nivolumab), failed to meet its primary endpoint of progression-free survival as a monotherapy in patients with non-small cell lung cancer.
In the CheckMate-026 trial, in those whose tumours expressed PD-L1 greater than or equal to 5%, 541 patients were randomised to receive either Opdivo or trial investigator’s choice chemotherapy until disease progression, unacceptable toxicity, or completion of six cycles.
This is the first major setback for BMS’s wonder drug which has consistently performed well in numerous cancer types, such as melanoma, lung cancer and head and neck cancer, and has been approved in a variety of indications in the US and EU..
Giovanni Caforio, CEO at BMS, says: “Opdivo has become a foundational treatment that is transforming cancer care across multiple tumour types. While we are disappointed CheckMate-026 did not meet its primary endpoint in this broad patient population, we remain committed to improving patient outcomes through our comprehensive development program, including the ongoing Phase III CheckMate-227 study exploring the potential of the combination of Opdivo plus Yervoy for PD-L1 positive patients, and Opdivo plus Yervoy, or Opdivo plus chemotherapy in PD-L1 negative patients.”
At the time of writing, stock has fallen over 15% in pre-market trading for BMS, with the company’s market cap set to take a hit as high as $20 billion when the market opens.
Sean Murray
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