COPENHAGEN, Denmark--Regulatory authorities are already evaluating Bristol-Myers Squibb’s Opdivo in head and neck cancer, based on impressive survival rates posted in a Phase III study. In the meantime, though, Bristol has gone back through through that study data to show its med topped the standards of care in quality-of-life metrics, too.
In the CheckMate-141 study, second-line patients with recurrent or metastatic squamous cell carcinoma of the head and neck reported stabilized symptoms and functioning--including physical and social functioning--during the first 15 weeks of Opdivo treatment, Bristol said Sunday at the ESMO 2016 Congress.
On the flip side, those study participants taking methotrexate, docetaxel or Eli Lilly’s Erbitux saw their quality of life significantly worsen over the same time period.
Opdivo also significantly delayed the worsening of symptoms such as fatigue and insomnia when compared with that trio of treatments.
The data are important, considering the “debilitating physiological effects” that often pile onto the “emotional and social challenges brought on by the condition despite current treatment options,” Kevin Harrington, a professor at the Institute of Cancer Research in London, said in a statement.
And they could also prove useful considering the edge Bristol’s rival, Merck, already has in head and neck cancer with Opdivo archrival Keytruda. That med won the FDA’s green light in August after achieving a 16% response rate in Merck’s Keynote-012 study; 82% of those patients were still responding to the therapy at the 6-month mark.
But BMS may not be that far behind. Regulators are currently weighing its application for a head-and-neck nod, which includes data showing that Opdivo exended the median survival rate of patients to 7.5 months from 5.1 months for the three standards of care. 36% of patients in the study’s Opdivo arm also lived for at least 12 months, results showed.
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