Bristol Myers Squibb's Opdivo and Yervoy combo falls short in first-line squamous head and neck cancer

In combination with Yervoy, Bristol Myers Squibb's Opdivo has won approval against several indications. But not so against SCCHC. (Fierce Pharma)

Solving squamous cell carcinoma of the head and neck has been a tough nut to crack, even for pharmaceutical companies with leading drugs and significant R&D muscle.

Case in point: Bristol Myers Squibb’s phase 3 trial measuring the efficacy and safety of Opdivo and Yervoy in platinum-eligible patients with recurrent or metastatic SCCHC. In the study, pitting the drugs against the Extreme treatment regimen in first-line SCCHC, Opdivo and Yervoy failed to show a significant statistical edge.

As a monotherapy for adults with recurrent or metastatic SCCHN after platinum-based therapy, Opdivo earned approval in Europe and the United States in 2016. But in the recent frontline study, Opdivo and Yervoy couldn’t top the Extreme formula of cetuximab, fluorouracil and cisplatin/carboplatin.

“Opdivo plus Yervoy showed a positive overall survival trend relative to Extreme … despite the control arm performing better than expected based on historical data,” Abderrahim Oukessou, BMS’s thoracic cancers chief said in a release. “We remain committed to advancing research and supporting patients with this difficult-to-treat cancer.”

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There are few options for the cancer, which has vexed many of the top companies. Last year, Merck KGaA and Pfizer’s Bavencio flopped against SCCHC in the Javelin trial.

Meanwhile, the Opdivo and Yervoy combo has demonstrated positive data in five different other tumors, including non-small cell lung cancer, metastatic melanoma, advanced renal cell carcinoma, malignant pleural mesothelioma and esophageal squamous cell carcinoma.

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BMS' checkpoint inhibitor Opdivo launched in 2014, right around the same time that Merck & Co.'s rival Keytruda hit the scene. But the BMS drug hasn't been able to keep pace with its rival, which generated $14.4 billion globally billion last year. Opdivo generated just shy of $7 billion last year.