Bristol Myers Squibb takes another late-stage loss for Opdivo-Yervoy combo in head and neck cancer
Bristol Myers Squibb has worked overtime to hunt down an edge for its PD-(L)1 blocker Opdivo over rival Keytruda from Merck, including taking a bold combo strategy with CTLA4 inhibitor Yervoy. But in head and neck cancer, the combo keeps dropping duds.
Opdivo plus Yervoy failed to show clinical benefit in extending the lives of first-line patients with recurrent or metastatic squamous cell carcinoma of the head and neck, according to topline results from the Phase III CHECKMATE-651 study revealed Friday.
The trial tested the duo against what’s known as the EXTREME regimen, a first-line combo of Erbitux, cisplatin/carboplatin and fluorouracil, the drugmaker said.
Bristol Myers took a shot at spinning a positive, saying the study data showed a “clear, positive trend towards overall survival” for high expressing PD-L1 positive patients and noting the study’s control arm performed “better than expected based on historical data.”
But it’s a failure, nonetheless, and a missed opportunity to gain ground on Keytruda. In a statement, Abderrahim Oukessou, Bristol Myers’ VP of thoracic cancers and development lead, called the results “disappointing.”
As of now, full results aren’t available, and Bristol Myers said it would conduct a “full evaluation” before allowing the scientific community to assess the damage.
The topline results aren’t all that surprising given Opdivo-Yervoy already flopped a head-to-head study against Opdivo alone in these same patients back in 2019, the first sign the combination could be in for some turbulence. The combo does hold a second-line approval in this indication dating back to 2016 based on a positive OS readout in the CHECKMATE-141 trial.
Opdivo, which sports an approval in the first-line setting dating back to 2016, could also be in trouble in head and neck cancer after drug price watchdog the National Institute for Health and Care Excellence (NICE) telegraphed in January that it had stopped recommending the solo checkpoint inhibitor’s use on England’s NHS.
The drug had previously been available as part of NICE’s Cancer Drug Fund, which allows physicians to apply for use on a case-by-case basis, but investigators found the drug’s clinical benefit profile wasn’t sturdy enough to even endorse limited use.
Meanwhile, Keytruda also sports an approval in that same indication dating to roughly the same time, but has faced less of an uphill climb. Part of the reason is Merck hasn’t chased a combo approval alongside a CTLA4 blocker like Yervoy. The drugmaker has been adamant that not all cancers benefit from the PD-1/CTLA4 combination, effectively throwing cold water on Bristol Myers’ pipeline strategy.