One door has closed but another has opened for Bristol-Myers Squibb’s (NYSE:BMY) Opdivo. While data presented at Esmo confirmed its disappointing showing in first-line lung cancer, the company can console itself with impressive results in head and neck cancer.
The data from the Checkmate-141 study could add yet another new indication to Opdivo’s already impressive roster (see table below). Merck & Co’s (NYSE:MRK) Keytruda is already approved in head and neck cancer, but Bristol claims that Opdivo is the first and only PD-1 inhibitor to show an overall survival benefit over standard of care.
In fact, the one-year overall survival rate with Opdivo was more than double that seen with standard therapy, at 36% and 17% respectively.
The improvement in survival was also independent of tumor PD-L1 expression – although there was a suggestion of greater benefit in patients with PD-L1 expression of 1% or more when compared to non-expressers, it did not reach significance.
Opdivo therefore looks on track for approval in the same indication that Keytruda got the nod for in August: recurrent or metastatic squamous cell carcinoma of the head and neck after platinum therapy, regardless of PD-L1 status. A decision from the FDA is expected on November 11.
And with the Keytruda approval based on the surrogate endpoints of objective and complete response rates, Opdivo’s more robust dataset could help it capture market share, if it does get the go-ahead as expected.
Checkmate-141, presented at Esmo yesterday and simultaneously published in the NEJM, compared Opdivo with the investigator’s choice of therapy – methotrexate, docetaxel or cetuximab. Median overall survival, the primary endpoint, was 7.5 months with Opdivo versus 5.1 months in the standard therapy group.
However, head and neck cancer is a smaller indication than first-line non-small cell lung cancer, where Opdivo now faces the prospect of falling behind Keytruda. Merck’s drug stole the show at Esmo with stellar results from Keynote-024 and, to add insult to injury, data from the Checkmate-026 trial of Opdivo in first-line NSCLC turned out to be even worse than expected.
Merck is now in the driving seat in lung cancer for at least the next 12-18 months, Leerink analysts estimate. And the head and neck success did nothing to stop Bristol’s share price opening down 9% today. Bristol has won a small skirmish, but lost the bigger battle.