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Keynote-598, the first-line combined lung cancer trial that failed but was truly a win for Merck & Co, showed Bristol Myers Squibb’s Yervoy didn’t add anything to Keytruda beyond toxicity . At today’s World Lung conference, full data revealed the victory over Bristol that this represents.
Numerically, median overall survival and progression-free survival in the first-line NSCLC trial were both better with Keytruda alone than with the Yervoy combo. The Yervoy arm had more than twice as many treatment-related serious adverse events as Keytruda monotherapy, and the addition of the drug Bristol resulted in the deaths of seven patients.
Of course, Bristol won’t give up easily, and he already has Opdivo plus Yervoy’s endorsement in some frontline NSCLC settings. But, knowing the Keynote-598 data, doctors seem unlikely to achieve the combo of preference over Keytruda alone. In the NSCLC, Merck’s drug is approved in ≥ 1% PD-L1 expressors, and in all arrivals as part of a chemo combo.
Not the whole story?
One argument Bristol could make is that median survival numbers don’t tell the whole story. Dr Martin Reck of the Grosshansdorf Lung Clinic, lead author of Keynote-598, said Evaluate Vantage that a Yervoy effect could still appear late in the survival curves and that a longer follow-up was necessary to see if there was such a late benefit.
Dr Reck’s perspective is important as he was also a principal investigator of the Checkmate-9LA Opdivo / Yervoy / chemo combo trial, and a member of the steering committee of Checkmate-227, whose controversial sub-analysis led to the approval of Bristol combo in PD-Expressors L1 ≥ 1%.
However, for now, the survival curves speak loud and clear, with Keytruda monotherapy numerically better than combo at virtually all times.
Dr Reck pointed out that “598 had been arrested for futility and of course there was no statistical advantage for Keytruda alone. “We cannot argue that [Yervoy adds] a deleterious [survival] effect, ”he said, speculating that the combo result looked worse due to additional toxicity, which led to some reduction in the intensity of the treatment.
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