MADRID, Spain—AstraZeneca is still licking its wounds from its July lung-cancer combo flop—and Bristol-Myers Squibb is dreading the possibility of producing a similar result with its own ongoing Opdivo-Yervoy study. But Merck just keeps piling on the positive results from its own victorious approach.
Friday at the European Society for Medical Oncology (ESMO) annual meeting in Madrid, the New Jersey drugmaker rolled out an additional five months’ worth of data from its phase 2 study testing immuno-oncology star Keytruda alongside chemo in first-line lung-cancer patients—and showed that the pairing had maintained the benefits it previously showed.
At a median 18.7 months of follow-up, 56.7% of patents receiving the Keytruda-chemo cocktail had responded, versus just 31.7% of those on chemo alone. The Keytruda-combo arm continued to show it could slash the rate of disease worsening or death by nearly half, too—46%, to be precise—and the risk of death by 41%.
While the Keytruda-chemo combo is already approved for first-line use in the U.S., Merck is still chasing approvals in “a variety of jurisdictions,” including Europe, R&D chief Roger Perlmutter said on July’s second-quarter earnings conference call. And as Bernstein analyst Tim Anderson pointed out in May, “the bar to filing/approval is typically much higher” in Europe than it is in the U.S., increasing the importance of positive overall survival data.
Those data will only help adoption in the U.S., too, where Merck so far has heard “very positive comments” from the physician community since the combo’s May approval, Adam Schechter, Merck’s president of global human health, said on the second-quarter call.
“I would expect that the combination will be used increasingly more often as we move forward,” dismissing the notion that phase 3 data could be needed to “open the floodgates in terms of broad utilization.”
On the other side of the coin, AstraZeneca is still smarting from July results that showed its alternative approach—pairing PD-L1 med Imfinzi with CTLA4 candidate tremelimumab—didn't outperform solo Imfinzi or chemo at staving off lung cancer progression. Bristol-Myers Squibb is trialing a similar pairing of its Opdivo and CTLA4 med Yervoy, with results likely to arrive early next year, while Roche is following in Merck’s footsteps with a Tecentriq-chemo combo.