|Merck R&D chief Roger Perlmutter|
Advantage Merck ($MRK) in the melanoma immunotherapy race. The U.S.-based company says its PD-1 drug Keytruda met its goals in a head-to-head study with Bristol-Myers Squibb's ($BMY) Yervoy (ipilimumab), dealing a blow to that company's growing immunotherapy franchise.
Even better, Keytruda bested Yervoy in previously untreated patients with advanced melanoma, a result that could lead to a bigger market for the Merck med.
Keytruda hit its primary endpoints not only for stalling cancer progression, but for extending patients' lives--so-called overall survival, a key measure for regulators, doctors and payers. Merck stopped the study, called KEYNOTE-006, after trial monitors decided the results were strong enough to prompt a halt.
Currently, Keytruda is approved for patients with advanced melanoma previously treated with Yervoy and, in some patients, another type of drug as well. That second- and third-line status limits the number of patients eligible for the drug.
With solid data on first-line use, Merck could ask the FDA to expand that patient pool--and with recent decisions, the agency has proved willing to decide quickly, provided the survival data is there. Keytruda's rival immunotherapy Opdivo recently won an indication in lung cancer mere days after Bristol-Myers filed for that approval, and the FDA's oncology chief cited its impressive overall survival numbers for the quick move.
Opdivo's lung cancer nod put Bristol-Myers ahead in that field, at least in squamous non-small cell lung cancer (NSCLC) patients. Keytruda is eying an NSCLC indication as well, and given the data at hand, the Merck med may get an FDA approval covering a broader range of patients. That won't happen till later this year, however.
Now, Merck has an edge in melanoma, and it's ready to brag about it. The drug delivered a "statistically significant and clinically meaningful improvement" in overall survival and progression-free survival" compared to Yervoy, the company said in a statement. And in announcing the trial results, R&D chief Roger Perlmutter hinted at possible standard-of-care movement. "Evidence from our clinical program for Keytruda will help to define the appropriate treatment of advanced melanoma," Perlmutter said in the statement.
Next month, we'll get a better idea of how big Keytruda's melanoma advantage is. Full data from the KEYNOTE-006 study will be unveiled at the American Association of Cancer Research meeting in Philadelphia.
- read the Merck release
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