- Merck is focusing on combination trials and expanding into new markets to keep momentum going for its most promising drug, Keytruda (pembrolizumab), the company said Thursday during a fourth quarter earnings call.
- Japan, one of the largest pharmaceutical markets in the world, was a particularly bright spot for Merck. While the country had already approved Keytruda for treatment melanoma, it also greenlit the drug for two new indications — first- and second-line treatment of a specific population of non-small cell lung cancer (NSCLC) patients during the fourth quarter.
- As such, the company expects Japanese sales to ramp up ex-U.S. sales, which totaled $172 million during the fourth quarter. Keytruda brought in an additional $311 million in U.S. revenue, of which about 40% came from treating melanoma, 30% from treating lung cancer, 15% from treating head and neck cancer and the remainder coming from additional indications.
"I've said before that Keytruda is changing the landscape of cancer treatment, representing a fourth pillar, if you will, beyond surgery, radiation therapy and traditional chemotherapy that provides hope for further progress in the treatment of malignant disease," Roger Perlmutter, president of Merck Research Laboratories, said during an earnings call Thursday.
Investors pressed Merck on combination therapies, which many view as the next step in immuno-oncology. The big pharma has expressed its interest in combinations for Keytruda before, and submitted an application in mid-January for approval of the drug administered with chemotherapy. The company also has a robust number of combo clinical trials underway, most notably KEYNOTE-189, a Phase 3 study meant to support that recent filing.
Merck attempted to quell concerns that physicians might not adopt the Keytruda and chemotherapy combination given the small patient population of the study that preceded the treatment's filing. By comparison, Roche's late-stage IMpower 150 study, which tests the competing Tecentriq (Atezolizumab) in combination with chemotherapy, has an enrollment of 1,200 and is expected to roll out results around the same time as KEYNOTE-189.
"From what we can tell, physicians will be much more apt to use the combination in patients that they deem to be relatively healthy," Merck's President of Global Human Health Adam Schechter said in response to the former issue. "They're going to evaluate this patient by patient and see where they believe that the combination of the two would outweigh potential side effects and so on."
Perlmutter added that he doesn't expect physicians to wait for Phase 3 readouts to start recommending his company's combination therapy, should it get approved, due to the high need.
In any case, Merck said combination therapies will continue to be prominent both for the company and for the sector.
"My expectation is that, with time, we will see that treatment regimens are more and more personalized," Perlmutter said. "I do not expect that one size will fit all here and that every cancer patient will receive the same combination, whether it's chemotherapy or immunological manipulation."