Chasing Roche, Merck talks up subcutaneous Keytruda ahead of phase 3 data drop

Merck has talked up the value of its subcutaneous version of Keytruda, arguing that the investigational therapy will increase access to treatment by untethering patients from infusion centers. 

Roche has taken the lead in the race to bring a subcutaneous immune checkpoint inhibitor to market in the U.S., but Merck, which dominates the existing market for intravenous infusions, and others are giving chase. A phase 3 clinical trial of Merck’s subcutaneous prospect in lung cancer is scheduled to reach its primary completion date next month.

Ahead of that milestone, Dean Li, president of Merck Research Laboratories, used the J.P. Morgan Healthcare Conference to make the case for switching from intravenous to subcutaneous administration.

“I think about it as scientific innovation that drives access to a life-saving medicine. Especially in the early stage, you have patients [who] don't want to be tethered. They can't be tethered to an infusion center. If you can remove that for them, you will increase access not just in the cities, but in the world, throughout the United States, but in other countries. So this is [an] important innovation,” Li said.

Li acknowledged that “there’s some debate” about subcutaneous checkpoint inhibitors. Today, Keytruda is given as a 30-minute infusion every three or six weeks. In some indications, the monoclonal antibody is used in combination with other treatments.

If a patient needs to visit an infusion center to receive another treatment, the impact of switching to a subcutaneous checkpoint inhibitor could be negated. However, Li thinks subcutaneous Keytruda will still have value in that scenario. 

“I believe that even when you have an infusion medicine plus infusion Keytruda, if I change it to subcu, I can really, really limit the time that you spend in an infusion center and also stage it in the quite correct sequence depending on the sequencing of other drugs,” Li said.

The push to bring a subcutaneous version of Keytruda to market comes as Merck prepares for the loss of exclusivity on the intravenous formulation in 2028. At that point, biosimilar companies will be able to sell copies of Keytruda, creating an incentive for Merck to differentiate its drug and establish new intellectual property.