It has the makings of a David and Goliath story: MacroGenics will kick off a trial later this year that will pit its Incyte-partnered anti-PD-1 drug against Merck’s Keytruda—the first drug of its class to win approval—in patients with head and neck cancer.
To be clear, the study’s main objective isn’t to challenge Keytruda with a new PD-1 drug, Evercore ISI analysts Jonathan Miller and Umer Raffat wrote in a note on Wednesday. It’s actually designed to gauge how MacroGenics’ anti-B7-H3 med enoblituzumab fares against standard of care, in combination with its Incyte-partnered PD-1 drug MGA012 and chemotherapy, as well as with MGA012 alone.
But by using Keytruda with chemo as the standard-of-care arm and including another arm that will test MGA012 with chemo, MacroGenics will come out of the trial with a head-to-head battle between a new PD-1-targeting antibody and Merck’s blockbuster Keytruda.
It is, by the analysts' reckoning, the first time a study has done this.
“This trial pits a new PD-1 vs Keytruda, directly compared. To our knowledge, this is the first trial we've found that is attempting this comparison,” they said in the note.
The phase 2 study will recruit 200 patients with head and neck cancer, with 50 patients in each arm, the analysts wrote. It will test enoblituzumab and MGA012 in patients who have not undergone other treatments.
For its part, Keytruda has beat its rival, Opdivo from Bristol-Myers Squibb, to be the first PD-1 med approved for untreated head-and-neck-cancer patients. Both drugs had FDA nods in later-line settings, but Keytruda pulled ahead this year, after posting promising data at last year’s European Society for Medical Oncology annual meeting and snagging a priority review tag from the FDA.