Merck clears PFS endpoint in confirmatory trial for Keytruda in classical Hodgkin lymphoma
Classical Hodgkin lymphoma was the first blood cancer that Merck’s Keytruda was approved to treat. Three years after that OK arrived — kicking off a spate of new indications for the star PD-1 inhibitor — the company finally has some solid evidence of its effect.
Building on the overall response rates that convinced FDA regulars to hand down an accelerated approval in March 2017, Merck said Keytruda hit a co-primary endpoint on progression-free survival in the Phase III confirmatory trial.
The update comes from an interim analysis comparing Keytruda to Adcetris, an antibody-drug conjugate from Seattle Genetics, among patients with relapsed or refractory cHL who have received three or more lines of therapy.
“Patients with classical Hodgkin lymphoma are generally young and when they do not achieve remission following standard treatment, their cancer is challenging to treat,” Jonathan Cheng, VP of oncology clinical research at Merck Research Laboratories, said in a statement.
The study, KEYNOTE-204, will continue to evaluate the other co-primary endpoint of overall survival. Results will be presented at an upcoming medical meeting.
Merck included the monotherapy regimen in fourth-line treatment of cHL in its application for a new Keytruda dosing schedule of every six weeks — to which the FDA responded with a complete response letter days ago. But Mizuho analyst Mara Goldstein characterized it as one of the “less meaningful indications” compared to core combo franchises in non-small cell lung cancer and renal cell carcinoma in driving sales of $20 billion by 2024 as she has previously estimated.
The company has two other cHL trials for Keytruda under way, including combination tests with chemo among children and young adults newly diagnosed with the disease (KEYNOTE-667), and with Affimed’s AFM13 in the post-Adcetris setting (KEYNOTE-206).
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