Merck’s cancer immunotherapy Keytruda beat out standard of care chemotherapy in extending time without worsening symptoms and overall survival among patients with previously untreated non-small cell lung cancer (NSCLC), the company said Thursday.
After reviewing the positive results, an independent data monitoring committee recommended halting Keytruda’s Phase 3 trial ahead of schedule.
These results mark the first time a checkpoint inhibitor has been proven more effective than standard of care in a first-line setting, according to The Street.
Merck has been battling rival Bristol-Myers Squibb in the immuno-oncology space. Bristol-Myers’ Opdivo, another anti-PD1 checkpoint inhibitor, has so far jumped out to an early lead in both global sales and number of indications.
Both Keytruda and Opdivo are already approved for treatment of metastic NSCLC, but only after patients’ symptoms progress after platinum-based chemotherapy. The results announced by Merck likely position Keytruda for approval as a first-line treatment of the lung cancer.
“We believe that the KEYNOTE-024 results have the potential to change the therapeutic paradigm in first-line treatment of non-small-cell lung cancer,” said Roger Perlmutter, president at Merck Research Laboratories.
But Bristol-Myers is close behind and is expected to announce results of its own study testing Opdivo in a first-line setting later this year.
Roche has also entered the race, with its anti-PDL1 drug Tecentriq recently winning approval for the treatment of bladder cancer. The FDA in April granted the drug drug priority review status for second-line treatment of NSCLC, with a target action date of October 19.
In Merck’s Phase 3 study, Keytruda was tested in 305 patients whose tumors expressed high levels of PD-L1, based on a tumor proportion score of 50% or higher.
While details in the announcement were sparse, Merck indicated it would share the data with regulators and would present further information at an upcoming medical meeting.
By Ned Pagliarulo | June 16, 2016