Combos, Results

Merck’s Keytruda combo wows again, acing PhIII overall survival goal for lung cancer early

Merck’s Keytruda team can chalk up another big win in the race for PD-1/L1 dominance.

Their checkpoint inhibitor added to chemo in a pivotal study delivered “significant” benefits in overall survival as well as progression-free survival among frontline non-small cell lung cancer patients — one of the big prizes in the rivalry over a mega-blockbuster market.

Roger Perlmutter

They are declaring this success at an early, interim point —well ahead of expectations. The final OS readout wasn’t expected until early next year. The new results come just a few months after Merck rattled investors with its decision to yank a European application for Keytruda for frontline use in the face of regulatory resistance to the Phase II data that were being offered.

Merck’s shares moved steadily upwards on the news, jumping 6% by mid-morning with Roche stock skidding 3.7% and Bristol-Myers shares down 2.7% as investors placed their bets.

“The fact that MRK hit in KN-189 already means Roche won’t get that leg up over MRK that was being talked about post IMP-150 (also in 1L lung),” noted Evercore ISI’s Uber Raffat.

Researchers at Merck are sticking with the top-line results for now, with hard numbers on their KEYNOTE-189 study being held for a scientific conference. But this is the first time that a checkpoint study has demonstrated an overall survival benefit for this group.

Their willingness to include OS to the study — which added Keytruda to Eli Lilly’s Alimta — underscored Merck’s confidence in their big cancer drug, which has been making steady advances since Bristol-Myers Squibb stumbled badly last year with a clinical setback that it has yet to recover from. There are now 5 of these PD-1/L1 drugs on the market, with a 6th on the way soon, and hundreds of combination studies like this have been mounted to find the best approach, often centering on chemo or in-house therapies like the CTLA-4 drugs.

Leerink’s Seamus Fernandez says Merck was able to keep its lead today, but the race isn’t over yet. His note:

We see these results as further solidifying MRK’s current lead position in the 1L NSCLC race; however, full data (to be presented at an upcoming meeting) will be necessary to compare with RHHBY’s (NR) IMpower150 trial of Tecentriq (atezolizumab; anti-PD-L1) + Avastin (bevacizumab; anti-VEGF) + chemo, as well as upcoming readouts from BMY’s (OP) CheckMate-227 trial of Opdivo (nivolumab; anti-PD-1) + Yervoy (ipilimumab; anti-CTLA-4) and OS results from AZN’s (MP) MYSTIC trial of Imfinzi (durvalumab; anti-PD-L1) + tremelimuamb (anti-CTLA-4).

“KEYNOTE-189 showed significant improvement in overall survival and progression-free survival for patients receiving Keytruda in the first-line setting in combination with traditional chemotherapy, compared with those receiving chemotherapy alone,” said Merck R&D chief Roger Perlmutter.

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