- Merck & Co.'s blockbuster cancer drug Keytruda continued to dominate the field, with the company announcing positive results from the Phase 3 KEYNOTE-189 trial in the first-line setting for patients with non-squamous non-small cell lung cancer (NSCLC).
- The trial tested Keytruda in combination with Eli Lilly & Co.'s Alimta and chemotherapy compared with a regimen of Alimta and chemo alone.
- The combo therapy produced "significantly longer" overall survival and progression-free survival than the Alimta/chemo regimen alone.
Merck didn't reveal the specifics of the trial, but did announce that the combination was so effective that an Independent Data Monitoring Committee declared the success at an interim analysis, well ahead of expectations.
The study wasn't expected to report out until next year, but now the full results will be reported at an upcoming medical meeting.
While Merck's Keytruda (pembrolizumab) is not the checkpoint inhibitor leader by revenue — still lagging behind Bristol-Myers Squibb & Company's Opdivo (nivolumab) — the drug has been racking up indications and is quickly gaining ground.
The most important market for any of the PD-1/L1 inhibitors is the NSCLC market due to the large number of patients. So far, Keytruda is the only checkpoint inhibitor approved in the first-line setting.
Meanwhile, Opdivo and other anti-PD-1/L1s have shown mixed results in the space. Bristol-Myers, Roche and AstraZeneca plc all have clinical trials ongoing testing their respective checkpoint inhibitors as a combination treatment.
This latest win could solidify Keytruda as the checkpoint inhibitor of choice in the first-line setting.
With a number of checkpoint inhibitors now approved and flooding the market, questions have arisen about how many of these drugs the market really needs and whether they are interchangeable. So far, Keytruda and Opdivo have taken early leads and seem to be keeping other competitors from gaining significant marketshare. Barring any unexpected shake-ups in the space, it appears the two drugs will remain the checkpoint inhibitor leaders.
Roche has been angling to beat out Merck in this first-line lung setting with its checkpoint inhibitor Tecentriq (atezolizumab), studying the drug in the same patient population. Yet, that study has yet to report out.
"The fact that Merck hit in KN-189 already means Roche won't get that leg up over Merck that was being talked about post IMP-150 (also in 1L lung),” wrote Evercore ISI analyst Umer Raffat in a Jan. 16 note to investors.
The news sent Merck shares up 8.5% in morning trading, while both Roche and Bristol-Myers were off about 4%.
Investors had started to worry about Keytruda in lung cancer after the company had unexpectedly pulled its application for approval from Europe of Keytruda in combination with chemo.
Analysts had speculated that potentially the EMA would not approve the combo based only on Phase 2 results, despite an approval in the U.S.
Merck is expected to resubmit its application to the EMA based on the KEYNOTE-189 results.