Merck writes off big bet on CETP drug anacetrapib

Merck was the last big player in a race that once featured Eli Lilly, Pfizer and Roche.

Merck, the last big firm standing in the once-hyped CETP field, has opted against filing for approval of anacetrapib. The Big Pharma reached the decision after going over a mixed set of data from its big bet on a phase 3 program.

The door to a filing for approval swung open unexpectedly in June when Merck bucked the trend by reporting its long-running, 30,000-patient study met its primary endpoint. However, hopes that Merck could succeed where Eli Lilly, Pfizer and others had failed were tempered by the small improvement against the main goal, inability to move the needle against secondary endpoints and a safety concern.

That left Merck with a drug that may have snuck past regulators but struggled to win market share. Now, Merck has decided its best option is to cut its losses and move on. 

Virtual Roundtable

ASCO Explained: Expert predictions and takeaways from the world's biggest cancer meeting

Join FiercePharma for our ASCO pre- and post-show webinar series. We'll bring together a panel of experts to preview what to watch for at ASCO. Cancer experts will highlight closely watched data sets to be unveiled at the virtual meeting--and discuss how they could change prescribing patterns. Following the meeting, we’ll do a post-show wrap up to break down the biggest data that came out over the weekend, as well as the implications they could have for prescribers, patients and drugmakers.

“After comprehensive evaluation, we have concluded that the clinical profile for anacetrapib does not support regulatory filings,” Merck's Roger Perlmutter, M.D., Ph.D., said in a statement.

Merck’s move nearly wraps up the drawn-out demise of CETP inhibitors. Setbacks in the clinic for Roche and Pfizer indicated years ago that the field may fail to live up to expectations. But Lilly and Merck forged ahead, driven by a belief those flops stemmed from shortcomings of the drugs, not the idea of CETP inhibitors. Lilly’s belief in that was scuttled by its own clinical data in 2015.

RELATED: Merck may file CETP candidate anacetrapib in unexpected turnaround

Merck got closer than its fallen rivals to getting a CETP inhibitor to the finish line. A statistically significant decline in major coronary events marked a rare late-phase success for the field, but ultimately, the overall data package was too weak for Merck to justify filing for approval.

Merck’s departure from the stage leaves a couple of small companies to fly the flag for CETP inhibitors. DalCor Pharmaceuticals is putting a drug it picked up from Roche, dalcetrapib, through phase 3. And Korea's Chong Kun Dang Pharmaceutical is running a midphase trial of its CETP drug in combination with statins.

Suggested Articles

The FDA named more than two dozen coronavirus antibody tests that should be taken off the market weeks after the agency clamped down on tests.

Inovio CEO J. Joseph Kim is undeterred by short sellers and other detractors who doubt his company can shuttle a COVID-19 DNA vaccine to market.

The machine-learning programs scroll through data to detect hard-to-spot patterns. Yet few have been tested against standard procedures.