Merck and Bayer unveil the data behind their CV ‘success,’ underwhelming the industry
Four months after Merck announced a surprise Phase III success on the heart drug they gave Bayer $1 billion for, the full data is out — and cardiologists, investors and payers are left wondering just how effective the drug really is.
The data, published in the New England Journal of Medicine and announced in the virtual American College of Cardiology meeting, showed that across 5,050 patients, vericiguat led to a 10% reduction in hospitalizations for heart failure. Although that met the primary endpoint — the composite of time until first death or hospitalization for heart failure — it underwhelmed, particularly as the drug did not lead to a statistically significant reduction in death.
The November announcement had left it up in the air if the composite success had been fueled by reductions in hospitalizations, or reductions in death, or both. That announcement had surprised some, given that the drug failed Phase II trials.
“Our KOLs’ modest expectations were met if not missed and investor expectations were definitely missed,” Cowen’s Steve Scala wrote in a note, citing a survey they had done at their investor conference earlier this month. He projected $500 million in peak sales in 2025.
In advance of the virtual conference, SVB Leerink’s Daina Graybosch noted that the cardiovascular market had become murky in recent years. She cited Novartis’s Entresto, a drug that’s been slow to reach patients despite being hailed as a major advance in cardiovascular therapy, and pointed to an obstacle course of reluctant payers, unfamiliar physicians, out-of-pocket costs for patients and looming questions about real-world benefits. Still, with the potential for real-world data, she said the data could Merck might get “a leg up” on the market.
Instead, on Monday, she wrote the data reduced vericiguat’s potential to a “niche” market in those who can’t tolerate parts of the current standard-of-care. Even that, though, was based on data not yet released, including quality of life metrics in a larger set of patients also treated with Entresto.
“MEDACorp cardiologists we spoke with were pleased to have an additional therapeutic option at their disposal, with positive (but not enthusiastic) commentary provided on vericiguat’s incremental benefit,” Graybosch wrote, citing Leerink’s expert network.
Cardiologists who have may have ordinarily debated the results in the hallways of a Chicago hotel instead discussed them on Twitter, with some praising the hospitalization benefit and noting that, while not statistically significant, the trial did see an absolute decline in deaths. Others described the composite win as “ambiguous.”
Ambiguous results from the VICTORIA trial with #vericiguat in #HFrEF @NEJM: Is your glass half empty or half full? My conclusions below! https://t.co/wiHmjp3unF
1. Nothing in there for mortality reduction. Trial was even overpowered, KM curves are superimposed! pic.twitter.com/pjHnuAWxAg
— Frederik H. Verbrugge (@FH_Verbrugge) March 28, 2020
In a webcast for the American Journal of Managed Care, University of Mississippi College of Medicine chair Javed Butler said the results looked more promising when you considered how short the follow-up was and the particularly high-risk patient population.
“So, if you actually look at the absolute risk reduction, there was about a 4% absolute risk reduction,” he said, “which is the same or better than some of the recent trials that we’ve seen.”
It’s not clear when Merck will file for an NDA, although analysts agreed a submission was likely coming and likely to succeed. Still, with low projected sales and with gefapixant results they Leerink viewed as disappointing earlier this month, Scala wrote that Merck might be in need of some changes.
“MRK’s current strength — thanks to Keytruda and Vaccines — is clear,” he wrote, “but the oxygen for drug manufacturers are pipelines, and MRK’s appears insufficient, raising potential for significant M&A.”