Merck MRK along with partner Eisai announced data from the phase III LEAP-015 study, which evaluated blockbuster PD-1 inhibitor, Keytruda (pembrolizumab) and Eisai’s TKI inhibitor, Lenvima (lenvatinib) in combination with chemotherapy for treating certain types of gastroesophageal adenocarcinoma.
The LEAP-015 study evaluated Keytruda plus Lenvima in combination with chemotherapy (Keytruda plus Lenvima-based regimen) versus chemotherapy alone for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastroesophageal adenocarcinoma.
The dual primary endpoints of the LEAP-015 study were progression-free survival (“PFS”) and overall survival (“OS”).
At the interim analysis, data from the phase III LEAP-015 study showed that treatment with the Keytruda plus Lenvima-based regimen led to a statistically significant improvement in PFS versus standard-of-care chemotherapy, one of the dual primary endpoints of the study.
However, in the final analysis, the study failed to meet its other primary endpoint of OS.
Also, treatment with the Keytruda plus Lenvima-based regimen demonstrated a statistically significant improvement in objective response rate which was a key secondary endpoint of the LEAP-015 study.
The safety profile of the Keytruda plus Lenvima-based regimen was similar to that seen in previously reported studies.
MRK Stock's Price Performance
In the past year, shares of Merck have lost 21.2% compared with the industry’s decline of 2.2%.
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The Keytruda plus Lenvima combination is currently approved in the United States, Europe, Japan and other countries for treating certain types of advanced endometrial carcinoma and advanced renal cell carcinoma.
Full data from the LEAP-015 study will be presented at an upcoming medical conference.
Merck and Eisai are studying this combination through the LEAP clinical program across various tumor types like hepatocellular carcinoma and esophageal cancer, in multiple clinical studies.
Keytruda: MRK's Biggest Strength
Keytruda is the biggest product in Merck’s portfolio. The drug generated sales of more than $21 billion in the first nine months of 2024. Keytruda, approved for several types of cancer, alone accounts for around 50% of the company’s pharmaceutical sales. The drug has played an instrumental role in driving Merck’s steady revenue growth in the past few years.
Keytruda’s sales are gaining from rapid uptake across earlier-stage indications, mainly early-stage non-small cell lung cancer (“NSCLC”). Continued strong momentum in metastatic indications is also boosting sales growth. The company expects continued growth from Keytruda, particularly in early lung cancer.
This is one of the most successful cancer drugs ever and is considered a market leader for treating NSCLC. However, Keytruda patents are set to lose exclusivity post 2028.
Merck is working on different strategies to drive Keytruda's long-term growth. These include innovative immuno-oncology combinations, including Keytruda with TIGIT, LAG3 and CTLA-4 inhibitors. The company is also developing a subcutaneous formulation of Keytruda that can extend its patent life.
MRK's Zacks Rank & Stocks to Consider
Merck currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Voyager Therapeutics, Inc. VYGR, Harmony Biosciences Holdings, Inc. HRMY and Castle Biosciences, Inc. CSTL, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Voyager Therapeutics’ loss per share have narrowed from $1.72 to $1.58 for 2025. In the past year, shares of VYGR have plunged 26.1%.
VYGR’s earnings beat estimates in each of the trailing four quarters, the average surprise being 120.87%.
In the past 60 days, estimates for Harmony Biosciences’ earnings per share have increased from $2.64 to $3.22 for 2025. In the past year, shares of HRMY have rallied 17.8%.
HRMY’s earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 147.24%.
In the past 60 days, estimates for Castle Biosciences’ loss per share have narrowed from $1.88 to $1.70 for 2025. In the past year, shares of CSTL have increased 7%.
CSTL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 172.72%.
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