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Merck (MRK), Eisai Combo Therapy Fail Two Lung Cancer Studies

Merck MRK and its partner Eisai announced results from two late-stage clinical studies evaluating a combination of their cancer therapies in patients with certain types of metastatic non-small cell lung cancer (“NSCLC”).

Both studies failed to achieve their dual primary endpoints of overall survival (“OS”) and progression free survival (“PFS”).

The LEAP-006 study evaluated the combination of Merck’s Keytruda, Eisai’s Lenvima, pemetrexed and chemotherapy as a first-line treatment for certain adult patients with metastatic, nonsquamous NSCLC. On the other hand, the LEAP-008 study evaluated Keytruda plus Lenvima as a second-line therapy for patients with metastatic NSCLC whose disease progressed on a combination of chemotherapy and anti-PD-1/-L1 immunotherapy.

The LEAP-006 and LEAP-008 studies also did not demonstrate a statistically significant improvement in objective response rate (“ORR”), a key secondary endpoint in both studies.

Neither Merck nor Eisai updated whether the companies will continue to develop the drug in the two NSCLC indications. The full evaluation of data from both studies is ongoing. The companies intend to share the results.

Merck’s shares have lost 4.2% year to date against the industry’s 5.7% growth.

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The Keytruda plus Lenvima combination is currently approved in the United States, Europe, Japan and other countries for treating advanced renal cell carcinoma (“RCC”) and certain types of advanced endometrial carcinoma.

Merck and Eisai are studying this combination through the LEAP clinical program across various tumor types, including hepatocellular carcinoma, head and neck cancer, gastric cancer and esophageal cancer, across multiple clinical studies.

The setbacks in LEAP-006 and LEAP-008 are one of the many setbacks suffered by Merck and Eisai on the Keytruda/Lenvima combination. Last month, both companies announced the closure of the phase III LEAP-010 study on Keytruda plus Lenvima combo as a first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma (“HNSCC”). Data from the study failed to show an overall survival benefit for patients.

In April, Merck and Eisai discontinued another phase III study called LEAP-003, evaluating Keytruda/Lenvima combination for the first-line treatment of adults with unresectable or metastatic melanoma. Patients treated with the combination did not improve OS, one of the study’s dual primary endpoints, versus Keytruda alone.

Alongside the LEAP-003 update, Merck and Eisai also announced that the phase III LEAP-017 study, evaluating Keytruda plus Lenvima for treating patients with unresectable and metastatic colorectal cancer, did not meet its primary endpoint of OS.

Merck and Eisai plan to continue to study the combination of drugs for other indications under the LEAP program.

In a separate press release, Merck, along with partner Seagen SGEN, reported positive top-line results from a late-stage study (KEYNOTE-A39/EV-302) of the combination therapy of Seagen’s Padcev with Keytruda for the treatment of adult patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC). The Seagen/Merck partnered study achieved its co-primary endpoints of OS and PFS.

The FDA approves the Seagen/Merck drug combination for the above indication under the accelerated pathway. The Seagen/Merck conducted KEYNOTE-A39/EV-302 study intends to serve as a confirmatory study seeking to convert the accelerated approval to a full one.

Merck & Co., Inc. Price


Merck & Co., Inc. Price
Merck & Co., Inc. Price

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Zacks Rank & Stocks to Consider

Merck currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks are Annovis Bio ANVS and Novartis NVS, each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

In the past 60 days, estimates for Annovis Bio’s 2023 loss per share have narrowed from $4.89 to $4.38. During the same period, the loss estimates per share for 2024 have improved from $3.18 to $2.77. Year to date, shares of Annovis have lost 26.4%.

Earnings of Annovis Bio beat estimates in three of the last four quarters while missing the mark on one occasion, witnessing an earnings surprise of 13.40% on average. In the last reported quarter, Annovis’ earnings beat estimates by 6.14%.

In the past 30 days, estimates for Novartis’ 2023 earnings per share have risen from $6.81 to $6.92. During the same period, the estimates per share for 2024 increased from $7.32 to $7.52. Year to date, shares of Novartis have risen 11.5%.

Earnings of Novartis beat estimates in each of the trailing four quarters, witnessing an average earnings surprise of 6.56%. In the last reported quarter, Novartis’ earnings beat estimates by 8.93%.

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