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Merck's (MRK) Keytruda, Lenvima Endometrial Cancer Study Fails
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Merck & Co., Inc. (MRK - Free Report) along with partner Eisai announced data from the phase III LEAP-001 study, which evaluated the combination of blockbuster PD-1 inhibitor, Keytruda and Eisai’s TKI inhibitor, Lenvima for the first-line treatment of advanced/recurrent endometrial carcinoma.
The study failed to achieve the dual primary endpoints of overall survival (“OS”) and progression free survival (“PFS”).
The LEAP-001 study evaluated the combination of Keytruda plus Lenvima for the first-line treatment of patients with advanced or recurrent endometrial carcinoma whose disease is mismatch repair proficient (pMMR)/not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)/MSI-H.
The final analysis of the study showed that the Keytruda/Lenvima combination failed to show a sufficient improvement in OS or PS to meet the study’s prespecified statistical criteria for treating certain patients with advanced or recurrent endometrial carcinoma in the first-line setting versus a standard of care, platinum-based chemotherapy doublet (carboplatin plus paclitaxel).
The safety profile of Keytruda plus Lenvima was similar to that observed in earlier reported studies that evaluated the same combination therapy.
Shares of Merck have lost 6.5% year to date against the industry’s 4.3% growth.
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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 following prior systemic therapy and advanced renal cell carcinoma (“RCC”).
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.
Per the company, data from the LEAP-001 study will not affect the currently approved indication for Keytruda plus Lenvima combination as well as the studies that are evaluating the same drug combination.
We note that the latest setback to the LEAP-001 study follows a series of setbacks suffered by Merck and Eisai on the Keytruda/Lenvima combination in the LEAP program.
In September 2023, Merck and Eisai announced data from two late-stage clinical studies that evaluated the Keytruda plus Lenvima combination in patients with certain types of metastatic non-small cell lung cancer (“NSCLC”).
Both studies, LEAP-006 and LEAP-008, failed to achieve their dual primary endpoints of OS and PFS. The studies also did not demonstrate a statistically significant improvement in objective response rate (“ORR”), a key secondary endpoint in both studies.
In August 2023, Merck and Eisai announced the closure of the phase III LEAP-010 study on the 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 the Keytruda/Lenvima combination for the first-line treatment of adults with unresectable or metastatic melanoma. Patients treated with the combination did not demonstrate improvement in 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.
Despite the ongoing setbacks, Merck and Eisai plan to continue to study the Keytruda/Lenvima combination, targeting other difficult-to-treat cancers.
In the past 60 days, estimates for Journey Medical’s 2023 loss per share have narrowed from $1.28 to 16 cents. Meanwhile, loss per share estimates for 2024 have narrowed from 41 cents to 35 cents. Year to date, shares of DERM have surged 203.1%.
Earnings of Journey Medical beat estimates in one of the last four quarters while missing the same on the remaining three occasions. DERM delivered a four-quarter earnings surprise of 118.25%, on average.
In the past 60 days, estimates for Entrada Therapeutics’ 2023 loss per share have narrowed from $2.07 to 9 cents. Meanwhile, loss per share estimates for 2024 have narrowed from $2.35 to $2.04. Year to date, shares of TRDA have risen 5.3%.
Earnings of Entrada Therapeutics beat estimates in three of the last four quarters while missing the same on the remaining occasion. TRDA delivered a four-quarter average earnings surprise of 70.68%.
In the past 60 days, estimates for Puma Biotechnology’s 2023 earnings per share have improved from 67 cents to 72 cents. During the same period, earnings per share estimates for 2024 have moved up from 55 cents to 64 cents. Year to date, shares of PBYI have lost 2.4%.
Earnings of Puma Biotechnology beat estimates in three of the last four quarters while missing the same on the remaining occasion. PBYI delivered a four-quarter average earnings surprise of 76.55%.
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Merck's (MRK) Keytruda, Lenvima Endometrial Cancer Study Fails
Merck & Co., Inc. (MRK - Free Report) along with partner Eisai announced data from the phase III LEAP-001 study, which evaluated the combination of blockbuster PD-1 inhibitor, Keytruda and Eisai’s TKI inhibitor, Lenvima for the first-line treatment of advanced/recurrent endometrial carcinoma.
The study failed to achieve the dual primary endpoints of overall survival (“OS”) and progression free survival (“PFS”).
The LEAP-001 study evaluated the combination of Keytruda plus Lenvima for the first-line treatment of patients with advanced or recurrent endometrial carcinoma whose disease is mismatch repair proficient (pMMR)/not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)/MSI-H.
The final analysis of the study showed that the Keytruda/Lenvima combination failed to show a sufficient improvement in OS or PS to meet the study’s prespecified statistical criteria for treating certain patients with advanced or recurrent endometrial carcinoma in the first-line setting versus a standard of care, platinum-based chemotherapy doublet (carboplatin plus paclitaxel).
The safety profile of Keytruda plus Lenvima was similar to that observed in earlier reported studies that evaluated the same combination therapy.
Shares of Merck have lost 6.5% year to date against the industry’s 4.3% growth.
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 following prior systemic therapy and advanced renal cell carcinoma (“RCC”).
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.
Per the company, data from the LEAP-001 study will not affect the currently approved indication for Keytruda plus Lenvima combination as well as the studies that are evaluating the same drug combination.
We note that the latest setback to the LEAP-001 study follows a series of setbacks suffered by Merck and Eisai on the Keytruda/Lenvima combination in the LEAP program.
In September 2023, Merck and Eisai announced data from two late-stage clinical studies that evaluated the Keytruda plus Lenvima combination in patients with certain types of metastatic non-small cell lung cancer (“NSCLC”).
Both studies, LEAP-006 and LEAP-008, failed to achieve their dual primary endpoints of OS and PFS. The studies also did not demonstrate a statistically significant improvement in objective response rate (“ORR”), a key secondary endpoint in both studies.
In August 2023, Merck and Eisai announced the closure of the phase III LEAP-010 study on the 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 the Keytruda/Lenvima combination for the first-line treatment of adults with unresectable or metastatic melanoma. Patients treated with the combination did not demonstrate improvement in 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.
Despite the ongoing setbacks, Merck and Eisai plan to continue to study the Keytruda/Lenvima combination, targeting other difficult-to-treat cancers.
Zacks Rank & Stocks to Consider
Merck currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector are Journey Medical Corporation (DERM - Free Report) , Entrada Therapeutics, Inc. (TRDA - Free Report) and Puma Biotechnology, Inc. (PBYI - Free Report) , each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Journey Medical’s 2023 loss per share have narrowed from $1.28 to 16 cents. Meanwhile, loss per share estimates for 2024 have narrowed from 41 cents to 35 cents. Year to date, shares of DERM have surged 203.1%.
Earnings of Journey Medical beat estimates in one of the last four quarters while missing the same on the remaining three occasions. DERM delivered a four-quarter earnings surprise of 118.25%, on average.
In the past 60 days, estimates for Entrada Therapeutics’ 2023 loss per share have narrowed from $2.07 to 9 cents. Meanwhile, loss per share estimates for 2024 have narrowed from $2.35 to $2.04. Year to date, shares of TRDA have risen 5.3%.
Earnings of Entrada Therapeutics beat estimates in three of the last four quarters while missing the same on the remaining occasion. TRDA delivered a four-quarter average earnings surprise of 70.68%.
In the past 60 days, estimates for Puma Biotechnology’s 2023 earnings per share have improved from 67 cents to 72 cents. During the same period, earnings per share estimates for 2024 have moved up from 55 cents to 64 cents. Year to date, shares of PBYI have lost 2.4%.
Earnings of Puma Biotechnology beat estimates in three of the last four quarters while missing the same on the remaining occasion. PBYI delivered a four-quarter average earnings surprise of 76.55%.