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Merck (MRK) Keytruda Studies in Difficult-to-Treat Cancers Fail
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Merck (MRK - Free Report) and partner Eisai announced updates on two phase III studies, LEAP-003 and LEAP-017, evaluating a combination of Merck’s Keytruda and Eisai’s orally available multiple receptor tyrosine kinase inhibitor, Lenvima to treat certain patients with advanced melanoma and metastatic colorectal cancer, respectively.
In the past year, shares of Merck have increased 29.7% compared with the industry’s 3.7% rise.
Image Source: Zacks Investment Research
Merck and Eisai are discontinuing the phase III LEAP-003 study which was evaluating the combination of Keytruda and Lenvima for the first-line treatment of adults with unresectable or metastatic melanoma. The decision was reached after the recommendation of an independent Data Monitoring Committee (DMC), which reviewed data from a planned interim analysis of the LEAP-003 study.
Per the DMC’s recommendation, Keytruda plus Lenvima did not demonstrate an improvement in overall survival (OS), one of the study’s dual primary endpoints, versus Keytruda alone. However, a statistically significant improvement in progression-free survival (PFS), the study’s other dual primary endpoint, was observed when treated with Keytruda plus Lenvima in an earlier interim analysis.
Merck and Eisai further reported that the phase III LEAP-017 study, evaluating Keytruda plus Lenvima for the treatment of patients with unresectable and metastatic colorectal cancer, did not meet its primary endpoint of OS. Despite witnessing an improvement trend in the final pre-specified analysis of OS, the results failed to meet the criteria for statistical significance, per the pre-specified statistical analysis plan.
For the key secondary endpoints of PFS, objective response rate and duration of response, a trend toward improvement was observed in the Kytruda plus Lenvima arm A versus regorafenib or TAS-102. However, per the pre-specified statistical analysis plan, these results were not tested for statistical significance.
In both the studies, LEAP-003 and LEAP-017, the safety profile of the combinations of drugs was consistent with previously reported data. The companies are currently conducting a thorough evaluation of the data from these studies, including pre-planned key subgroup analyses, to share the results with the scientific community.
We would like to remind the investors that Keytruda plus Lenvima is approved in the United States, European Union and Japan, for the treatment of advanced renal cell carcinoma and certain types of advanced endometrial carcinoma. Management has reaffirmed the fact that the dismal results from the LEAP-003 and LEAP-017 studies do not affect the currently approved indications for the Keytruda plus Lenvima combination. Merck and Eisai plan to continue to study the combination of drugs for other indications under the LEAP program.
In the past 60 days, the Zacks Consensus Estimate for Novo Nordisk’s 2023 earnings per share has increased from $4.20 to $4.51. In the past year, shares of Novo Nordisk shot up 31.8%.
NVO beat estimates in three out of the four trailing quarters, missing the mark on one occasion, delivering an average earnings surprise of 3%.
In the past 60 days, the Zacks Consensus Estimate for Innoviva’s 2023 earnings per share has increased from $1.04 to $1.37. In the past year, shares of Innoviva dropped 38.4%.
INVA beat estimates in one out of the four trailing quarters, missing the mark on three occasions, delivering an average negative earnings surprise of 50.78%.
In the past 60 days, the Zacks Consensus Estimate for Aptinyx’s 2023 loss per share has narrowed from 77 cents to 45 cents. In the past year, shares of Aptinyx have fallen by 90.3%.
APTX beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 6.56%.
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Merck (MRK) Keytruda Studies in Difficult-to-Treat Cancers Fail
Merck (MRK - Free Report) and partner Eisai announced updates on two phase III studies, LEAP-003 and LEAP-017, evaluating a combination of Merck’s Keytruda and Eisai’s orally available multiple receptor tyrosine kinase inhibitor, Lenvima to treat certain patients with advanced melanoma and metastatic colorectal cancer, respectively.
In the past year, shares of Merck have increased 29.7% compared with the industry’s 3.7% rise.
Image Source: Zacks Investment Research
Merck and Eisai are discontinuing the phase III LEAP-003 study which was evaluating the combination of Keytruda and Lenvima for the first-line treatment of adults with unresectable or metastatic melanoma. The decision was reached after the recommendation of an independent Data Monitoring Committee (DMC), which reviewed data from a planned interim analysis of the LEAP-003 study.
Per the DMC’s recommendation, Keytruda plus Lenvima did not demonstrate an improvement in overall survival (OS), one of the study’s dual primary endpoints, versus Keytruda alone. However, a statistically significant improvement in progression-free survival (PFS), the study’s other dual primary endpoint, was observed when treated with Keytruda plus Lenvima in an earlier interim analysis.
Merck and Eisai further reported that the phase III LEAP-017 study, evaluating Keytruda plus Lenvima for the treatment of patients with unresectable and metastatic colorectal cancer, did not meet its primary endpoint of OS. Despite witnessing an improvement trend in the final pre-specified analysis of OS, the results failed to meet the criteria for statistical significance, per the pre-specified statistical analysis plan.
For the key secondary endpoints of PFS, objective response rate and duration of response, a trend toward improvement was observed in the Kytruda plus Lenvima arm A versus regorafenib or TAS-102. However, per the pre-specified statistical analysis plan, these results were not tested for statistical significance.
In both the studies, LEAP-003 and LEAP-017, the safety profile of the combinations of drugs was consistent with previously reported data. The companies are currently conducting a thorough evaluation of the data from these studies, including pre-planned key subgroup analyses, to share the results with the scientific community.
We would like to remind the investors that Keytruda plus Lenvima is approved in the United States, European Union and Japan, for the treatment of advanced renal cell carcinoma and certain types of advanced endometrial carcinoma. Management has reaffirmed the fact that the dismal results from the LEAP-003 and LEAP-017 studies do not affect the currently approved indications for the Keytruda plus Lenvima combination. Merck and Eisai plan to continue to study the combination of drugs for other indications under the LEAP program.
Merck & Co., Inc. Price and Consensus
Merck & Co., Inc. price-consensus-chart | Merck & Co., Inc. Quote
Zacks Rank and Stocks to Consider
Merck currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the drugs/biotech are Novo Nordisk (NVO - Free Report) , Innoviva (INVA - Free Report) and Aptinyx . Novo Nordisk currently sports a Zacks Rank #1 (Strong Buy), while Innoviva and Aptinyx carry a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, the Zacks Consensus Estimate for Novo Nordisk’s 2023 earnings per share has increased from $4.20 to $4.51. In the past year, shares of Novo Nordisk shot up 31.8%.
NVO beat estimates in three out of the four trailing quarters, missing the mark on one occasion, delivering an average earnings surprise of 3%.
In the past 60 days, the Zacks Consensus Estimate for Innoviva’s 2023 earnings per share has increased from $1.04 to $1.37. In the past year, shares of Innoviva dropped 38.4%.
INVA beat estimates in one out of the four trailing quarters, missing the mark on three occasions, delivering an average negative earnings surprise of 50.78%.
In the past 60 days, the Zacks Consensus Estimate for Aptinyx’s 2023 loss per share has narrowed from 77 cents to 45 cents. In the past year, shares of Aptinyx have fallen by 90.3%.
APTX beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 6.56%.