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Merck (MRK) Keytruda Meets Hepatocellular Carcinoma Study Goal
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Merck (MRK - Free Report) announced positive data from the phase III KEYNOTE-394 study evaluating its blockbuster drug, Keytruda, for treatment of patients with advanced hepatocellular carcinoma (“HCC”) who have received prior treatment with Bayer’s (BAYRY - Free Report) Nexavar (sorafenib).
The KEYNOTE-394 study evaluated the combination of Keytruda and best supportive care (which includes pain management as well as management of other potential complications) in comparison with the combination of placebo and best supportive care in advanced HCC patients.
The study achieved the primary endpoint of overall survival (“OS”). Data from the study demonstrated that treatment with Keytruda plus best supportive care resulted in statistically significant improvement over placebo for the primary endpoint of OS, and secondary endpoints of progression-free survival (“PFS”) and objective response rate (“ORR”).
Merck’s shares have declined 10.3% so far this year against the industry’s 8.2% increase.
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We remind investors that Keytruda was approved for the treatment of HCC patients previously treated with sorafenib under accelerated approval in November 2018. This accelerated approval was based on positive data from the KEYNOTE-224 study. Yet, the study did not meet its dual primary endpoints of OS and PFS, which was a condition for full approval for the HCC indication. In April, the FDA’s Oncologic Drugs Advisory Committee unanimously voted in favor of maintaining the accelerated approval for the advanced HCC indication. At the meeting, the committee discussed making KEYNOTE-394 a potential confirmatory study for advanced HCC indication.
HCC is the most common form of liver cancer and one of the most frequently diagnosed cancers having a five-year survival rate of less than 15%. The company estimates more than 42,200 cases of liver cancer in the United States alone. A potential regulatory approval will give a further boost to its top line.
Keytruda has already received global approvals for the treatment of multiple types of cancers. The drug continues to grow, and expand into new indications as well as global markets. In fact, Keytruda is being studied for more than 30 types of cancer in over 1550 studies, including in excess of 1100 combination studies. Several regulatory decisions for new indications in the United States and Europe are pending, which, if approved, can further boost sales. Together with the company’s other oncology drugs, Merck anticipates approval for more than 90 potential new oncology indications by 2028.
Keytruda faces stiff competition from Bristol Myers’ (BMY - Free Report) Opdivo and Roche’s (RHHBY - Free Report) Tecentriq, which are approved for multiple cancer indications either as monotherapy or as a combination with other drugs including HCC.
Image: Shutterstock
Merck (MRK) Keytruda Meets Hepatocellular Carcinoma Study Goal
Merck (MRK - Free Report) announced positive data from the phase III KEYNOTE-394 study evaluating its blockbuster drug, Keytruda, for treatment of patients with advanced hepatocellular carcinoma (“HCC”) who have received prior treatment with Bayer’s (BAYRY - Free Report) Nexavar (sorafenib).
The KEYNOTE-394 study evaluated the combination of Keytruda and best supportive care (which includes pain management as well as management of other potential complications) in comparison with the combination of placebo and best supportive care in advanced HCC patients.
The study achieved the primary endpoint of overall survival (“OS”). Data from the study demonstrated that treatment with Keytruda plus best supportive care resulted in statistically significant improvement over placebo for the primary endpoint of OS, and secondary endpoints of progression-free survival (“PFS”) and objective response rate (“ORR”).
Merck’s shares have declined 10.3% so far this year against the industry’s 8.2% increase.
We remind investors that Keytruda was approved for the treatment of HCC patients previously treated with sorafenib under accelerated approval in November 2018. This accelerated approval was based on positive data from the KEYNOTE-224 study. Yet, the study did not meet its dual primary endpoints of OS and PFS, which was a condition for full approval for the HCC indication. In April, the FDA’s Oncologic Drugs Advisory Committee unanimously voted in favor of maintaining the accelerated approval for the advanced HCC indication. At the meeting, the committee discussed making KEYNOTE-394 a potential confirmatory study for advanced HCC indication.
HCC is the most common form of liver cancer and one of the most frequently diagnosed cancers having a five-year survival rate of less than 15%. The company estimates more than 42,200 cases of liver cancer in the United States alone. A potential regulatory approval will give a further boost to its top line.
Keytruda has already received global approvals for the treatment of multiple types of cancers. The drug continues to grow, and expand into new indications as well as global markets. In fact, Keytruda is being studied for more than 30 types of cancer in over 1550 studies, including in excess of 1100 combination studies. Several regulatory decisions for new indications in the United States and Europe are pending, which, if approved, can further boost sales. Together with the company’s other oncology drugs, Merck anticipates approval for more than 90 potential new oncology indications by 2028.
Keytruda faces stiff competition from Bristol Myers’ (BMY - Free Report) Opdivo and Roche’s (RHHBY - Free Report) Tecentriq, which are approved for multiple cancer indications either as monotherapy or as a combination with other drugs including HCC.
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Merck currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.