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Merck's Keytruda Offers Survival Benefit in Lung Cancer Study
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Merck & Co., Inc. (MRK - Free Report) announced data from a phase III study which showed that treatment with its PD-1 inhibitor, Keytruda monotherapy led to significantly improved overall survival (OS) as a first-line therapy in certain lung cancer patients.
The pivotal KEYNOTE-042 study evaluated patients with locally advanced or metastatic nonsquamous or squamous non-small cell lung cancer (NSCLC) whose tumors express PD-L1 protein levels of 1 percent or greater (TPS of ≥1 percent). In such patients, Keytruda showed a significant survival benefit compared with platinum-based chemotherapy
Notably, Keytruda monotherapy is already marketed for the first-line treatment of patients with metastatic NSCLC whose tumors express PD-L1 protein levels of 50 percent or greater (TPS of ≥50 percent) based on data from the KEYNOTE-024 study.
If the OS data from KEYNOTE-042 study are approved to be included in Keytruda’s label, the drug can be prescribed to treat an expanded lung cancer patient population, further reinforcing its position in the lung cancer market.
The study will continue to evaluate progression-free survival (PFS) — the secondary endpoint — based on recommendation of an independent Data Monitoring Committee (“DMC”).
Later in the year, Merck will present data from the KEYNOTE-042 study medical meeting and will also file regulatory application to get the OS data from the study included in the label of Keytruda.
Shares of Merck were up more than 5% on Apr 9 after the news was announced before market open. This year so far, Merck’s shares have outperformed the industry. Its shares have risen 0.7% in the period against the industry’s decline of 3.6%.
Meanwhile, Keytruda is being evaluated in several lung cancer studies across multiple settings and stages of the disease, both as a monotherapy as well as a combination therapy.
Keytruda is the second largest product in the Merck portfolio. It is marketed for many types of cancer and treatment settings including lung cancer, melanoma, head and neck cancer, classical Hodgkin’s lymphoma, gastric cancer, bladder cancer and microsatellite instability-high (MSI-H) or mismatch repair deficient cancer.
The treatment fetched sales of $3.8 billion in 2017, up almost 172% year over year. This upside is driven by the global launch of new indications, which further bolstered demand. Keytruda sales are gaining, particularly from strong momentum in the first-line lung cancer indication. In fact, Keytruda is the only anti-PD-1 approved in the first-line setting for certain lung cancer patients both as a monotherapy as well as a combination therapy with Eli Lilly’s (LLY - Free Report) cancer drug Alimta (pemetrexed) and carboplatin (pem/carbo).
The Keytruda development program also significantly advanced in 2017 with several regulatory approvals in the United States, Europe and Japan. The new approvals expanded the patient population, driving up sales last year. The positive momentum is expected to sustain in 2018 as well.
Meanwhile, Keytruda is being studied for more than 30 types of cancer, in more than 700 studies, including in excess of 400 combination studies. Merck is collaborating with several companies including Amgen (AMGN - Free Report) , Incyte, Glaxo (GSK - Free Report) and Pfizer separately for the evaluation of Keytruda in combination with other regimens.
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Merck's Keytruda Offers Survival Benefit in Lung Cancer Study
Merck & Co., Inc. (MRK - Free Report) announced data from a phase III study which showed that treatment with its PD-1 inhibitor, Keytruda monotherapy led to significantly improved overall survival (OS) as a first-line therapy in certain lung cancer patients.
The pivotal KEYNOTE-042 study evaluated patients with locally advanced or metastatic nonsquamous or squamous non-small cell lung cancer (NSCLC) whose tumors express PD-L1 protein levels of 1 percent or greater (TPS of ≥1 percent). In such patients, Keytruda showed a significant survival benefit compared with platinum-based chemotherapy
Notably, Keytruda monotherapy is already marketed for the first-line treatment of patients with metastatic NSCLC whose tumors express PD-L1 protein levels of 50 percent or greater (TPS of ≥50 percent) based on data from the KEYNOTE-024 study.
If the OS data from KEYNOTE-042 study are approved to be included in Keytruda’s label, the drug can be prescribed to treat an expanded lung cancer patient population, further reinforcing its position in the lung cancer market.
The study will continue to evaluate progression-free survival (PFS) — the secondary endpoint — based on recommendation of an independent Data Monitoring Committee (“DMC”).
Later in the year, Merck will present data from the KEYNOTE-042 study medical meeting and will also file regulatory application to get the OS data from the study included in the label of Keytruda.
Shares of Merck were up more than 5% on Apr 9 after the news was announced before market open. This year so far, Merck’s shares have outperformed the industry. Its shares have risen 0.7% in the period against the industry’s decline of 3.6%.
Meanwhile, Keytruda is being evaluated in several lung cancer studies across multiple settings and stages of the disease, both as a monotherapy as well as a combination therapy.
Keytruda is the second largest product in the Merck portfolio. It is marketed for many types of cancer and treatment settings including lung cancer, melanoma, head and neck cancer, classical Hodgkin’s lymphoma, gastric cancer, bladder cancer and microsatellite instability-high (MSI-H) or mismatch repair deficient cancer.
The treatment fetched sales of $3.8 billion in 2017, up almost 172% year over year. This upside is driven by the global launch of new indications, which further bolstered demand. Keytruda sales are gaining, particularly from strong momentum in the first-line lung cancer indication. In fact, Keytruda is the only anti-PD-1 approved in the first-line setting for certain lung cancer patients both as a monotherapy as well as a combination therapy with Eli Lilly’s (LLY - Free Report) cancer drug Alimta (pemetrexed) and carboplatin (pem/carbo).
The Keytruda development program also significantly advanced in 2017 with several regulatory approvals in the United States, Europe and Japan. The new approvals expanded the patient population, driving up sales last year. The positive momentum is expected to sustain in 2018 as well.
Meanwhile, Keytruda is being studied for more than 30 types of cancer, in more than 700 studies, including in excess of 400 combination studies. Merck is collaborating with several companies including Amgen (AMGN - Free Report) , Incyte, Glaxo (GSK - Free Report) and Pfizer separately for the evaluation of Keytruda in combination with other regimens.
Merck carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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