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Merck's Keytruda Improves Survival in Head/Neck Cancer Study
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Merck & Co., Inc. (MRK - Free Report) announced that its PD-L1 inhibitor, Keytruda, met primary endpoint of overall survival (OS) in a pivotal phase III study. The phase III KEYNOTE-048 study evaluated Keytruda as a monotherapy for the first-line treatment of advanced head and neck squamous cell carcinoma (HNSCC) in patients whose tumors expressed PD-L1 (combined proportion score (CPS) ≥20).
Data from the study showed that treatment with Keytruda monotherapy led to a significantly longer OS in patients with advanced HNSCC, compared to the current standard of care for first-line HNSCC - cetuximab in combination with platinum chemotherapy (cisplatin or carboplatin).
The results were based on an interim analysis conducted by the independent Data Monitoring Committee (DMC). Meanwhile, the co-primary endpoint of progression-free-survival (PFS) was not reached at the time of the interim analysis. The DMC has recommended that the trial will continue without any further changes.
The company plans to present these results at an upcoming medical meeting and submit to regulatory authorities for approval.
We remind investors that Keytruda is already marketed for several cancer indications including lung cancer, melanoma, head and neck cancer, classical hodgkin lymphoma and bladder cancer. The drug is the first anti-PD-1 therapy to gain an FDA approval and is now already approved for use in 10 different settings involving seven different tumor types. In 2018, it has already secured an FDA nod for two new indications. These include the third-line treatment of adult as well as pediatric patients with primary mediastinal B-cell lymphoma (PMBCL), a type of non-Hodgkin lymphoma and the second-line treatment of recurrent or metastatic cervical cancer.
The drug is also being assessed for more than 30 types of cancer in above 700 trials including in excess of 400 combination studies. Merck is collaborating with several companies like Amgen (AMGN - Free Report) , Incyte, GlaxoSmithKline (GSK - Free Report) and Pfizer (PFE - Free Report) separately for the evaluation of Keytruda in combination with other regimens.
Keytruda is a key top-line driver for Merck and logged sales of $1.5 billion in first-quarter 2018, up 12.9% sequentially and 151% year over year. Sales continue to be driven by the launch of new indications globally.
Shares of Merck have rallied 12.7% year to date versus the industry’s decline of 1.4%.
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 27 billion devices in just 3 years, creating a $1.7 trillion market.
Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 6 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2020.
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Merck's Keytruda Improves Survival in Head/Neck Cancer Study
Merck & Co., Inc. (MRK - Free Report) announced that its PD-L1 inhibitor, Keytruda, met primary endpoint of overall survival (OS) in a pivotal phase III study. The phase III KEYNOTE-048 study evaluated Keytruda as a monotherapy for the first-line treatment of advanced head and neck squamous cell carcinoma (HNSCC) in patients whose tumors expressed PD-L1 (combined proportion score (CPS) ≥20).
Data from the study showed that treatment with Keytruda monotherapy led to a significantly longer OS in patients with advanced HNSCC, compared to the current standard of care for first-line HNSCC - cetuximab in combination with platinum chemotherapy (cisplatin or carboplatin).
The results were based on an interim analysis conducted by the independent Data Monitoring Committee (DMC). Meanwhile, the co-primary endpoint of progression-free-survival (PFS) was not reached at the time of the interim analysis. The DMC has recommended that the trial will continue without any further changes.
The company plans to present these results at an upcoming medical meeting and submit to regulatory authorities for approval.
We remind investors that Keytruda is already marketed for several cancer indications including lung cancer, melanoma, head and neck cancer, classical hodgkin lymphoma and bladder cancer. The drug is the first anti-PD-1 therapy to gain an FDA approval and is now already approved for use in 10 different settings involving seven different tumor types. In 2018, it has already secured an FDA nod for two new indications. These include the third-line treatment of adult as well as pediatric patients with primary mediastinal B-cell lymphoma (PMBCL), a type of non-Hodgkin lymphoma and the second-line treatment of recurrent or metastatic cervical cancer.
The drug is also being assessed for more than 30 types of cancer in above 700 trials including in excess of 400 combination studies. Merck is collaborating with several companies like Amgen (AMGN - Free Report) , Incyte, GlaxoSmithKline (GSK - Free Report) and Pfizer (PFE - Free Report) separately for the evaluation of Keytruda in combination with other regimens.
Keytruda is a key top-line driver for Merck and logged sales of $1.5 billion in first-quarter 2018, up 12.9% sequentially and 151% year over year. Sales continue to be driven by the launch of new indications globally.
Shares of Merck have rallied 12.7% year to date versus the industry’s decline of 1.4%.
Merck carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
More Stock News: This Is Bigger than the iPhone!
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 27 billion devices in just 3 years, creating a $1.7 trillion market.
Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 6 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2020.
Click here for the 6 trades >>