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Merck's (MRK) Keytruda Receives EU Nod in Gastric Cancer
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Merck (MRK - Free Report) announced that the European Commission (“EC”) granted label expansion to its blockbuster drug Keytruda, as part of a combination regimen for first-line treatment of certain adult patients with gastric or gastroesophageal junction (“GEJ”) adenocarcinoma.
The EC has approved Keytruda, combined with trastuzumab and chemotherapy, for the first-line treatment of locally advanced unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma in patients whose tumors express PD-L1.
Following the EC approval, Keytruda is now the first immunotherapy approved for the first-line treatment of this patient population.
The approval was expected as last month the European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) recommended approving Keytruda for use in the above indication.
The CHMP and EC decisions are based on results from the phase III KEYNOTE-811 study, wherein patients treated with the Keytruda combination witnessed significant improvement in progression-free survival compared to those treated with trastuzumab-chemotherapy combo. The overall survival (OS) analysis for this study is ongoing.
Merck received accelerated approval from the FDA in 2021 for the Keytruda-trastuzumab-chemotherapy combination in a similar indication.
Merck’s shares have lost 0.9% year to date against the industry’s 8.1% growth.
Image Source: Zacks Investment Research
Merck has an extensive clinical development program evaluating Keytruda in gastrointestinal cancers, including in the early stage of the disease. In April, the FDA accepted the company’s label expansion filing seeking approval for using Keytruda plus chemotherapy as first-line treatment of patients with locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. A final decision is expected in December.
Gastric cancer tends to develop slowly over many years and rarely causes early symptoms, resulting in most cases going undetected until it reaches an advanced stage. Per Merck, the five-year survival rate for patients diagnosed with gastric cancer at an advanced stage is only 6%. Management also estimates that this year, in the United States alone, there will be approximately 26,500 patients diagnosed with gastric cancer and 11,000 deaths from the disease.
Keytruda, the key revenue generator for Merck, is already approved for treating many cancers globally. In first-half 2023, Merck recorded $12.1 billion in sales from Keytruda, up 20% year over year. Drug sales are gaining from continued strong momentum in metastatic indications and rapid uptake across recent earlier-stage launches. Keytruda is continuously growing and expanding into new indications and markets globally.
Merck is also evaluating Keytruda across many indications that are progressing well. Keytruda is being studied for more than 30 types of cancer indications in more than 1700 studies, including combination studies. If approved, label expansions for new cancer indications can further boost sales.
Merck currently carries a Zacks Rank #3 (Hold). Some other top-ranked stocks in the overall healthcare sector include Annovis Bio (ANVS - Free Report) , Eton Pharmaceuticals (ETON - Free Report) and Johnson & Johnson (JNJ - Free Report) . While Eton sports a Zacks Rank #1 (Strong Buy), Annovis and J&J carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, estimates for Eton Pharmaceuticals’ 2023 loss per share have narrowed from 31 cents to 10 cents. During the same period, the earnings per share estimates for 2024 have risen from 9 cents to 26 cents. Year to date, shares of ETON have surged 59.2%.
Earnings of Eton Pharmaceuticalsbeat estimates in each of the last four quarters, witnessing an earnings surprise of 162.14% on average. In the last reported quarter, Eton’s earnings beat estimates by 300.00%.
In the past 30 days, estimates for Annovis Bio’s 2023 loss per share have narrowed from $4.89 to $4.38. During the same period, the loss estimates per share for 2024 have improved from $3.18 to $2.77. Year to date, shares of ANVS have lost 8.6%.
Earnings of Annovis Bio beat estimates in three of the last four quarters while missing the mark on one occasion, witnessing an earnings surprise of 13.40% on average. In the last reported quarter, Annovis’ earnings beat estimates by 6.14%.
In the past 30 days, estimates for J&J’s 2023 earnings per share have increased from $10.73 to $10.75. During the same period, the earnings estimates per share for 2024 have risen from $11.28 to $11.30. Shares of J&J are down 7.0% in the year-to-date period.
Earnings of J&J beat estimates in each of the last four quarters, witnessing an average surprise of 5.58%. In the last reported quarter, J&J’s earnings beat estimates by 7.28%.
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Merck's (MRK) Keytruda Receives EU Nod in Gastric Cancer
Merck (MRK - Free Report) announced that the European Commission (“EC”) granted label expansion to its blockbuster drug Keytruda, as part of a combination regimen for first-line treatment of certain adult patients with gastric or gastroesophageal junction (“GEJ”) adenocarcinoma.
The EC has approved Keytruda, combined with trastuzumab and chemotherapy, for the first-line treatment of locally advanced unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma in patients whose tumors express PD-L1.
Following the EC approval, Keytruda is now the first immunotherapy approved for the first-line treatment of this patient population.
The approval was expected as last month the European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) recommended approving Keytruda for use in the above indication.
The CHMP and EC decisions are based on results from the phase III KEYNOTE-811 study, wherein patients treated with the Keytruda combination witnessed significant improvement in progression-free survival compared to those treated with trastuzumab-chemotherapy combo. The overall survival (OS) analysis for this study is ongoing.
Merck received accelerated approval from the FDA in 2021 for the Keytruda-trastuzumab-chemotherapy combination in a similar indication.
Merck’s shares have lost 0.9% year to date against the industry’s 8.1% growth.
Image Source: Zacks Investment Research
Merck has an extensive clinical development program evaluating Keytruda in gastrointestinal cancers, including in the early stage of the disease. In April, the FDA accepted the company’s label expansion filing seeking approval for using Keytruda plus chemotherapy as first-line treatment of patients with locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. A final decision is expected in December.
Gastric cancer tends to develop slowly over many years and rarely causes early symptoms, resulting in most cases going undetected until it reaches an advanced stage. Per Merck, the five-year survival rate for patients diagnosed with gastric cancer at an advanced stage is only 6%. Management also estimates that this year, in the United States alone, there will be approximately 26,500 patients diagnosed with gastric cancer and 11,000 deaths from the disease.
Keytruda, the key revenue generator for Merck, is already approved for treating many cancers globally. In first-half 2023, Merck recorded $12.1 billion in sales from Keytruda, up 20% year over year. Drug sales are gaining from continued strong momentum in metastatic indications and rapid uptake across recent earlier-stage launches. Keytruda is continuously growing and expanding into new indications and markets globally.
Merck is also evaluating Keytruda across many indications that are progressing well. Keytruda is being studied for more than 30 types of cancer indications in more than 1700 studies, including combination studies. If approved, label expansions for new cancer indications can further boost sales.
Merck & Co., Inc. Price
Merck & Co., Inc. price | Merck & Co., Inc. Quote
Zacks Rank & Stocks to Consider
Merck currently carries a Zacks Rank #3 (Hold). Some other top-ranked stocks in the overall healthcare sector include Annovis Bio (ANVS - Free Report) , Eton Pharmaceuticals (ETON - Free Report) and Johnson & Johnson (JNJ - Free Report) . While Eton sports a Zacks Rank #1 (Strong Buy), Annovis and J&J carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, estimates for Eton Pharmaceuticals’ 2023 loss per share have narrowed from 31 cents to 10 cents. During the same period, the earnings per share estimates for 2024 have risen from 9 cents to 26 cents. Year to date, shares of ETON have surged 59.2%.
Earnings of Eton Pharmaceuticalsbeat estimates in each of the last four quarters, witnessing an earnings surprise of 162.14% on average. In the last reported quarter, Eton’s earnings beat estimates by 300.00%.
In the past 30 days, estimates for Annovis Bio’s 2023 loss per share have narrowed from $4.89 to $4.38. During the same period, the loss estimates per share for 2024 have improved from $3.18 to $2.77. Year to date, shares of ANVS have lost 8.6%.
Earnings of Annovis Bio beat estimates in three of the last four quarters while missing the mark on one occasion, witnessing an earnings surprise of 13.40% on average. In the last reported quarter, Annovis’ earnings beat estimates by 6.14%.
In the past 30 days, estimates for J&J’s 2023 earnings per share have increased from $10.73 to $10.75. During the same period, the earnings estimates per share for 2024 have risen from $11.28 to $11.30. Shares of J&J are down 7.0% in the year-to-date period.
Earnings of J&J beat estimates in each of the last four quarters, witnessing an average surprise of 5.58%. In the last reported quarter, J&J’s earnings beat estimates by 7.28%.