Merck & Co., Inc. MRK announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency's (EMA) has rendered a positive opinion recommending marketing authorization of its blockbuster anti-PD-1 therapy, Keytruda (pembrolizumab), for two types of gynecologic cancers.
The first indication involves Keytruda in combination with carboplatin and paclitaxel, followed by Keytruda as a single agent, for the first-line treatment of adult patients with primary advanced or recurrent endometrial carcinoma who are candidates for systemic therapy.
The second indication involves Keytruda in combination with chemoradiotherapy (CRT) for the treatment of FIGO (International Federation of Gynecology and Obstetrics) 2014 stage III-IVA locally advanced cervical cancer in adult patients who have not received prior definitive therapy.
The European Commission (EC) will now review the CHMP’s opinion and a decision is expected in the fourth quarter of 2024 for both indications.
Shares of Merck have risen 7.5% year to date compared with the industry's rally of 23.5%.
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Opinion Based on Data from MRK’s KEYNOTE-868 & KEYNOTE-A18 Studies
The positive CHMP opinion for the endometrial carcinoma indication was based on data from the KEYNOTE-868 study, which showed that Keytruda in combination with carboplatin and paclitaxel, followed by Keytruda alone led to a statistically significant and clinically meaningful improvement in progression-free survival (PFS) as compared to placebo plus carboplatin and paclitaxel.
The positive CHMP opinion for the cervical cancer indication was based on data from the KEYNOTE-A18 study, which showed that Keytruda, in combination with concurrent CRT, led to statistically significant and clinically meaningful improvements in overall survival (OS) and PFS versus CRT alone.
Keytruda, in combination with carboplatin and paclitaxel, followed by Keytruda as a single agent, was approved for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma in the United States in June 2024.
Meanwhile, Keytruda, in combination with CRT for the treatment of patients with FIGO 2014 Stage III-IVA cervical cancer, was approved by the FDA in January this year.
Keytruda - MRK's Biggest Revenue Driver
Keytruda is already approved for the treatment of many cancers globally and accounts for around 50% of Merck’s pharmaceutical sales.
Keytruda is approved for 40 distinct cancer indications. Sales of the drug are gaining from rapid uptake across earlier-stage indications as well as continued strong momentum in metastatic indications. The drug has played an instrumental role in driving Merck’s steady revenue growth in the past few years. Keytruda sales continue to grow year over year as well as sequentially. The drug generated sales of more than $14 billion in the first half of 2024. The company expects continued growth from Keytruda in the second half of 2024 as well.
Zacks Rank & Stocks to Consider
Merck currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the biotech sector are ANI Pharmaceuticals, Inc. ANIP, Krystal Biotech, Inc. KRYS and Fulcrum Therapeutics, Inc. FULC, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have moved up from $4.49 to $4.82. Earnings per share estimates for 2025 have improved from $5.51 to $5.93. Year to date, shares of ANIP have increased 8.2%.
ANIP’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 31.32%.
In the past 60 days, estimates for Krystal Biotech’s 2024 earnings per share have increased from $2.09 to $2.38. Earnings per share estimates for 2025 have improved from $4.33 to $7.31. Year to date, shares of KRYS have risen 48.5%.
KRYS’ earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, with the average surprise being 45.95%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from $1.33 to 28 cents. Loss per share estimates for 2025 have narrowed from $1.71 to $1.14. Year to date, shares of FULC have plunged 50.2%.
FULC’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 393.18%.
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Merck & Co., Inc. (MRK) : Free Stock Analysis Report
ANI Pharmaceuticals, Inc. (ANIP) : Free Stock Analysis Report
Krystal Biotech, Inc. (KRYS) : Free Stock Analysis Report
Fulcrum Therapeutics, Inc. (FULC) : Free Stock Analysis Report
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