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Merck (MRK) Gets FDA Nod for Keytruda Expansion in Gastric Cancer

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Merck (MRK - Free Report) announced that the FDA approved its blockbuster drug Keytruda for a second indication in gastric cancer.

The FDA has approved Keytruda, combined with fluoropyrimidine- and platinum-containing chemotherapy, for first-line treatment of adult patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (“GEJ”) adenocarcinoma.

The approval is based on data from the phase III KEYNOTE-859 study, wherein patients treated with the Keytruda combination demonstrated a statistically significant improvement in overall survival compared with patients who received chemotherapy only.

Last month, the European Medicines Agency's (“EMA”) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending label expansion to Keytruda for a similar indication, supported by data from the KEYNOTE-859 study. A final decision is expected before year-end.

Keytruda, combined with trastuzumab and chemotherapy, was granted accelerated approval by the FDA in 2021 for the first-line treatment of locally advanced unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma in patients whose tumors express PD-L1. In August, this combination received approval for a similar indication in the European Union.

Following this approval, a combination therapy involving Keytruda will be available to patients with HER2-negative and HER2-positive advanced gastric or GEJ adenocarcinoma. The approval marks the seventh indication for Keytruda in gastrointestinal cancers and the overall 38th indication for the drug in the country.

Merck’s shares have lost 8.1% year to date against the industry’s 2.3% growth.

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An anti-PD-1 therapy, Keytruda is Merck’s blockbuster oncology drug approved for several types of cancer, contributing around 46% of MRK’s total revenues in the first nine months of 2023. Keytruda is authorized to treat eight indications in earlier-stage cancers in the United States. Merck’s Keytruda continuously grows and expands into new indications and markets globally.

Keytruda, the key revenue generator for Merck, is already approved for treating many cancers globally. In the nine months ended September 2023, Merck recorded $18.4 billion in sales from Keytruda, up 19% year over year. Drug sales are gaining from continued strong momentum in metastatic indications and rapid uptake across recent earlier-stage launches. Keytruda is consistently growing and expanding into new indications and markets globally.

Merck is evaluating Keytruda across many indications that are progressing well. Keytruda is being studied for more than 30 types of cancer indications in more than 1600 studies, including combination studies. If approved, label expansions for new cancer indications can further boost sales.


Zacks Rank & Stocks to Consider

Merck currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the overall healthcare sector include Acadia Pharmaceuticals (ACAD - Free Report) , Allogene Therapeutics (ALLO - Free Report) and AnaptysBio (ANAB - Free Report) , all carrying a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Acadia Pharmaceuticals’ loss estimates for 2023 have narrowed from 41 cents to 34 cents per share in the past 60 days. During the same period, the estimates for 2024 earnings per share have risen from 52 cents to 90 cents. Year to date, Acadia Pharmaceuticals’ shares have gained 38.6%.

Acadia Pharmaceuticals beat earnings estimates in two of the last four quarters while missing the mark on the other two occasions, witnessing an earnings surprise of 20.69% on average. In the last reported quarter, ACAD reported an earnings surprise of 6.98%.

In the past 60 days, estimates for Allogene Therapeutics’ 2023 loss per share have narrowed from $2.25 to $2.13. During the same period, the estimates for 2024 loss per share have improved from $2.22 to $2.05. Shares of ALLO are down 55.3% in the year-to-date period.

Earnings of Allogene Therapeutics beat estimates in three of the last four quarters while meeting the mark on one occasion, witnessing an average earnings surprise of 9.87%. In the last reported quarter, Allogene’s earnings beat estimates by 30.19%.

AnaptysBio’s loss estimate has narrowed from $6.57 to $6.21 per share in the past 60 days. During the same period, the loss estimates per share for 2024 have narrowed from $6.93 to $6.24. Shares of ANAB have lost 54.0% in the year-to-date period.

The earnings of AnaptysBio beat estimates in two of the last four quarters while missing the mark on the other two occasions, posting a negative average earnings surprise of 6.48%. AnaptysBio’s earnings beat estimates by 18.02%.

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