Merck (MRK) Keytruda Ok'd by FDA for Expanded Cervical Cancer Use

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Merck MRK announced that the FDA has granted approval to its blockbuster anti-PD-1 therapy, Keytruda, for expanded use in cervical cancer. The approval is for Keytruda plus chemoradiotherapy (CRT) for the treatment of patients with FIGO (International Federation of Gynecology and Obstetrics) 2014 Stage III-IVA cervical cancer.

The approval is based on data from the phase KEYNOTE-A18 study, which showed that Keytruda plus CRT reduced the risk of disease progression or death by 41% compared to concurrent CRT alone in the above-mentioned patient group. With the approval, Keytruda plus CRT became the first anti-PD-1-based regimen approved in the United States for treating patients with FIGO 2014 Stage III-IVA cervical cancer regardless of PD-L1 expression.

This is Keytruda’s third-approved indication in cervical cancer in the United States. Keytruda is already approved in combination with CRT with or without Avastin (bevacizumab) for treating metastatic cervical cancer whose tumors express PD-L1. It is also approved as a monotherapy for metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1.

Merck’s stock has risen 5.6% in the past year compared with an increase of 14.7% for the industry.

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Keytruda, approved for several types of cancer, alone accounts for around 45% of Merck’s total pharmaceutical sales. Keytruda sales are gaining from continued strong momentum in metastatic indications and rapid uptake across earlier-stage launches. The drug is presently approved to treat eight indications in earlier-stage cancers in the United States. Keytruda is continuously growing and expanding into new indications and markets globally. Numerous recent approvals and the expected launch of many additional indications, including in earlier lines of therapy, can further boost sales.

The Keytruda development program is progressing well. The drug is being studied for more than 30 types of cancer, including both monotherapy and combination studies. Merck is also working on different strategies to drive the long-term growth of Keytruda. These include innovative immuno-oncology combinations, including Keytruda with TIGIT, LAG3 and CTLA-4 inhibitors. In partnership with Moderna, Merck is developing a personalized mRNA therapeutic cancer vaccine (V940/mRNA-4157) in combination with Keytruda for the treatment of adjuvant melanoma.

Zacks Rank

Merck has a Zacks Rank #3 (Hold) currently. Some better-ranked stocks in the drug/biotech sector worth considering are Fusion Pharmaceuticals FUSN, Novo Nordisk NVO and Regeneron Pharmaceuticals REGN, all three sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Merck & Co., Inc. Price and Consensus

Merck & Co., Inc. Price and Consensus
Merck & Co., Inc. Price and Consensus

Merck & Co., Inc. price-consensus-chart | Merck & Co., Inc. Quote

In the past 60 days, the consensus estimate for Fusion Pharmaceuticals’ 2024 loss has narrowed from $1.46 per share to $1.38 per share. Fusion Pharmaceuticals’ stock has surged 131.1% in the past year.

FUSN beat estimates in three of the trailing four quarters and missed the mark once, delivering an average negative earnings surprise of 2.90%.

Estimates for Novo Nordisk’s 2024 earnings per share have increased from $3.07 to $3.12 over the past 60 days. NVO’s stock has surged 57.3% in the past year.

Earnings of Novo Nordisk beat estimates in two of the last four quarters, missed in one and matched estimates in one, delivering an earnings surprise of 0.58% on average.

In the past 60 days, estimates for Regeneron’s 2024 earnings have risen from $41.57 per share to $43.96 per share. Regeneron’s stock has surged 29.2% in the past year.

Regeneron beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 12.34%.

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