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Merck (MRK) Keytruda Cervical Cancer sBLA Gets FDA Priority Tag

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Merck (MRK - Free Report) announced that the FDA has accepted its supplemental biologics license application (sBLA), seeking expanded use of its blockbuster PD-L1 inhibitor, Keytruda, in cervical cancer. With the FDA granting priority review to the sBLA, a final decision is expected on Jan 20, 2024.

The sBLA is seeking approval for Keytruda (pembrolizumab) plus concurrent chemoradiotherapy for patients with newly diagnosed high-risk locally advanced cervical cancer. The sBLA is based on data from the phase III KEYNOTE-A18 study. Data from this study showed that treatment with Keytruda plus concurrent chemoradiotherapy led to a statistically significant and clinically meaningful improvement in progression-free survival in the abovementioned patient group compared to concurrent chemoradiotherapy alone.

Keytruda is presently approved for two indications of cervical cancer. The first one is in combination with chemotherapy, with or without bevacizumab, for the treatment of persistent, recurrent, or metastatic cervical cancer. The second indication is a monotherapy for recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. If the latest sBLA is approved, it would be Merck’s third approved indication in cervical cancer and the first for an earlier stage.

Merck’s stock has declined 3.3% so far this year against an increase of 7.7% for the industry.


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Keytruda is presently approved to treat seven indications in earlier-stage cancers in the United States. Sales of Keytruda rose 23%, excluding Fx impact, in the first half of 2023 to $12.06 billion. Numerous recent approvals and the expected launch of many additional indications, including in earlier lines of therapy, can further boost sales. In the United States, Merck expects over half of Keytruda’s growth to come from indications in early-stage treatment settings through 2025 and to represent roughly 25% of total global Keytruda sales by that time.

Keytruda 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 Keytruda’s long-term growth. These include innovative immuno-oncology combinations, including Keytruda with TIGIT, LAG3 and CTLA-4 inhibitors. Merck is also leveraging Keytruda benefits across several cancer types to identify and develop promising new oncology candidates.

Along with Moderna (MRNA), Merck is developing a personalized mRNA therapeutic cancer vaccine (V940/mRNA-4157) in combination with Keytruda for the treatment of adjuvant melanoma. Merck/Moderna initiated a pivotal phase III study in adjuvant melanoma in July 2023.

Zacks Rank and Stocks to Consider

Merck has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank stocks (Strong Buy) here.

Some top-ranked drug/biotech companies worth considering are Novartis (NVS - Free Report) , Aurinia Pharmaceuticals (AUPH - Free Report) and Corcept Therapeutics (CORT - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Novartis’ stock has gained 14.2% so far this year. In the past 60 days, estimates for Novartis’ 2023 earnings per share have risen from $6.81 to $6.92, while those for 2024 have improved from $7.32 to $7.52 per share.

NVS’ earnings beat estimates in the last four quarters, delivering an earnings surprise of 6.56% on average.

In the past 60 days, the loss per share estimate for Aurinia Pharmaceuticals for 2023 has narrowed from 71 cents per share to 58 cents per share, while that for 2024 has narrowed from 43 cents to 28 cents. Year to date, shares of Aurinia Pharmaceuticals have gained 93.3%.

Earnings of Aurinia Pharmaceuticals beat estimates in all the last four quarters, delivering an earnings surprise of 45.61% on average.

In the past 60 days, the Zacks Consensus Estimate for Corcept’s earnings has increased from 62 cents per share to 78 cents for 2023. The bottom-line estimate has also improved from 61 cents to 83 cents for 2024 during the same time frame. Shares of the company have rallied 57.7% year to date.

CORT’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 6.99%.

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