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Merck's (MRK) Keytruda Gets Europe Nod for Two Carcinomas

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Merck (MRK - Free Report) announced that the European Commission approved its blockbuster anti-PD-1 drug, Keytruda, in combination with Eisai’s cancer drug Lenvima, for treating first-line kidney cancer and recurrent endometrial carcinoma.

The Keytruda combination is now approved for treating adults with advance renal cell carcinoma (RCC) or kidney cancer in the first-line setting. The combination regimen received approval for treating advanced endometrial carcinoma, which starts in the uterus, in adult patients whose disease has progressed on or after treatment with a platinum-containing therapy in any setting and who are not eligible for curative surgery or radiation. Keytruda plus Lenvima were approved for both the indications in the United States in mid-2021.

The approval for first-line RCC was based on data from the phase III study — CLEAR/KEYNOTE-581 — that demonstrated that treatment with Keytruda plus Lenvima achieved statistically significant improvement in progression-free survival (“PFS”) compared to Pfizer’s (PFE - Free Report) kidney cancer drug, Sutent (sunitinib). The combination regimen reduced the risk of disease progression or death by 61% compared to Pfizer’s Sutent.

Data from the CLEAR/KEYNOTE-581 study demonstrated that treatment with the Keytruda plus Lenvima extended the median PFS to 23.9 months from 9.2 months following treatment with Pfizer’s Sutent. Merck’s Keytruda in combination with Lenvima reduced the risk of death by 34% compared to PFE’s Sutent.

Please note that Keytruda, in combination with Pfizer’s Inlya (axitinib), is already indicated for the first-line treatment of adult patients with advanced RCC in Europe.

Meanwhile, the approval for the endometrial carcinoma indication was backed by data from another phase III study — KEYNOTE-775/Study 309. Data from the late-study demonstrated that Keytruda plus Lenvima improved overall survival and PFS by 38% and 44%, respectively. The improvements were statistically significant compared to chemotherapy.

Merck’s stock has declined 8.5% this year so far against an increase of 14.2% for the industry.

Zacks Investment ResearchImage Source: Zacks Investment Research

Label expansions of Keytruda in Europe to include first-line RCC and recurrent endometrial carcinoma represents a significant opportunity.

RCC is the most common type of kidney cancer that occurs in approximately 90% of patients diagnosed with kidney cancer. Last year, in Europe, more than 138,000 people were diagnosed with kidney cancer for the first time. The cancer was responsible for more than 54,000 deaths in the same year. It is estimated that there were more than 431,000 new cases of kidney cancer worldwide in 2020.

New cases of uterine body cancer were diagnosed in more than 130,000 patients in Europe last year. Endometrial carcinoma is the most common type of cancer in the uterus. There were more than 413,000 new cases of uterine body cancer worldwide in 2020.

Keytruda, approved for various oncology indications, is the key growth driver for Merck and further label expansion of the drug will aid the top line.

Zacks Rank & Stocks to Consider

Merck currently carries a Zacks Rank #3 (Hold).

A couple of better-ranked stocks from the pharma/biotech sector include GlaxoSmithKline (GSK - Free Report) and Sarepta Therapeutics (SRPT - Free Report) , both carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Earnings per share estimates for Glaxo have moved north from $2.86 to $3.00 for 2021 and from $3.10 to $3.26 for 2022 in the past 30 days. Glaxo delivered an earnings surprise of 15.28%, on average, in the last four quarters. Shares of Glaxo have gained 12.4% so far this year.

Sarepta’s loss per share estimates have narrowed from $6.95 to $4.99 for 2021 and from $4.83 to $3.61 for 2022. Sarepta delivered an earnings surprise of 11.06%, on average, in the last four quarters.