Blockbuster cancer drug combined with chemotherapy improved survival rates in a Phase 3 trial
Merck & Co. Inc. said Wednesday the U.S. Food and Drug Administration has approved its blockbuster cancer drug Keytruda as a treatment for malignant plural mesothelioma, a rare cancer associated with asbestos.
The company (MRK) said the approval is the first for Keytruda to treat MPM in the U.S. and is in combination with pemetrexed and platinum chemotherapy.
MPM is a rare and aggressive malignancy strongly associated with asbestos exposure that has a five-year survival rate of 12%, according to the National Institutes of Health.
The approval was based on data from a Phase 3 trial in which Keytruda plus chemotherapy showed a statistically significant improvement in overall survival versus chemotherapy alone. The combo treatment reduced the risk of death by 21% at the trial's final analysis.
Adverse reactions were generally similar to those in other patients receiving Keytruda and chemotherapy, said Merck.
"We're pleased to offer a new first-line treatment option for adult patients with unresectable advanced or metastatic malignant pleural mesothelioma, a disease where prognoses are generally poor," Dr. Gregory Lubiniecki, vice president of oncology clinical research at Merck Research Laboratories, said in prepared remarks.
MPM was diagnosed in more than 30,000 people in 2022 and caused more than 25,000 deaths. The cancer starts in the lining of certain parts of the body, such as the chest, abdomen, heart and testicles.
Keytruda is approved for a range of indications globally and drummed up more than $25 billion in sales in 2023. In the company's most recent quarter, Keytruda sales rose 16% to $7.3 billion.
Merck's stock was flat premarket but has gained 8.6% in the year to date, underperforming the S&P 500 SPX, which has gained 18%.
-Ciara Linnane
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