Wednesday, the FDA approved Merck & Co Inc's (NYSE:MRK) Keytruda (pembrolizumab) in combination with pemetrexed and platinum chemotherapy for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM).
The approval marks the first indication for Keytruda in MPM in the U.S.
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MPM is a rare, aggressive cancer that forms in the lining of the lungs and chest.
The approval is based on pivotal Phase 2/3 IND.227/KEYNOTE-483 trial data.
Keytruda plus chemotherapy demonstrated a statistically significant improvement in overall survival (OS), reducing the risk of death by 21% compared to chemotherapy alone.
Median OS was 17.3 months for Keytruda plus chemotherapy versus 16.1 months for chemotherapy alone.
Keytruda plus chemotherapy also significantly improved progression-free survival (PFS) versus chemotherapy alone.
The overall response rate (ORR) was significantly higher for Keytruda plus chemotherapy versus chemotherapy alone (52% versus 29%), respectively.
Adverse reactions occurring in patients with MPM were generally similar to those in other patients receiving Keytruda in combination with pemetrexed and platinum chemotherapy.
In August, Merck discontinued two Keytruda late-stage studies.
- Phase 3 KEYNOTE-867 trial evaluating Keytruda (pembrolizumab) in combination with stereotactic body radiotherapy for stage I or II non-small cell lung cancer, including those who are medically inoperable or have refused surgery.
- Phase 3 KEYNOTE-630 trial of Keytruda for the adjuvant treatment of patients with high-risk locally advanced cutaneous squamous cell carcinoma (cSCC) following surgery and radiation, based on the recommendation of an independent DMC.
Price Action: MRK stock is trading 0.04% higher at $118.34 at the last check on Wednesday.
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