In a significant development for patients battling a rare and aggressive cancer, the FDA has granted approval to Merck & Co Inc’s Keytruda (pembrolizumab) for use in combination with pemetrexed and platinum chemotherapy. This approval marks the first time Keytruda has been indicated for the treatment of malignant pleural mesothelioma (MPM) in the United States.
MPM is a serious cancer that originates in the lining of the lungs and chest. The FDA’s decision to approve Keytruda for this indication is based on compelling data from the pivotal Phase 2/3 IND.227/KEYNOTE-483 clinical trial. The trial demonstrated that Keytruda, when combined with chemotherapy, resulted in a statistically significant improvement in overall survival (OS). Patients receiving this combination therapy experienced a 21% lower risk of death compared to those treated with chemotherapy alone. Median OS was observed to be 17.3 months for the Keytruda plus chemotherapy group, in contrast to 16.1 months for the chemotherapy-only group.
Furthermore, the trial revealed that the combination therapy also significantly improved progression-free survival (PFS) compared to chemotherapy alone. The overall response rate (ORR) was notably higher for the Keytruda plus chemotherapy group (52%) compared to chemotherapy alone (29%).
Adverse reactions experienced by patients with MPM treated with Keytruda in combination with pemetrexed and platinum chemotherapy were generally consistent with those observed in other patients receiving this treatment regimen.
This approval represents a significant step forward in the treatment of MPM. It offers patients a new and potentially life-extending treatment option. As a result of this approval, MRK stock is trading at $118.34, up 0.04% at the time of this writing.
