Merck’s KEYTRUDA® Combo Gets Fast Track for Untreated Mesothelioma

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Merck, also known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has accepted a new supplemental Biologics License Application (sBLA) for priority review. This application seeks approval for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy, for the initial treatment of patients with unresectable advanced or metastatic malignant pleural mesothelioma. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of September 25, 2024.

The sBLA submission is supported by data from the pivotal Phase 2/3 IND.227/KEYNOTE-483 trial. Results from the final analysis of the study, presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, demonstrated that KEYTRUDA in combination with chemotherapy exhibited a statistically significant improvement in overall survival (OS). This improvement was characterized by a reduction in the risk of death by 21% (HR=0.79 [95% CI, 0.64-0.98]; two-sided p value=0.0324). The median OS was 17.3 months (95% CI, 14.4-21.3) for KEYTRUDA plus chemotherapy, compared to 16.1 months (95% CI, 13.1-18.2) for chemotherapy alone. Additionally, KEYTRUDA plus chemotherapy showed significant improvements in progression-free survival (PFS) (HR=0.80 [95%CI, 0.65-0.99], two-sided p value = 0.0372; median PFS 7.13 months versus 7.16 months respectively) and objective response rate (ORR) compared to chemotherapy alone. The estimated PFS rate at 12 months was 26% for KEYTRUDA plus chemotherapy versus 17% for chemotherapy alone. The ORR was significantly higher for KEYTRUDA plus chemotherapy compared to chemotherapy alone (62% versus 38%, p<0.0001). The safety profile observed for KEYTRUDA plus chemotherapy in this study remained consistent with previously reported studies.

Dr. Gregory Lubiniecki, vice president of oncology clinical research at Merck Research Laboratories, commented on the significance of this development, stating, “Malignant pleural mesothelioma is typically diagnosed in advanced stages when curative surgery is not an option, and progresses quickly. We continue to evaluate KEYTRUDA in new and difficult-to-treat tumors and look forward to working with the FDA to help bring KEYTRUDA as a potential treatment option to certain patients with advanced malignant pleural mesothelioma.”