FDA grants priority review to application for Keytruda (pembrolizumab) plus chemotherapy as first-line treatment of patients with unresectable advanced or metastatic malignant pleural mesothelioma
Merck Inc,, known as MSD outside of the United States and Canada, announced the FDA has accepted for priority review a new supplemental Biologics License Application (sBLA) seeking approval for Keytruda, Merck’s anti-PD-1 therapy, in combination with chemotherapy, for the first-line treatment of patients with unresectable advanced or metastatic malignant pleural mesothelioma. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of September 25, 2024.
The sBLA is based on data from the pivotal Phase II/III IND.227/KEYNOTE-483 trial. Results from the final analysis of th/e study, presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, showed Keytruda in combination with chemotherapy demonstrated a statistically significant improvement in overall survival (OS), reducing the risk of death by 21% (HR=0.79 [95% CI, 0.64-0.98]; two-sided p value=0.0324), with a median OS of 17.3 months (95% CI, 14.4-21.3) versus 16.1 months (3.1-18.2) for chemotherapy alone. Keytruda plus chemotherapy also demonstrated a significant improvement in progression-fr95% CI, 1ee 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. At 12 months, the estimated PFS rate was 26% for Keytruda plus chemotherapy versus 17% for chemotherapy alone. The ORR was significantly higher for Keytruda plus chemotherapy versus chemotherapy alone (62% versus 38%, p<0.0001). the safety profile of keytruda plus chemotherapy in this study was consistent with previously reported studies.>
“Malignant pleural mesothelioma is typically diagnosed in advanced stages when curative surgery is not an option, and progresses quickly,” said Dr. Gregory Lubiniecki, vice president, oncology clinical research, Merck Research Laboratories. “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.”
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