On September 17, 2024, FDA officials approved pembrolizumab (Keytruda, Merck) with pemetrexed and platinum chemotherapy as first-line treatment of unresectable advanced or metastatic malignant pleural mesothelioma (MPM).1
The researchers investigated efficacy in KEYNOTE-483 (NCT02784171), an open-label trial in patients with unresectable advanced or metastatic MPM and no prior systemic therapy for advanced/metastatic disease. Patients were randomized 1:1 to receive either pembrolizumab for up to 2 years in combination with pemetrexed and platinum-based chemotherapy for up to 6 cycles (n=222) or pemetrexed and platinum-based chemotherapy for up to 6 cycles (n=218).
The trial demonstrated a statistically significant improvement in overall survival (OS) for patients treated with pembrolizumab with chemotherapy compared with those who received chemotherapy alone. Median OS was 17.3 months (95% CI, 14.4-21.3) versus 16.1 months (95% CI, 13.1-18.2) (HR, 0.79; 95% CI, 0.64-0.98; P=.0162).
Median progression-free survival (PFS) was 7.1 months (95% CI, 6.9-8.1) versus 7.1 months (95% CI, 6.8-7.7) in pembrolizumab plus chemotherapy and the chemotherapy alone arm, respectively (HR, 0.80; 95% CI, .65-.99; P=.0194). Confirmed ORR was 52% (95% CI, 45.5-59.0) in the pembrolizumab plus chemotherapy arm and 29% (95% CI, 23.0-35.4) in the chemotherapy-alone arm. Median duration of response was 6.9 months (95% CI, 5.8-8.3) and 6.8 months (95% CI, 5.5-8.5), respectively.
Adverse reactions occurring in patients with MPM were similar to those receiving pembrolizumab with pemetrexed and platinum chemotherapy. See the prescribing information for complete details.
References
- FDA approves pembrolizumab with chemotherapy for unresectable advanced or metastatic malignant pleural mesothelioma. FDA. September 17, 2024. Accessed October 10, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-chemotherapy-unresectable-advanced-or-metastatic-malignant-pleural