FDA Approves Pembrolizumab/Chemotherapy Combination in Cancer Treatment for Advanced Mesothelioma
New Treatment Aims to Improve Cancer Outcomes
The FDA has granted approval for a groundbreaking frontline treatment involving pembrolizumab (Keytruda) combined with chemotherapy for patients suffering from unresectable advanced or metastatic malignant pleural mesothelioma. This decision is based on the compelling findings from the randomized, open-label, phase 2/3 KEYNOTE-483 trial (NCT02784171).
Positive Results from KEYNOTE-483 Trial
At the 2023 American Society of Clinical Oncology Annual Meeting, data demonstrated that the combination of pembrolizumab and chemotherapy resulted in a statistically significant improvement in overall survival (OS), reducing the risk of death by 21% (HR, 0.79; 95% CI, 0.64-0.98; 2-sided P = .0324). The median OS was 17.3 months with the combination compared to 16.1 months for chemotherapy alone.
- Progression-free survival (PFS): Notably improved with pembrolizumab plus chemotherapy, showing a PFS of 7.13 months (HR, 0.80; 95% CI, 0.65-0.99; 2-sided P = .0372) compared to 7.16 months for chemotherapy alone.
- Overall response rate (ORR): The combination yielded an ORR of 62% compared to 38% for chemotherapy.
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