In this article
- FDA Approves Pembrolizumab with Chemotherapy for Unresectable Advanced or Metastatic Malignant Pleural Mesothelioma
- KEYNOTE-483 Trial – Effectiveness and Safety of Pembrolizumab in Malignant Pleural Mesothelioma
- Recommended Dosage of Pembrolizumab for Malignant Pleural Mesothelioma
- How CancerFax Helps
On September 17, 2024, the Food and Drug Administration authorized pembrolizumab (Keytruda, Merck) in conjunction with pemetrexed and platinum-based chemotherapy as the initial treatment for unresectable advanced or metastatic malignant pleural mesothelioma (MPM).
The efficacy was examined in KEYNOTE-483 (NCT02784171), a randomized, open-label trial involving patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM) who had not had prior systemic therapy for advanced or metastatic illness. Patients were randomized (1:1) to receive either pembrolizumab for a maximum of 2 years in conjunction with pemetrexed and platinum-based chemotherapy for up to 6 cycles (n=222) or pemetrexed and platinum-based chemotherapy alone for up to 6 cycles (n=218).
The primary effectiveness endpoint was overall survival (OS). The supplementary efficacy outcome variables included progression-free survival (PFS), objective response rate (ORR), and duration of response (DoR), evaluated by blinded independent central review in accordance with modified RECIST 1.1 for mesothelioma.
The trial exhibited a statistically significant enhancement in overall survival for individuals administered pembrolizumab in conjunction with chemotherapy, in contrast to those who got chemotherapy solely. The median overall survival (OS) was 17.3 months (95% confidence interval [CI]: 14.4, 21.3) compared to 16.1 months (95% CI: 13.1, 18.2), with a hazard ratio (HR) of 0.79 (95% CI: 0.64, 0.98; p=0.0162).
The median progression-free survival (PFS) was 7.1 months (95% CI: 6.9, 8.1) for the pembrolizumab plus chemotherapy group and 7.1 months (95% CI: 6.8, 7.7) for the chemotherapy alone group, respectively (HR 0.80 [95% CI: 0.65, 0.99]; p=0.0194).
The confirmed overall response rate (ORR) was 52% (95% confidence interval: 45.5, 59.0) in the pembrolizumab plus chemotherapy group and 29% (95% confidence interval: 23.0, 35.4) in the chemotherapy-only group. The median duration of response (DoR) was 6.9 months (95% confidence interval: 5.8, 8.3) and 6.8 months (95% confidence interval: 5.5, 8.5), respectively.
Adverse effects in people with MPM were comparable to those in those taking pembrolizumab in conjunction with pemetrexed and platinum-based chemotherapy. Refer to the prescription information for comprehensive details.
The advised dosage of pembrolizumab is 200 mg every three weeks or 400 mg every six weeks, continuing until disease progression or intolerable toxicity, for a maximum duration of two years.
How CancerFax Helps
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CancerFax does not guarantee treatment access, eligibility, or clinical outcome. Our role is to help patients access accurate information, structured review, and appropriate specialist pathways.
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About Dr. Nishant Mittal
Dr. Nishant Mittal is a highly accomplished researcher with over 13 years of experience in the fields of cardiovascular biology and cancer research. Significant contributions to stem cell biology, developmental biology, and innovative research techniques mark his career. Research Highlights Dr. Mittal's research has focused on several key areas: 1) Cardio…
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Medical Disclaimer
This article is for educational purposes only and should not replace medical advice, diagnosis, or treatment from a qualified oncology specialist. Every patient's case is different. Treatment decisions should always be made after a review of complete medical records by the treating medical team.
Treatment availability, eligibility, timelines, and access can change. Any clinical trial participation depends on detailed review and approval by the trial hospital or investigator.