Merck's Keytruda Plus Chemotherapy Achieves Positive Top-Line Results in Phase II/III KEYNOTE-483 Trial for First-Line Treatment of Unresectable Advanced or Metastatic Malignant Pleural Mesothelioma

On March 10, MSD announced that the Phase II/III KEYNOTE-483 study of pembrolizumab (Keytruda), a PD-1 monoclonal antibody, combined with chemotherapy as a first-line treatment for unresectable advanced or metastatic malignant pleural mesothelioma, had met its primary endpoint of overall survival (OS).

KEYNOTE-483 Study Aims to Evaluate the Efficacy of Keytruda in Combination with Chemotherapy for Patients with Unresectable Advanced Malignant Pleural Mesothelioma, with the Primary Endpoint Being OS, and Secondary Endpoints Including Progression-Free Survival (PFS) and Objective Response Rate (ORR).

A total of 440 patients participated in the study and were randomly assigned to receive either Keytruda 200 mg every 3 weeks (for up to 35 cycles) in combination with pemetrexed (500 mg/m² every 3 weeks for 6 cycles) and cisplatin (75 mg/m² every 3 weeks for 6 cycles; carboplatin may be substituted), or pemetrexed and cisplatin (carboplatin may be substituted) alone.

The results showed that, compared with chemotherapy alone, Keytruda combined with chemotherapy can achieve statistically significant and clinically meaningful improvement in OS for patients. In addition, the safety of Keytruda combined with chemotherapy in this study was consistent with previous studies.

Malignant mesothelioma generally occurs in the lining of areas such as the chest, abdomen, heart, and testicles. It is estimated that there were approximately 30,000 new cases of malignant mesothelioma diagnosed globally in 2020, with over 26,000 deaths. Pleural mesothelioma, which occurs in the lining of the lungs, is the most common form of mesothelioma, accounting for about 75% of cases. Malignant pleural mesothelioma often progresses rapidly, with a five-year survival rate of only 12%. Although the incidence of malignant mesothelioma is gradually declining in the United States, the global incidence continues to rise due to ongoing asbestos use/exposure worldwide.

Dr. Eliav Barr, Senior Vice President of MSD, Head of Global Clinical Development and Chief Medical Officer, said: "Malignant pleural mesothelioma is a rapidly progressing cancer with a poor prognosis, and patients need new therapies that can improve survival. The positive results of this study support the potential of Keytruda in combination with chemotherapy to become a first-line treatment for the most common type of malignant mesothelioma."

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