Merck and the Canadian Cancer Trials Group (CCTG) have reported positive data from the Phase II/III CCTG IND.227/KEYNOTE-483 trial of Keytruda, along with chemotherapy, as first-line treatment for advanced malignant pleural mesothelioma patients.
The open-label, randomised Phase II/III trial has been designed for assessing the combination of Keytruda and chemotherapy to treat unresected advanced malignant pleural mesothelioma patients.
According to the final study analysis, the combination of Keytruda and chemotherapy met the trial’s primary endpoint of overall survival (OS), demonstrating a clinically meaningful and statistically significant improvement in OS compared to chemotherapy alone.
In the trial, the safety profile of Keytruda along with chemotherapy was found to be consistent with previously reported trials.
Merck Research Laboratories senior vice-president, chief medical officer and global clinical development head Dr Eliav Barr said: “Malignant pleural mesothelioma is a rapidly progressing cancer that develops in the lining of the lungs and has a poor prognosis.
“Patients are in need of new treatments that can improve survival outcomes, and these positive results support the potential of Keytruda in combination with chemotherapy as a first-line treatment for patients with the most common form of malignant mesothelioma.”
The IND.227/KEYNOTE-483 trial was sponsored and conducted by CCTG, along with Intergroupe Francophone de Cancérologie Thoracique (IFCT) and the National Cancer Institute of Naples (NCIN).
Merck provided Keytruda as well as support for the trial.
Last month, the company reported that the combination of its Keytruda (pembrolizumab) and chemotherapy (carboplatin and paclitaxel) met the Phase III NRG-GY018 trial’s primary endpoint of progression-free survival (PFS).