Following similar actions by the United States and the European Union, Health Canada has announced the approval of pembrolizumab with chemotherapy for the treatment of advanced malignant pleural mesothelioma. The decision was based on the results of Phase 3 clinical trials.
Canadian Government Agency Approves Innovative Mesothelioma Treatment
The decision to approve the innovative mesothelioma treatment was announced by Health Canada, the Government of Canada’s health agency responsible for numerous federal health-related agencies. The agency’s announcement follows the release of data from a phase 2/3 IND.227/KEYNOTE-483 trial.
The clinical trial demonstrated a statistically significant improvement in overall survival, progression-free survival, and overall response rate in mesothelioma patients who were randomly assigned to receive the immunotherapy drug plus chemotherapy vs those treated with chemotherapy alone. The approval is specific to the combination’s use for first-line treatment of adult patients with unresectable advanced or metastatic disease.
Final Analysis Delivers Encouraging Results
According to scientists involved in the clinical trial, mesothelioma patients treated in the combination therapy group had a median overall survival of 17.3 months vs 16.1 months with chemotherapy alone. Progression-free survival was roughly the same, while the overall response rate was 52% in the combination group vs 29% in the chemotherapy group. The study enrolled 440 patients eligible to receive standard chemotherapy with pemetrexed and cisplatin and with no contraindications to standard chemotherapy, who had unresectable advanced and/or metastatic disease, and met other criteria.
Speaking of the agency’s decision, Quincy Chu, MD, FRCP(C), a medical oncologist at the Cross Cancer Institute and Associate Professor at the University of Alberta, said, “This approval marks the first combination treatment of Keytruda and chemotherapy in Canada for patients with malignant pleural mesothelioma. This combination provides a new therapeutic option for this patient group, which has limited options available and may help improve health outcomes.”
Improvements in treatment options offer real hope for patients diagnosed with malignant mesothelioma. If you or someone you love has been diagnosed with this rare, asbestos-related disease, the Patient Advocates at Mesothelioma.net are here to help. Contact us today at 1-800-692-8608 to learn more.
