A new first line treatment was approved by the U.S. Food and Drug Administration for the treatment of pleural mesothelioma that cannot be removed by surgery. The approval is specifically for Keytruda alongside pemetrexed and platinum chemotherapy. The approval follows the promising results in phases 2 and 3 of the Keynote-483 trial. The trial consisted of 440 patients with advanced or metastatic malignant pleural mesothelioma who had cancer that could not be removed by surgery. The patients in the study had not received prior systemic therapy. The Keytruda regimen was compared against pemetrexed with cisplatin or carboplatin in addition to chemotherapy drugs alone. Keynote-483 results were compared against the pemetrexed regimen and the chemotherapy alone regimen. Keytruda showed significant survival benefits compared to the pemetrexed regimen, cutting the risk of death by 21 percent.
Keytruda reduced the likelihood of death or disease progression 20 percent compared to chemotherapy alone. The median overall survival was 17.3 months for patients that received the Keytruda combo, but with chemotherapy alone, the median overall survival was 16.1 months. FDA officials also claim the Keytruda regimen appears to be as safe as chemotherapy alone. Adverse reactions to the treatment with metastatic malignant pleural mesothelioma were similar to those receiving Keytruda with the combination treatment pemetrexed and platinum chemotherapy. The review was part of Project Orbis, a part of the FD Oncology Center of Excellence. Project Orbis provides a framework for the submittal and review of oncology drugs among international partners. For the review of the treatment regimen, the FDA collaborated with the Australian Therapeutic Goods Administration and Health Canada.
Options for mesothelioma treatment are usually limited because the disease is usually diagnosed at an advanced stage. Mesothelioma has a poor prognosis with the five-year survival rate being only 12 percent. The new FDA-approved combo treatment of Keytruda with chemotherapy set a new standard for mesothelioma treatment. This new treatment joins Opdivo combined with Yervoy as a first line treatment for mesothelioma. Additional clinical trials are ongoing to continue improving treatment options for mesothelioma.
Keytruda works by attaching to a specific type of immune cell. This prevents cancer cells from suppressing the immune system. Side effects of Keytruda alongside chemotherapy drugs include blisters, constipation, cough, decreased appetite, diarrhea, feeling tired or weak, fever, hair loss, joint pain, muscle pain, nausea, rash, swelling, trouble breathing, trouble sleeping, urinary tract infection, and vomiting. The FDA has approved Keytruda for the treatment of melanoma, non—small cell lung cancer, and head and neck cancers. It can be used alone or with other drugs.
