The U.S Food and Drug Administration has accepted a priority review for a new Supplemental Biologics License Application. This could be a new era in the management of pleural mesothelioma, leading to a better future for those diagnosed with the cancer. The review is looking for approval of Keytruda used alongside chemotherapy. This combination could benefit those patients who cannot receive surgery or whose cancer has spread. This advancement in treatment is important because mesothelioma is typically diagnosed at a later stage when surgery is not available.
The news comes at a landmark time for people suffering from mesothelioma. The decision by the FDA is based on promising phase 2 and 3 IND.227/KEYNOTE-483 trial results. The KEYNOTE trial shows that Keytruda and chemotherapy can improve survival compared to chemotherapy alone. This offers new hope for patients since the overall survival is improved in patients. Keytruda alongside chemotherapy reduced the risk of death 21 percent compared to chemotherapy alone. Patients who received the combination treatment had a better overall response rate of 62 percent compared to 38 percent in the group only receiving chemotherapy.
The phase 3 trial consisted of 440 patients being randomized into two groups. The first group received 200 mg Keytruda intravenously every three weeks for up to 35 cycles. They also received pemetrexed and cisplatin or carboplatin every three weeks for six cycles. The second group only received chemotherapy. The median overall survival was 17.3 months for the Keytruda and chemotherapy group compared to 16.1 months for the chemotherapy only group. The Keytruda and chemotherapy group also had better progression free survival, with a 20 percent benefit in reducing the risk of disease progression or dying.
Keytruda allows the body to detect and respond to tumor cells. It works by blocking the interaction between PD-1 and its bonding targets PD-L1 and PD-L2. This allows T lymphocytes, a type of immune cell, to target cancerous cells. Keytruda is now approved for multiple cancers including melanoma, non-small-cell-lung cancer and head and neck cancers.
The FDA’s acceptance of the combination of chemotherapy and Keytruda can bring hope to patients suffering from malignant pleural mesothelioma. There were an estimated 30,000 new cases of mesothelioma diagnosed in 2022 and more than 25,000 people dying from the disease. Mesothelioma is typically diagnosed at an advanced stage when treatment options are limited. The prognosis is usually poor with only 12 percent of patients surviving for five years.
Mesothelioma rates have declined in the United States, but continued use of asbestos in other parts of the world has led to global rates of asbestos related illnesses to increase. The KEYNOTE-483 trial shows that Keytruda and chemotherapy can become a new standard treatment. This could allow better survival outcomes. If approved, the combination treatment could help slow down disease progression and improve the quality of life of patients. Improved survival from Keytruda and chemotherapy shows that there is an advancement in the fight against mesothelioma. While we wait for a final decision on the treatment becoming a standard therapy, new research will continue to help with the fight against mesothelioma and will hopefully find new treatment options for hard to treat cancers like mesothelioma.
