Following positive results from clinical trials, the FDA has moved forward and granted priority review approval to the investigation of a new mesothelioma protocol. The supplemental biologics license application is for a combination of the immunotherapy drug pembrolizumab (Keytruda) being administered in combination with chemotherapy.
Treatment Protocol Targets Mesothelioma Patients with Unresectable or Metastatic Disease
Though researchers are working to find a cure, malignant mesothelioma is always considered a fatal disease, and most breakthroughs and discoveries work towards extending survival. The combination treatment that received priority review approval followed a clinical trial that targeted patients who have the most advanced disease and the fewest options.
The phase 2/3 OMD.227/KEYNOTE-483 trial, whose results were presented at the 2023 ASCO Annual meeting, worked with patients who had not received prior systemic therapy and whose disease was so advanced that it was inoperable. Few had undergone major surgery, prior radiation, or chemotherapy alone. In all, 440 patients were randomly assigned to receive 200 mg of IV Keytruda every 3 weeks for up to 35 cycles plus doses of pemetrexed every 3 weeks for 6 cycles and cisplatin every 3 weeks for 6 cycles; or pemetrexed and cisplatin alone.
Mesothelioma Clinical Trial Results Drive FDA Action
The results of the mesothelioma trial demonstrated that the 12- and 24-month progression-free survival rate delivered by the combination was 26% and 9% versus 17% and 4% with chemotherapy alone. Overall survival rates from the protocol were 39% and 25% compared to 33% and 17% with chemotherapy alone, and patients who received the combination treatment had a much higher objective response rate of 62% compared to 38%.
Speaking of the results of the test, Dr. Gregory Lubiniecki, the vice president of oncology clinical research at Merck Research Laboratories said, “Malignant pleural mesothelioma is typically diagnosed in advanced stages when curative surgery is not an option and progresses quickly. We continue to evaluate [pembrolizumab] in new and difficult-to-treat tumors and look forward to working with the FDA to help bring [pembrolizumab] as a potential treatment option to certain patients with advanced malignant pleural mesothelioma.”
If you or someone you love has been diagnosed with mesothelioma and need information, contact the Patient Advocates at Mesothelioma.net today. We can be reached at 1-800-692-8608.
