A new clinical trial involving durvalumab should be closely monitored by the Food and Drug Administration. The phase III clinical trial is being performed in Baltimore, Cleveland, and Ann Arbor as well as places in New Zealand and Australia. The randomized trial is known as DREAM3R. It wants to figure out if overall survival improves when durvalumab is combined with the chemotherapy combination pemetrexed and cisplatin. The end goal of this study and other studies like it is to find a first line treatment for patients struggling with mesothelioma since there are not enough treatments that can help cure or at least improve mesothelioma outlook.
The most recent drug combination to be approved was the combination of the immunotherapy drugs Opdivo and Yervoy. It was the first time in 15 years that a treatment was approved for the disease. The hardest to treat mesothelioma cell types, sarcomatoid and biphasic, had their survival more than double but epithelioid mesothelioma did not see much of a benefit. It is believed that durvalumab can help the epithelioid patients who have not seen a survival benefit with approved treatments. The DREAM3R trial should be a good option for 75 percent of mesothelioma patients who struggle with the epithelioid subtype.
The new study was created because doctors saw effectiveness in two different phase II trials in the United States, Australia, and New Zealand. The trial saw survival rates of 70.4 percent at the 12-month mark and 44.2 percent at the 24-month mark. The median overall survival was 20.4 months which is much longer than the 12.1 months for chemotherapy. Australia and New Zealand had 31 out of 54 patients reach a six-month progression-free survival. The DREAM3R study wants 480 patients with unresectable (can’t have surgery) pleural mesothelioma randomized 2:1. Patients will receive the durvalumab treatment with four to six rounds of chemotherapy or just chemotherapy alone. The experimental group will have maintenance durvalumab treatments until an unacceptable amount of toxicity is found, the disease progresses, or a patient withdraws. When the control patients have disease progression, they will be offered second-line treatment.
Durvalumab works by creating an antibody called a checkpoint inhibitor. It negates the protein that protects cancer cells from the immune system. The immune system is then able to find and kill cancer cells. It was approved for bladder cancer and is showing results in lung cancer. There are currently eight clinical trials that are studying durvalumab involving other drugs and surgery for mesothelioma.
Sources:
“Durvalumab immunotherapy proceeds to phase 3 trial for malignant pleural mesothelioma” PrECOG (March 17, 2021). [Link]
“Durvalumab With Chemotherapy as First Line Treatment in Advanced Pleural Mesothelioma (DREAM3R)” ClinicalTrials.gov (April 2, 2021). [Link]
