Phase Three Clinical Trial Opens for Mesothelioma Patient Enrollment
The greatest hope for extended survival in malignant mesothelioma lies in the development of new treatment protocols, but there’s a long road from innovation to approval. New drugs need to go through a rigorous clinical testing process that ensures both effectiveness and safety. One of the more promising treatments under review is the immunotherapy drug durvalumab, and researchers have just announced that they are enrolling patients with newly diagnosed unresectable malignant pleural mesothelioma for the third phase of their clinical trial, known as DREAM3R.
DREAM3R Clinical Trial for Mesothelioma Follows “Remarkable” Results
The DREAM3R clinical trial will evaluate pleural mesothelioma patient response to durvalumab immunotherapy during and after standard chemotherapy. It is a collaborative effort being conducted in the United States, New Zealand, and Australia. It follows two previous trials, PrE050 and DREAM, both of which were single-arm phase two trials that yielded excellent results.
According to Patrick Forde, MD, Lead US Investigator, Johns Hopkins University, “DREAM3R will determine if concurrent chemo-immunotherapy can improve outcomes in malignant pleural mesothelioma, especially for the majority of patients with the epithelioid subtype. Both the DREAM and PrE0505 phase 2 trials showed remarkable results in MPM with the combination of chemotherapy and durvalumab, and warrant confirmation in a randomized phase 3 trial.”
Mesothelioma Trials Are Multi-National Effort
The phase three mesothelioma trial is being pursued in the United States, New Zealand and Australia, three countries that have each suffered significant losses as a result of decades of asbestos use. While the United States’ arm of the study is being sponsored by the cancer research group PrECOG, LLC, the Australian arm is being led by the University of Sydney through its NHMRC Clinical Trials Group and the New Zealand trial by the Thoracic Oncology Group of Australasia (TOGA). All research is being supported by durvalumab’s manufacturers, Medimmune Ltd and AstraZeneca Pty Ltd.
The previous trials both showed positive results with no unexpected toxicities, with the PrE0505 trial in the United States showing median overall survival of 20.4 months compared to the control group’s 12.1 months, and the Australian DREAM trials showing six months of progression-free survival in 57% of patients. The study’s official title is DREAM3R: Durvalumab (MEDI4736) With Chemotherapy as First Line Treatment in Advanced Pleural Mesothelioma – A Phase 3 Randomized Trial.
If you or someone you love has been diagnosed with malignant mesothelioma and you need information on participating in clinical trials, the Patient Advocates at Mesothelioma.net can help. Contact us today at 1-800-692-8608.
Written by Terri Oppenheimer
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