A phase 2 immunotherapy clinical trial combining durvalumab, an immunotherapy drug, with standard treatment of Alimta (pemetrexed)/cisplatin has shown promising overall survival results.
The study enrolled 55 patients and showed a median survival of 20.1 months. Of those 55 patients, 31 demonstrated a partial response, and 22 had stable disease. Most frequently observed adverse events included fatigue, nausea, anemia, and constipation – all which are typically seen with platinum-based chemotherapy. Among adverse events that investigators thought were possibly related to immunotherapy are hypothyroidism and rashes.
On Friday, May 29, 2020, the full results of the “PrE0505: Phase II multicenter study of anti-PD-L1, durvalumab, in combination with cisplatin and pemetrexed for the first-line treatment of unresectable malignant pleural mesothelioma (MPM)—A PrECOG LLC study” were reported on at the annual American Society of Clinical Oncology’s (ASCO) virtual meeting.
ASCO’s annual meeting is an important gathering where research updates are shared among its membership of over 45,000 oncologists. This year’s meeting, though virtual (and not in person), is especially valuable as other similar meetings had to be canceled.
Previously, a similar study out of Australia led by Anna Nowak, MD, PhD, a medical oncologist and researcher from the University of Western Australia, also reported similarly positive results. Read more about the DREAM study here.
A phase 3 trial combining the U.S. and Australian groups (PrE0506/DREAM3R) will commence later this year. That trial was delayed due to the COVID-19 pandemic.
The principal investigator of this study is Dr. Patrick Forde of Johns Hopkins, who is also a member of the board of the Mesothelioma Applied Research Foundation.
“I am delighted to present the results of PrE0505 at ASCO and I would like to thank the patients and families who participated across the United States. The PrE0505 trial examined the role of durvalumab immunotherapy combined with standard chemotherapy for newly diagnosed mesothelioma patients. The results show a promising overall survival for the combination treatment, and PrECOG is planning to evaluate the results further in a phase 3 trial with colleagues from Australia.”
Dr. Patrick Forde
His Australian counterpart, Dr. Nowak, is a previous recipient of a Meso Foundation research grant. Her project seeks to identify biomarkers that will help differentiate responders from non-responders prior to the administration of treatment. The study is an extension of the previously mentioned DREAM trial which enrolled 54 patients treated with Alimta (pemetrexed)/cisplatin (standard chemotherapy for mesothelioma) and durvalumab (a PD-L1 inhibitor).
The Mesothelioma Applied Research Foundation is the only 501(c)(3) nonprofit organization working to eradicate mesothelioma and end this national tragedy. Its programs include the funding of promising and peer-reviewed research, education, support and advocacy. The organization strives to bring together thought-leaders in the field to identify the most direct path to a cure.
