Durvalumab Phase III Trial Could Change Mesothelioma Care

An international, much-anticipated phase III clinical trial that could change standard-of-care treatment for patients with malignant pleural mesothelioma will open soon, pending COVID-19 pandemic restrictions.

The randomized trial will be studying the effectiveness of the immunotherapy drug durvalumab (Imfinzi) when used in combination with chemotherapy drugs pemetrexed (Alimta) and cisplatin for mesothelioma.

Opening dates may vary by center because of the COVID-19 pandemic that has slowed or stalled clinical trials everywhere.

Durvalumab produces an antibody that helps a patient’s own immune system kill tumor cells by negating the PD-L1 protein that often blocks it from happening.

The protein typically allows tumor cells to avoid a patient’s immune system.

Durvalumab, which is marketed as Imfinzi by the multinational biopharmaceutical company AstraZeneca, was approved by the FDA in 2017 for bladder cancer and has shown early effectiveness with certain lung cancers.

The mesothelioma clinical trial, in a first-line setting for patients who are not surgical candidates, is known officially as DREAM3R. Patients will be randomized 2-to-1 to receive durvalumab with chemotherapy or standard chemotherapy alone.

“We need more data to reach any conclusions,” trial investigator Dr. Bernardo Goulart at the Seattle Cancer Care Alliance told The Mesothelioma Center at Asbestos.com. “But earlier results have been promising. Chemotherapy with immunotherapy may become the new standard of care. We’re making progress.”

Phase II Durvalumab Study Posts Significant Results

The elevated study was sparked by the positive results from phase II, which will be detailed at the American Society of Oncology virtual annual meeting May 29-31.

Median overall survival in phase II was 20.4 months, almost double the historical control of 12.1 months with standard chemotherapy, according to a press release from PrECOG LLC, the cancer research group sponsoring the study for AstraZeneca.

Overall survival rates at 12 and 24 months were 70.4% and 44.2%. The six-month progression-free survival was 69.1%.

The study included 55 patients enrolled at 15 clinical sites within the U.S. from June 1, 2017, to June 2018. Results also included 31 patients with partial responses and 22 with stable disease. All patients were evaluated for safety and no unexpected toxicities were reported.

Durvalumab Study Patient To Pass Three-Year Survival Mark

Goulart said one of his five patients at the Seattle Cancer Care Alliance will be passing the three-year survival mark next month.

“I think they did reasonably well overall, better than expected for this disease,” he said. “But until the randomized trial, you really don’t know the benefits for sure.”

Seattle Cancer Care Alliance, which will be part of the phase III trial, includes both the Fred Hutchinson Cancer Research Center and the University of Washington Medical Center. It has accelerated its role as a mesothelioma specialty center in recent years.

Leading Specialty Centers Involved in Durvalumab Clinical Trial

Also expected to be part of the trial are Johns Hopkins Sidney Kimmel Cancer Center in Baltimore; Stanford Cancer Institute in Palo Alto, California; Fox Chase Cancer Center in Philadelphia and the University of Chicago Comprehensive Cancer Center.

Patients in the upcoming trial will receive durvalumab with chemotherapy every three weeks for up to six cycles, followed by maintenance with durvalumab every four weeks.

“This is a remarkable result in mesothelioma,” said Dr. Peter O’Dwyer, chief executive officer at PrECOG LLC. “It warrants confirmation in a randomized phase III trial.”

Durvalumab is part of eight different clinical trials in various phases and combinations involving mesothelioma.

The Lung Institute at Baylor College of Medicine in Houston has been studying its effectiveness in combination with surgery, both as a single agent and alongside tremelimumab, another immunotherapy drug.

Dana-Farber Cancer Institute in Boston is studying it for second-line treatment with tremelimumab.

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