A promising immunotherapy drug for mesothelioma is entering the most important phase of the FDA approval process.
The upcoming phase 3 DREAM3R clinical trial presents durvalumab as an option for malignant pleural mesothelioma. After success in the first two phases, doctors plan to enroll around 480 participants. The study locations include United States hospitals, along with Australia and New Zealand.
The U.S. hospitals are:
- Michigan Medicine (the University of Michigan)
- Metro Minnesota Community Oncology Research Consortium
If you’d like to enroll in this trial, please contact our patient advocate and registered nurse, Karen Ritter. She can be reached at firstname.lastname@example.org. Even if you’re not eligible for this study or it’s too far from where you live, Karen can help you pick from a list of other recruiting mesothelioma clinical trials.
How Does Durvalumab Work?
Durvalumab is a generic checkpoint inhibitor immunotherapy drug, often acknowledged by the brand name Imfinzi. It explicitly stifles the PD-L1 protein on mesothelioma cells, disrupting its link with the PD-1 receptor on T-cells.
Durvalumab is similar to Opdivo, the brand name for nivolumab. Opdivo is a PD-L1 checkpoint inhibitor that the U.S. Food and Drug Administration approved for malignant mesothelioma in 2020.
Durvalumab is close to the same status.
What Is the DREAM3R Clinical Trial?
The DREAM3R study is the merging of two phase 2 trials: DREAM and PrE0505. Both tested adding durvalumab to chemotherapy treatment, creating a chemoimmunotherapy regimen. The idea is chemotherapy and immunotherapy for mesothelioma perform better together than alone.
Both studies had success, proving that durvalumab plus chemotherapy works better than chemotherapy alone:
- PrE0505 ended with a median survival of 20.4 months for durvalumab plus chemotherapy. Historically, chemotherapy alone only has a median survival of one year.
- The PrE0505 study had a 44% two-year survival rate, which far exceeds chemotherapy.
- The DREAM study ended with 57% of patients progression-free after six months.
The phase 3 study will randomize the 400-plus participants in a 2-to-1 ratio. Most will receive durvalumab plus chemotherapy. One-third will receive just chemotherapy.
The first group will receive durvalumab every three weeks and chemotherapy every three weeks for 4-6 cycles. Following the regimen, they’ll receive maintenance durvalumab every four weeks to prevent recurrence.
The second group will receive chemotherapy every three weeks for 4-6 cycles.
Sources & Author
- Phase 3 DREAM3R trial opens for malignant pleural mesothelioma. Medical News. Retrieved from: https://www.news-medical.net/news/20210317/Phase-3-DREAM3R-trial-opens-for-malignant-pleural-mesothelioma.aspx. Accessed: 03/19/2021.
- DuRvalumab With chEmotherapy as First Line treatment in Advanced Pleural Mesothelioma (DREAM3R). Clinicaltrials.gov. Retrieved from: https://clinicaltrials.gov/ct2/show/NCT04334759. Accessed: 03/19/2021.
Sources & Author