For many years, the only approved systemic therapy for treating malignant pleural mesothelioma was cisplatin and pemetrexed combination therapy. The phase 2 DREAM study which involves durvalumab with chemotherapy, ended up resulting in a progression-free survival at six months. Additionally, combining the anti-PD-1 antibody nivolumab with the anti-CTLA-4 antibody ipilimumab improved survival for patients who were not previously treated, compared to chemotherapy.
Study
PrE0505 was a phase 2, single-arm study in which patients were administered durvalumab once every three weeks, combined with their regular dose of pemetrexed and cisplatin. The study took place from June of 2017 to June of 2018. 55 mesothelioma patients were enrolled in the study from 15 community and academic cancer centers across the United States. Everyone in the study was over 18 and all of them had unresectable malignant pleural mesothelioma. The median age of the patients was 68 years old and 82 percent of them were males. 75% of the tumors were of the epithelioid variety. The median overall survival for patients that participated in the study was 20.4 months, which was a lot longer than 12 months, which was the overall survival of the control group.
The symptoms most reported from the treatment were anemia, fatigue and nausea. Treatment-emergent adverse events of grade 3 or higher occurred in 65.5 percent of patients.
Based on results from the DREAM study and the PrE0505 study, a new study was developed called the phase 3PrE0506/DREAM3R trial. This trial compares the effects of durvalumab with chemotherapy compared to just chemotherapy. Those with epithelioid mesothelioma who were enrolled in the PrE0505 study survived longer than two years.
Inclusion Criteria
Other inclusion criteria for the PrE0505 trial included a variety of different elements. For instance, the patient had to have measurable disease, “defined as at least one lesion that can be accurately assessed at baseline by computed tomography or magnetic resonance imaging and is suitable for repeated assessment.” They also must have had a minimum of 15 unstained tumor samples available. They had to have had an ECOG performance status of 0 or 1, they had to sign an informed consent and they had to have adequate organ function. Additionally, the patient could not be pregnant, they must not have participated in another study of the last four weeks and they must not have received any systemic therapy to treat their mesothelioma in the past. These are just a sampling of the many criteria.
Patrick Forde, MBBCh, an Associate Professor of Oncology at the Johns Hopkins University School of Medicine reported the findings of the PrE0505 trial during the lung cancer oral abstract session at the ASCO20 Virtual Scientific Program. Once a patient had up to six cycles of a combination of durvalumab and chemotherapy, those who had a stable disease, or a partial response could keep going with the durvalumab on the first day of each three week cycle. The most a patient could be administered durvalumab was 12 months. Overall survival rates of the trial were 70.4 percent survival at 12 months and 44.2 percent survival at 24 months.
If eligible for a clinical trial, it may be something useful to look into for those who are victims of mesothelioma, a very rare and aggressive form of cancer that usually affects the lungs.
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