Dr. Raffit Hassan of the National Cancer Institute, and former chair of the Mesothelioma Applied Research Foundation’s Science Advisory Board, announced results of the Phase 1 clinical trial of avelumab at the most recent ASCO (American Society of Clinical Oncology) meeting in Chicago.
Avelumab, an anti-PD-L1 antibody, works on the basis of boosting the immune system. PD-1 inhibitors have already shown great promise in melanoma, renal cell carcinoma and lung cancer, demonstrating both tumor shrinkage and durable responses.
The study included 53 patients with pleural and peritoneal mesothelioma.
The main goal of this study was to determine a safe dosage, and overall assess the safety of the drug. In this case, identified side-effects were mostly minor and included infusion-related reaction, fatigue, and fever. In 7.5% of patients, more serious side-effects were identified, including 1 patient with colitis.
The analysis of the response of patients in the study yielded the following:
- Objective response rate (ORR) was 9.4%, with five partial responses (four confirmed);
- response was ongoing in four of five of those patients;
- the median duration of response was not reached;
- 25 patients had stable disease (47.2%), and the disease control rate was 56.6%;
- the median progression-free survival (PFS) was 17.1 weeks; at 24 weeks, the PFS rate was 38.4%.
The study had no treatment-related deaths.
“Though it was a negative study, there is a role for PD-L1 inhibitors in mesothelioma. We will soon begin to see new combinations surface that combine PD-L1 inhibitors with other agents,” said Mary Hesdorffer, NP, Executive Director, Mesothelioma Applied Research Foundation.