The American Society of Clinical Oncology (ASCO) Annual Meeting held June 3–7, 2016, in Chicago, IL. was the site of the presentation of 14 abstracts on preliminary results of a Phase I clinical trial of avelumab across seven different tumor types. Dr. Raffit Hassan of the National Cancer Institute presented the data from the study in patients with advanced unresectable mesothelioma.
The JAVELIN clinical trial, with an anticipated completion date of May 2018, is designed to determine the safety, tolerability, and appropriate dosage of avelumab for cancer patients. Of the 1,600 patients currently enrolled in the study, Dr. Hassan reported on the results of 53 patients with unresectable pleural or peritoneal mesothelioma who had progressed after a platinum/pemetrexed-containing regimen, according to a June 6 article in Cancer Network.
Avelumab, (also known as MSB0010718C), is an investigational immunotherapy drug that targets the PD-L1 protein. The drug works by blocking signals from PD-L1 tumors, activating the immune system, allowing it to take over and attack and kill cancer cells. Merck KGaA, Darmstadt, Germany, and Pfizer have formed a strategic alliance to co-develop and co-commercialize the drug.
Dr. Hassan reported the key findings in the mesothelioma population including: the disease control rate of 56.6%; the median progression-free survival (PFS) was 17.1 weeks; at 24 weeks, the PFS rate was 38.4%. Among the 14 PD-L1–positive patients, PFS was 17.1 weeks compared to 7.4 weeks in the PD-L1–negative patients. The drug was generally well tolerated. The patients were not tested for PD-L1 prior to acceptance into the trial.
“Ongoing follow-up will further characterize durability of the clinical benefit,” said Dr. Hassan. “This dataset is the largest study to date of patients with mesothelioma treated with an anti–PD-1 or anti–PD-L1 antibody.”
Pleural mesothelioma, a rare form of cancer affecting the lining of the lungs, is highly aggressive and is resistant to many cancer treatments making it a difficult disease to treat effectively. Recent breakthroughs in the use of immunotherapy drugs, such as Keytruda, another immunotherapy drug targeting PD-L1, have brought new hope to the mesothelioma community with several mesothelioma warriors showing excellent results from use of the drug. This study could bring another PD-L1 inhibitor option to mesothelioma patients.
“Through our comprehensive JAVELIN clinical development program for avelumab, we are making meaningful advances for a broad range of patients with cancer,” said Chris Boshoff, M.D., PhD., Vice President and Head of Early Development, Translational and Immuno-Oncology at Pfizer Oncology, in a May 18 press release.
“Though it was a negative study, there is a role for PD-L1 inhibitors in mesothelioma,” said Mary Hesdorffer, NP, Executive Director, Mesothelioma Applied Research Foundation in a June 6 press release announcing the findings.
For more information about the JAVELIN clinical trial see ClinicalTrials.gov.