CHICAGO – Early data from a phase II trial of immune checkpoint inhibitors to treat relapsed mesothelioma give hope that immunotherapy may be an effective therapeutic option for the rapidly progressive, currently incurable cancer.
Reporting on 12 weeks of data from the randomized multicenter trial, Arnaud Scherpereel, MD, the study’s first author, said in a video interview, “We were very pleased to see that we were able to increase ... the disease control rate to 44% with nivolumab, and 50% with nivolumab plus ipilimumab. This was translated into a overall survival gain for these patients.” The best previous disease control rate seen with other therapies was less than 30%, said Dr. Scherpereel at the annual meeting of the American Society of Clinical Oncology.
Discussing the early results in a video interview, Dr. Scherpereel, head of the pulmonary and thoracic oncology department at the University Hospital of Lille, France noted that the median overall survival for the nivolumab patients was 10.4 months, and has not yet been reached for the nivolumab plus ipilimumab patients. Further, he said in a press briefing, “Tumors shrunk in 18% of patients treated with nivolumab and 26% of those treated with nivolumab plus ipilimumab.”
The French MAPS-2 study has enrolled 125 adult patients with malignant pleural mesothelioma who had measurable disease progression after one or two prior lines of chemotherapy, including pemetrexed/platinum doublet. Patients were randomized 1:1 to receive either nivolumab or nivolumab plus ipilimumab, until disease control or unacceptable toxicity was reached, for a maximum of 2 years. Patients were mostly (80%) male, with a median age of 71.8 years, and most had the epithelioid malignant pleural mesothelioma subtype.
In commentary at the press briefing announcing the findings, ASCO expert Michael Sabel, MD, said, “I need to emphasize that this is amazing, in that we are seeing [the use of] checkpoint inhibitors expanding beyond melanoma, to other cancers that we thought were not amenable to immunotherapy approaches.”
“This is a great example of how basic cancer research in one field can expand across others,” said Dr. Sabel of the departments of surgery and surgical oncology at the University of Michigan, Ann Arbor.
Most side effects were not severe, but there were three potentially drug-related deaths in the nivolumab-ipilimumab combo arm: one patient died of fulminant hepatitis, one from metabolic encephalitis, and one from acute renal failure. “There is no identified factor that is predictive” in terms of which patients will have the more significant known adverse effects of checkpoint inhibitors, said Dr. Scherpereel. Patients, caregivers, and health care professionals all need to be alert to the possibility of adverse events and act promptly if concerning symptoms crop up, he said.
Dr. Scherpereel said that though his study group has not yet reported the quality of life findings from MAPS-2, he sees that his patients who are study participants are doing better. “In my patients, they have a very good tolerance to this treatment compared to chemotherapy. They have less dyspnea, less chest pain. Clearly, we hope to get these drugs into the routine very quickly for them.”
Bristol-Myers Squibb manufactures both nivolumab and ipilimumab and provided the study drugs. Dr. Sabel disclosed a financial relationship with Merck. Dr. Scherpereel has no relevant financial disclosures.
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