This morning, Arnaud Scherpereel, MD, PhD, head of the Pulmonary and Thoracic Oncology Department at the University Hospital of Lille in France, presented the results of the IFCT-1501 MAPS-2 clinical trial at the American Society of Clinical Oncology (ASCO) Annual Meeting. The study was sponsored by the French Cooperative Thoracic Intergroup (IFCT) with drugs and a research grant supplied by Bristol-Myers Squibb (BMS).
The multicenter, randomized phased II clinical trial evaluated the efficacy and safety of 2nd and 3rd line treatment for malignant pleural mesothelioma patients in two arms. Patients in the monotherapy arm were administered nivolumab alone. Patients in the combination arm were administered nivolumab plus ipilimumab.
Nivolumab and ipilimumab are immunotherapy drugs known as immune checkpoint inhibitors, targeting PD-1 and CTLA-4, respectively. In simple terms, these drugs work to allow the immune system to attack cancer cells. Both drugs have shown promise in the treatment of other types of cancer, most notably melanoma.
The study included 125 patients with proven unresectable malignant pleural mesothelioma. All participating patients had previous treatment by 1 or 2 systemic chemotherapy lines, including at least first-line treatment with pemetrexed and cisplatin or carboplatin.
The clinical trial yielded the following results:
- Disease control rate (DCR) at twelve weeks was 44.4% with nivolumab alone and 50% with nivolumab plus ipilimumab
- Objective response rate was 18.5% with nivolumab alone and 25.9% with nivolumab plus ipilimumab
- Median overall survival was 10.4 months with nivolumab alone and not reached for the combo arm
- Progression-free survival was 4.0 months with nivolumab alone and 5.6 months for the combo arm
- Toxicities were slightly increased in the combo arm vs nivolumab alone
- 3 treatment-related deaths were observed in the combo arm (1 metabolic encephalopathy, 1 fulminant hepatitis, 1 acute renal failure)
“The results of IFCT-1501 MAPS-2 study, showing the efficacy and safety of nivolumab alone or in combination with ipilimumab, are promising, and additional research is needed for patients with relapsed mesothelioma,” said Dr. Scherpereel in a statement to BMS.
Currently, there is no recommended treatment in malignant pleural mesothelioma patients progressing after first-line treatment with pemetrexed and platinum. The DCR is <30% with all drugs previously tested in the 2nd line setting. In this study, both arms of treatment reached their endpoint with favorable DCR reported, suggesting that immunotherapy may provide new options for 2nd and 3rd line treatment for malignant pleural mesothelioma patients.