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Immunotherapy may slow growth of relapsed mesothelioma
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CHICAGO — Nivolumab alone or in combination with ipilimumab demonstrated encouraging activity in patients with relapsed malignant pleural mesothelioma, according to results of the randomized, phase 2 IFCT-1501 MAPS2 trial presented at the ASCO Annual Meeting.
“Our findings suggest that immunotherapy may provide new hope to patients with relapsed mesothelioma,” Arnaud Scherpereel, MD, PhD, head of the pulmonary and thoracic oncology department at University Hospital of Lille in France, said in a press release. “This randomized phase 2 trial may be enough to support the use of immune checkpoint inhibitors in this setting, but it is too early to conclude whether nivolumab alone or in combination of nivolumab and ipilimumab is better.”
Malignant pleural mesothelioma is an aggressive and rare cancer typically associated with asbestos exposure. Incidence rates are increasing but outcomes remain poor. More than 50% of patients relapse within 6 months of stopping initial chemotherapy, and median survival is 13 to 15 months. No effective therapies exist for malignant pleural mesothelioma.
In the MAPS2 trial, Scherpereel and colleagues assessed the efficacy and safety of the anti–PD-L1 monoclonal antibody nivolumab (Opdivo, Bristol-Myers Squibb) with or without ipilimumab (Yervoy, Bristol-Myers Squibb), a CTLA-4 immune checkpoint inhibitor, in patients with histologically proven malignant pleural mesothelioma.
All patients had a performance status of 0 or 1, and all had relapsed after one or two prior therapies, including a pemetrexed–platinum doublet regimen.
Researchers randomly assigned patients 1:1 to 3 mg/kg nivolumab every 2 weeks, with or without 1 mg/kg ipilimumab every 6 weeks. Treatment continued until disease progression or unacceptable toxicity, with a maximum treatment duration of 2 years.
Disease control rate at 12 weeks by blinded independent central review served as the primary endpoint.
The final analysis included 125 patients (median age, 71.8 years; range, 32-88; 80% men); of these, 62 received the combination and 63 received nivolumab alone.
Scherpereel reported “good compliance” with treatment in both groups, with more than 70% completing six cycles.
Results showed disease control rates of 51.9% (95% CI, 38.5-65.2) among patients assigned the combination and 42.6% (95% CI, 29.4-55.8) among patients assigned nivolumab alone. Objective response rates reached 25.9% (95% CI, 14.2-37.6) in the combination group and 16.7% (95% CI, 6.7-26.6) in the nivolumab monotherapy group.
After median follow-up of 10.4 months (range, 10-11.1), preliminary survival data appeared promising in both groups. An intention-to-treat analysis showed median PFS of 5.6 months among those who received the combination regimen and 4 months among those treated with nivolumab alone.
Patients assigned the combination appeared more likely to experience adverse events (86.9% vs. 77.8%), as well as grade 3 or grade 4 toxicities (16.4% vs. 9.5%).
Three patients assigned the combination died of treatment-related events. These events included one metabolic encephalopathy, one fulminant hepatitis and one acute renal failure.
Several trials are underway to evaluate nivolumab and other immune checkpoint inhibitors as second- or third-line treatments for malignant pleural mesothelioma. Many other larger trials are investigating immune checkpoint inhibitors as initial treatment.
“This is sort of amazing that we are seeing the checkpoint inhibitors expanding beyond just melanoma or cancers we thought were susceptible,” Michael S. Sabel, MD, FACS, chief of the division of surgical oncology at University of Michigan and an ASCO expert, said during a press conference. “This is a great example how basic research in one cancer can expand across the field of oncology.” – by Melinda Stevens
Reference:
Scherpereel A, et al. Abstract LBA8507. Presented at: ASCO Annual Meeting; June 2-6, 2017; Chicago.
Disclosure: Scherpereel reports no relevant financial disclosures. Please see the abstract for a list of all other researchers’ relevant financial disclosures. Sabel reports no relevant financial disclosures.