Epacadostat Plus Pembrolizumab in Patients With Advanced Renal Cell Carcinoma
In pretreated patients with advanced renal cell carcinoma, the treatment combination of epacadostat plus pembrolizumab was generally well tolerated and active, according to preliminary phase I/II results from the ongoing ECHO-202/KEYNOTE-037 study presented by Primo Lara, Jr, MD, of the University of California Davis, at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 4515). The investigators consider these results a demonstration of both the safety and preliminary efficacy of this novel immunotherapeutic strategy in advanced renal cell carcinoma. A phase III study of this combination therapy in renal cell carcinoma is planned.
The study included 30 evaluable patients who had received prior antiangiogenic therapy and no prior checkpoint inhibitor therapy. Dose escalation in the phase I part of the trial did not identify a maximum tolerated dose. Epacadostat at 100 mg twice daily plus pembrolizumab at 200 mg every 3 weeks were selected for phase II cohort expansion studies.
For the 19 patients who had received no or 1 prior treatment, the objective response and disease control rates were 47% and 58%, respectively, compared with 0% and 36% in patients who had received at least 2 prior treatments. Grade 3 or higher treatment-related adverse events were reported in 15% of patients, resulting in treatment discontinuation in 2 patients.