CM082 Plus Everolimus in Pretreated Metastatic Renal Cell Carcinoma
In pretreated patients with advanced renal cell carcinoma, CM082, an oral multikinase inhibitor designed to lower toxicity and enable combination with other therapies, was well tolerated when administered at a dose of 200 mg in combination with everolimus at 5 mg. This phase I clinical research was presented by Xinan Sheng, MD, of Beijing Cancer Hospital, at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 4575).
A total of 22 patients were treated at 3 dose levels of CM082—100 mg (n=4), 150 mg (n=3), and 200 mg (n=15)—in combination with everolimus at 5 mg. Dose-limiting toxicity was observed in one patient, and CM082 at 200 mg plus everolimus at 5 mg was chosen as the optimal biologic dose regimen. Partial responses were observed in 36% of patients, and durable stable disease (≥ 24 weeks) or partial response was achieved in 71% of patients.
The most common treatment-related adverse events (all grades) were proteinuria (96%), leukopenia (77%), neutropenia (59%), hypercholesterolemia (64%), anemia (50%), hypertension (46%), increased aspartate aminotransferase (41%), fatigue (45%), diarrhea (32%), hypertriglyceridemia (32%), and thrombocytopenia (20%).
“The preliminary efficacy [of CM082 in combination with everolimus] warrants further evaluation, and the follow-up phase II/III study is underway,” the investigators concluded.