LAUSR

Purpose: Blockade of immune checkpoint and angiogenesis is an effective treatment strategy for advanced or metastatic renal cell carcinoma (RCC). We report the results of camrelizumab plus famitinib in the RCC cohort of an open-label, multicenter, phase II basket study. Patients and Methods: Eligible patients were enrolled to receive camrelizumab (200 mg i.v. every 3 weeks) and famitinib (20 mg orally once daily). Primary endpoint was objective response rate (ORR) per RECIST version 1.1. Results: Totally, 38 patients were recruited, including 13 (34.2%) treatment-naïve and 25 (65.8%) previously treated patients. With a median duration from enrollment to data cutoff of 16.5 months (range, 6.1–20.4), 23 patients achieved a confirmed objective response, and ORR was 60.5% [95% confidence interval (CI), 43.4–76.0]. Responses in 18 (78.3%) responders were still ongoing, and Kaplan–Meier estimated median duration of response had not been reached yet (range, 1.0+–14.8+ months). Median progression-free survival (PFS) was 14.6 months (95% CI, 6.2–not reached). ORR was 84.6% (95% CI, 54.6–98.1) in treatment-naïve patients and 48.0% (95% CI, 27.8–68.7) in pretreated patients; median PFS had not been reached and was 13.4 months (95% CI, 4.1–not reached), respectively. Most common grade 3 or 4 treatment-related adverse events included proteinuria (18.4%), hypertension (18.4%), decreased neutrophil count (13.2%), palmar-plantar erythrodysesthesia syndrome (10.5%), and hypertriglyceridemia (10.5%). No treatment-related deaths occurred, and no new safety signals were observed. Conclusions: Camrelizumab plus famitinib showed potent and enduring antitumor activity in patients with advanced or metastatic RCC, both in treatment-naïve and previously treated population.