Background: This study aimed to evaluate the efficacy and safety of KN046, a novel recombinant humanized antibody targeting PD-L1 and CTLA-4 in advanced non-small cell lung cancer (NSCLC) patients after failure or intolerance to platinum-based chemotherapy. Methods: In this multi-center, open-label phase II clinical trial, patients were enrolled after failure or intolerance to platinum-based chemotherapy. KN046 at 3 mg/kg or 5 mg/kg was administered intravenously every two weeks. The primary endpoint was objective response rate (ORR) evaluated by a blinded independent review committee (BIRC). Results: A total of 30 and 34 patients were included in the 3 mg/kg (cohort A) and 5 mg/kg (cohort B) cohorts. On August 31, 2021, the median follow-up duration was 24.08 months (interquartile [IQR], 22.28, 24.84) and 19.35 months (IQR, 17.25, 20.90) in the 3 mg/kg and 5 mg/kg cohorts, respectively. BIRC-assessed ORRs were 13.3% and 14.7% in the 3 mg/kg and 5 mg/kg cohorts, respectively. Median progression-free survival (PFS) were 3.68 (95%CI 3.22-7.29) and 3.68 (95%CI 1.81-7.39) months, while overall survival (OS) were 19.70 (95.5%CI 15.44-not estimated [NE]) and 13.04 (95.5%CI 9.86-NE) months, respectively. The most common treatment-related adverse events (TRAEs) were anemia (28.1%), hyperglycemia (26.7%), and infusion-related reactions (26.7%). The incidence rates of grade ≥3 TRAEs and TRAEs leading to treatment discontinuation were 42.2% and 14.1%, respectively. Conclusions: Both 3 mg/kg and 5 mg/kg KN046 showed promising efficacy and favorable safety profile for advanced NSCLC after failure or intolerance to previous platinum-based chemotherapy.

European Journal of Cancer

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