TQ-B2450 is a novel humanized antibody, blocking programmed death-ligand 1. This study is to investigate the efficacy and safety of TQ-B2450 alone/with anlotinib, an oral multi-target tyrosine kinase inhibitor approved as ≥ 3 lines treatment in advanced NSCLC in China, in advanced/metastatic NSCLC patients (pts) without driver gene mutations.
This is a multicenter, randomized, double-blind, placebo-controlled study (NCT03910127). Eligible pts were ≥ 18 years old with ≥1 measurable lesion defined by RECIST v1.1, and had received at least first-line of standard chemotherapy but failed or intolerable, and were EGFR/ALK wild type IIIB-IV stage NSCLC. All pts were randomized in a 1:1:1 ratio to receive TQ-B2450 (1200mg IV on Day 1 Q21D) plus placebo, TQ-B2450 (1200mg IV on Day 1 Q21D) plus anlotinib (10 mg QD from day 1 to 14 of a 21-day cycle) or TQ-B2450 (1200mg IV on Day 1 Q21D) plus anlotinib (12 mg QD from day 1 to 14 of a 21-day cycle) until disease progression or treatment intolerance. The primary endpoint was PFS, secondary endpoints included safety, ORR, DCR and OS.
Between July. 2019 and March. 2021, 33 and 68 pts in TQ-B2450 alone group and TQ-B2450 plus anlotinb group (average daily exposure dosage of anlotinb was 10.2 mg) were enrolled receptively. Baseline characteristics were generally balanced between groups. As of Oct 14, 2021, median follow up was 11.1 months. Median PFS was significantly longer in TQ-B2450 plus anlotinb group (6.9 months [95% CI 5.3-12.4]) than in TQ-B2450 alone group (2.7 months [95% CI 1.4-4.7]) (HR 0.43, 95% CI 0.25-0.73; P=0.0014). OS data were immature and not formly tested. ORR was significantly higher in TQ-B2450 plus anlotinb group than in TQ-B2450 alone group (30.9% vs. 3.0%, P=0.0043). Adverse events of ≥ grade 3 occurred in 67.7% of the pts in TQ-B2450 plus anlotinb group and in 21.2% of those in TQ-B2450 alone group.
A significantly and clinically meaningful improvement in PFS with TQ-B2450 plus anlotinib versus TQ-B2450 alone in all patients, supporting TQ-B2450 plus anlotinib as a promising treatment for advanced/metastatic NSCLC pts with prior systemic therapy.
NCT03910127.
All authors have declared no conflicts of interest.