Abstract CT200: Updated PFS & OS from the phase Ib study of TQB2450 alone/with Anlotinib in previously treated advanced non-small cell lung cancer
Authors: Han Baohui , Li Kai , Wang Qiming , Cheng Ying , Yang Lei , Li Yueming 
Published: April 2023

Abstract
Background: At the interim analysis (data cutoff Oct 14, 2021) of this study (NCT03910127), TQB2450 plus anlotinb group significantly improved mPFS versus TQB2450 alone in chemotherapy treated patients with advanced NSCLC without driver gene alterations (6.9 months vs 2.7 months). We report an updated PFS, OS and safety results for this study.
Method: This is a multicenter, randomized, double-blind, phase Ib study. Adult patients with histologically or cytologically-confirmed stage IIIB or IV NSCLC who had wild-type EGFR/ALK and at least one line of prior systemic therapy or being intolerable of chemotherapy were randomized 1:1:1 to receive TQB2450 1200 mg plus placebo, or anlotinib 10 or 12 mg. The primary end point was PFS and secondary endpoints included safety and OS.
Results: Between July. 2019 and March. 2021, 101 pts were enrolled. 33 patients were randomly assigned to TQB2450 plus placebo and 68 patients to TQB2450 plus anlotinib. As of 19 September 2022, The median follow-up was 26.3 months. The median PFS (7.3 months, 95% CI 5.3-11.0) for TQB2450 plus anlotinib was significantly longer than that for TQB2450 plus placebo group (2.8 months, 95% CI 1.4-4.7) (HR 0.39, 95% CI 0.23-0.64; P=0.0001) (Table). In patients with PD-L1 ≥ 1%, the mPFS was 17.9 months (95% CI 5.8-31.1) in TQB2450 plus anlotinib 12 mg, which was numerically higher than that in TQB2450 plus anlotinib 10 mg. The median OS of patients with PD-L1 ≥ 1% for TQB2450 plus anlotinib 12 mg was numerically higher than that in TQB2450 plus anlotinib 10 mg (32.2 months vs 21.8 months). Grade 3 or higher TRAEs occurred in 50.0% of the patients in TQB2450 plus anlotinb and in 12.1% of those in TQB2450 plus placebo.
Conclusions: In this updated analysis with longer follow-up, TQB2450 combined with anlotinib continues to demonstrate overall efficacy and manageable safety profiles in chemotherapy treated patients with advanced NSCLC without driver gene mutations.
TQB2450 TQB2450+Anlotinib 10mg TQB2450+Anlotinib 12mg TQB2450+Anlotinib mPFS n 33 34 34 68 Censor, n (%) 7 (21.2) 9 (26.5) 8 (23.5) 17 (25.0) Median (95%CI) 2.8 (1.4-4.7) 7.0 (4.5-14.5) 8.7 (4.1-11.4) 7.3 (5.3-11.0) HR (95%CI) 0.37 (0.21-0.66) 0.40 (0.22-0.70) 0.39 (0.23-0.64) P value 0.0006 0.0001 mPFS (PD-L1≥1%) n 19 19 19 38 Censor, n (%) 3 (15.8) 6 (31.6) 7 (36.8) 13 (34.2) Median (95%CI) 2.1 (1.3-7.2) 7.0 (2.1-19.4) 17.9 (5.8-31.1) 8.6 (5.3-22.8) HR (95%CI) 0.35 (0.16-0.77) 0.29 (0.13-0.64) 0.32 (0.16-0.63) P value 0.0023 0.0006 mOS n 33 34 34 68 Censor, n (%) 12 (36.4) 14 (41.2) 12 (35.3) 26 (38.2) Median (95%CI) 15.3 (6.6-20.5) 20.6 (8.6-25.8) 14.7 (10.0-32.2) 17.9 (10.5-23.2) HR (95%CI) 0.78 (0.42-1.44) 0.84 (0.46-1.53) 0.81 (0.48-1.37) P value 0.7157 0.4329 mOS (PD-L1≥1%) n 19 19 19 38 Censor, n (%) 5 (26.3) 7 (36.8) 8 (42.1) 15 (39.5) Median (95%CI) 15.7 (7.8-21.0) 21.8 (7.1-NR) 32.2 (14.2-33.6) 21.8 (14.2-33.6) HR (95%CI) 0.72 (0.33-1.58) 0.63 (0.28-1.40) 0.67 (0.34-1.32) P value 0.4900 0.2479
Citation Format: Baohui Han, Kai Li, Qiming Wang, Ying Cheng, Lei Yang, Yueming Li. Updated PFS & OS from the phase Ib study of TQB2450 alone/with Anlotinib in previously treated advanced non-small cell lung cancer [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 2 (Clinical Trials and Late-Breaking Research); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(8_Suppl):Abstract nr CT200.