Core Viewpoint - The company has initiated a Phase 2 clinical trial for HLX43, a targeted PD-L1 antibody-drug conjugate, in patients with advanced non-small cell lung cancer (NSCLC) [1][2] Group 1: Clinical Trial Details - The Phase 2 clinical trial is an open-label, international, multicenter study aimed at evaluating the efficacy and safety of HLX43 in advanced NSCLC patients [1] - The study consists of two stages: the first stage focuses on dose exploration to select an appropriate dose for the second stage, which is a single-arm, multicenter Phase 2 clinical study [1] - The primary objective of the study is to assess the clinical efficacy of HLX43, with the main endpoint being the objective response rate (ORR) evaluated by a blinded independent central review committee (BICR) according to RECIST v1.1 criteria [1] Group 2: Clinical Data and Efficacy - Preliminary data from the Phase 1 clinical trial presented at the 2025 World Lung Cancer Conference (WCLC) showed HLX43 has a 37.0% ORR and an 87.0% disease control rate (DCR) in advanced solid tumors, particularly in NSCLC patients who have failed prior checkpoint inhibitors and chemotherapy [2] - In NSCLC patients who had previously received docetaxel as third-line or higher treatment, the ORR was 30.0% [2] - In the EGFR wild-type non-squamous NSCLC population, HLX43 demonstrated an ORR of 46.7%, with a confirmed ORR of 60.0% in patients receiving a 2.5 mg/kg dose [2] - Among patients with brain metastases, the confirmed ORR was 36.4% with a DCR of 100.0% [2] - The ORR for PD-L1 positive (TPS ≥ 1%) and PD-L1 negative (TPS < 1%) patients was 34.4% and 38.1%, respectively [2] Group 3: Market Context - As of the announcement date, there are no approved PD-L1 targeted antibody-drug conjugates available in the global market [3]
复宏汉霖(02696)：注射用HLX43(靶向PD-L1抗体偶联药物)用于治疗晚期非小细胞肺癌的国际多中心2期临床研究完成澳大利亚首例患者给药