HENLIUS (02696) has announced that the National Medical Products Administration (NMPA) has approved its clinical trial application for HLX43, a PD-L1-targeting antibody-drug conjugate (ADC), used in combination with bevacizumab, with or without chemotherapy, for the treatment of advanced or metastatic solid tumors. The company plans to initiate the relevant clinical trials in mainland China once conditions are met.
HLX43 is an ADC developed by HENLIUS through the conjugation of a novel DNA topoisomerase I inhibitor small-molecule toxin-peptide linker, licensed from a third party, with the company's self-developed PD-L1-targeting antibody. It is intended for the treatment of advanced or metastatic solid tumors. Key subgroup data from the HLX43 study in non-small cell lung cancer (NSCLC) were presented as an oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting.
This presentation was based on a pooled analysis of NSCLC patients from the first-in-human Phase 1 study (HLX43-FIH101) and the global multi-center Phase 2 study (HLX43-NSCLC201). For the first time, overseas patient data were included, key efficacy endpoints were assessed by blinded independent central review (BICR), and progression-free survival (PFS) data were disclosed. As of February 28, 2026, the study enrolled 205 patients with advanced NSCLC, of whom 99.0% had received prior platinum-based chemotherapy, 82.0% had prior immunotherapy, 41.0% had prior targeted therapy, and 24.4% had prior docetaxel treatment. Nearly 40% of patients had received three or more prior lines of therapy. Additionally, 27.8% of patients had bone metastases, and 13.7% each had brain or liver metastases, indicating a heavily pretreated patient population with a high disease burden.
In EGFR wild-type non-squamous NSCLC (nsNSCLC) patients treated at the 2.5 mg/kg dose (n=19), HLX43 monotherapy achieved a confirmed objective response rate (cORR) of 36.8%, a confirmed disease control rate (cDCR) of 94.7%, and a median progression-free survival (mPFS) of 6.67 months. In squamous NSCLC (sqNSCLC) patients with prior docetaxel failure treated at the 2 mg/kg dose (n=33), HLX43 monotherapy showed a cORR of 33.3% and an mPFS of 6.34 months. Among sqNSCLC patients with prior docetaxel failure who had received three or more prior lines of therapy (2 mg/kg, n=15), HLX43 monotherapy yielded a cORR of 46.7%, a cDCR of 80.0%, and an mPFS of 6.90 months, which significantly outperformed historical response rates for this population treated with conventional chemotherapy (docetaxel).
Furthermore, in PD-L1-positive (TPS≥1%, n=29) and PD-L1-negative (TPS<1% or not evaluable, n=39) patients, HLX43 treatment resulted in cORR of 37.9% and 33.3%, respectively, and cDCR of 89.7% and 84.6%, respectively, showing no significant difference. The mPFS was 6.80 months in the PD-L1-positive subgroup and 5.49 months in the PD-L1-negative subgroup. These results indicate that HLX43 provides a consistent and effective treatment option regardless of PD-L1 expression status. Regarding safety and tolerability, it is noteworthy that across the 205-patient analysis population, which included various dose levels, NSCLC subtypes, and treatment backgrounds, HLX43 demonstrated a generally consistent and favorable safety profile.
Comments