Shanghai Henlius Biotech, Inc. (Henlius) has administered the first dose to a patient in Spain—its initial enrolment within the European Union—in an international, multicentre Phase 2 study evaluating HLX43, an antibody-drug conjugate (ADC) targeting PD-L1, for the treatment of advanced non-small cell lung cancer (NSCLC). The trial is concurrently recruiting in Mainland China, the United States, Australia and Japan.
The open-label study comprises two parts. Part 1 explores dosage levels to establish the recommended Phase 2 dose, while Part 2 is a single-arm efficacy expansion. The primary study endpoint is objective response rate (ORR) assessed by Blinded Independent Central Review under RECIST v1.1 criteria.
HLX43 links a company-developed anti-PD-L1 antibody to a licensed peptide linker carrying a novel DNA topoisomerase I inhibitor payload. Development spans multiple tumour types: • Advanced/metastatic solid tumours – Phase 1 in Mainland China, Phase 1 in Japan and authorised Phase 1 start in the United States • Advanced NSCLC – current Phase 2 international trial • Metastatic colorectal cancer, cervical cancer and esophageal squamous cell carcinoma – Phase 2 trials in Mainland China • Combination regimens with cetuximab biosimilar HLX07 or anti-PD-1 HANSIZHUANG – ongoing Phase 1b/2 studies in Mainland China and authorised Phase 2/3 study in Japan for squamous NSCLC
Key data disclosed from earlier trials highlight encouraging activity and tolerability: • Phase 1 (multiple solid tumours, median ≥3 prior lines): investigator-assessed ORR 37.00% and disease control rate 87.00% in NSCLC. • Phase 2 cervical cancer: overall ORR 41.40%, increasing to 70.00% at the 3.0 mg/kg dose. • Phase 2 esophageal squamous cell carcinoma: overall ORR 30.30%, rising to 61.50% at 3.0 mg/kg.
According to the company, no PD-L1–targeting ADC has yet secured marketing approval worldwide, underscoring a potentially large unmet medical need should HLX43 succeed. Henlius cautions that clinical development remains subject to inherent risks and there is no guarantee of eventual regulatory approval or commercialisation.
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