HLX43 received PMDA acknowledgment to initiate a global Phase 2/3 trial in squamous non-small cell lung cancer

CAR-T Digest - August 2020

06 May 2026: HLX43 received PMDA acknowledgment to initiate a global Phase 2/3 trial in squamous Non-Small Cell Lung Cancer

Henlius has achieved a key milestone for its anti-PD-L1 ADC HLX43, receiving PMDA acknowledgment to initiate the global Phase 2/3 HLX43-NSCLC302 trial in advanced sqNSCLC across China, the US, and Japan
The HLX43-NSCLC302 trial will compare HLX43 alone or in combination with HLX07 against docetaxel, positioning the program as a potential next-generation ADC approach in lung cancer treatment
HLX43 has gained attention for combining PD-L1 checkpoint blockade with ADC-driven cytotoxicity, with updated World Conference on Lung Cancer 2025 data showing a 40% ORR and 73.3% disease control rate in later-line sqNSCLC at the 2.0 mg/kg dose
The study addresses a major unmet need in sqNSCLC, where patients progressing after first-line immunotherapy still have limited options and often rely on docetaxel-based treatment with poor later-line outcomes
Henlius is also advancing a differentiated combination strategy with its anti-EGFR antibody HLX07, supported by early data showing strong response rates in EGFR-overexpressing sqNSCLC and reinforcing the rationale for dual-targeted approaches