Henlius doses first patient in HLX43 lung cancer study

Shanghai Henlius Biotech, Inc. (HKEX:2696) has announced the dosing of the first patient in an international multicentre Phase 2 clinical study of HLX43, an anti-PD-L1 antibody-drug conjugate, for treating advanced NSCLC in mainland China. The open-label study aims to evaluate the efficacy and safety of HLX43 in NSCLC patients, consisting of a dose exploration phase followed by a single-arm Phase 2 trial, with the primary objective of evaluating the clinical efficacy through objective response rate (ORR) assessed by Blinded Independent Central Review (BICR). HLX43, developed by Henlius, combines a novel DNA topoisomerase I inhibitor payload with an anti-PD-L1 antibody. The announcement cautions that the successful development and commercialization of HLX43 are not guaranteed.