China-based Hengrui Pharmaceuticals has announced that its investigational HER3-targeted antibody-drug conjugate (ADC), ruzaltatug rezetecan, met the primary endpoint of progression-free survival (PFS) in a Phase III trial. The study enrolled 498 patients with EGFR-mutated non-small cell lung cancer (NSCLC) who had failed prior EGFR inhibitor therapy. In the randomised, open-label trial, ruzaltatug rezetecan demonstrated a statistically significant improvement in PFS compared to platinum-based doublet chemotherapy, as assessed by blinded independent central review (BICR).

Ruzaltatug rezetecan is a fully human HER3 monoclonal antibody (mAb) conjugated to a DNA topoisomerase I (Top I) inhibitor payload. The company plans to submit a pre-New Drug Application (NDA) communication to China’s Centre for Drug Evaluation (CDE) in the near term. This positive readout positions Hengrui as a leader in the global HER3 ADC space, with the asset also advancing into Phase III trials for first-line EGFR-mutated NSCLC.

PharmCube's NextBiopharm® database shows that the only HER3 ADC that outpaces ruzaltatug rezetecan's development is MSD's patritumab deruxtecan, which is currently under review. Click here to request a free trial for NextBiopharm®.