Hengrui announces phase 3 trial of HER3 ADC SHR-A2009 for EGFR-mutant advanced NSCLC met primary endpoint of PFS

CAR-T Digest - August 2020

19 May 2026: Hengrui announces phase 3 trial of HER3 ADC SHR-A2009 for EGFR-mutant advanced NSCLC met primary endpoint of PFS

Jiangsu Hengrui Pharmaceuticals announced that its HER3-directed ADC SHR-A2009 met the primary endpoint in the Phase 3 SHR-A2009-301 trial for patients with EGFR-mutant advanced or metastatic non-small cell lung cancer who had progressed after EGFR TKI therapy
In the interim analysis of the randomized, controlled, multicenter study, SHR-A2009 demonstrated a statistically significant improvement in progression-free survival compared with platinum-based doublet chemotherapy, reinforcing its potential as a new treatment option after EGFR TKI resistance develops
The Phase 3 trial enrolled 498 patients across 65 centers, randomizing participants to receive either SHR-A2009 monotherapy or platinum-based chemotherapy, with blinded independent central review assessed PFS serving as the primary endpoint
The results are particularly notable given the significant unmet need in EGFR-mutant NSCLC, where resistance to EGFR TKIs remains inevitable and HER3 expression is frequently upregulated following TKI treatment, contributing to disease progression and limited post-resistance treatment options
Hengrui stated that it plans to initiate pre-marketing communication with China’s Center for Drug Evaluation soon, while also advancing another Phase 3 trial evaluating SHR-A2009 as a first-line treatment for EGFR-mutant locally advanced or metastatic NSCLC