Shots:
- China’s NMPA has granted conditional approval to Hernexeos (zongertinib) for treating pts with inoperable, locally advanced or metastatic NSCLC harboring HER2 (ERBB2) mutations who have received prior systemic therapy
- Approval was based on P-Ib (Beamion LUNG-1) trial assessing Hernexeos alone, which showed improved ORR of 71% (N=75: 7% CR), mDoR of 14.1mos. & mPFS of 12.4mos., with 96% pts achieving disease control; results were shared at AACR’25 & published in The NEJM
- Hernexeos, a tyrosine kinase inhibitor (TKI) that selectively inhibits HER2, will be evaluated in P-III (Beamion LUNG-2) trial against SoC in 416 pts for inoperable, or metastatic non-squamous NSCLC harboring HER2 tyrosine kinase domain mutations
Ref: Boehringer Ingelheim| Image: Boehringer Ingelheim | Press Release
Related News:- The US FDA Grants Accelerated Approval to Boehringer Ingelheim’s Hernexeos for HER2-Mutant NSCLC
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