Shots:
- The US FDA has granted accelerated approval to Hernexeos (zongertinib) for the treatment of pts with inoperable 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 as monotx., which showed improved ORR of 75% (N=71: 6% CR & 69% PR) & a ≥6mos. DoR in 58% pts (n=53); results were shared at AACR 2025 & published in The NEJM
- Hernexeos, a tyrosine kinase inhibitor (TKI) that selectively inhibits HER2, is being evaluated in multiple trials, across advanced solid tumors with HER2 alterations
Ref: Boehringer Ingelheim| Image: Boehringer Ingelheim | Press Release
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