Shots:
- The NMPA has granted conditional approval to Hernexeos (zongertinib) for initial treatment of adults with unresectable, locally advanced, or metastatic NSCLC harboring HER2 (ERBB2) tyrosine kinase domain-activating mutations
- Approval was based on the data from a treatment-naïve cohort (N=74) of P-Ib (Beamion LUNG-1) trial assessing Hernexeos as monotx., which showed improved ORR of 75.7% (10.8% CR & 64.9% PR) & mDoR of 15.2mos.; data was published in The NEJM
- Hernexeos is further being evaluated in the P-III (Beamion LUNG-2) trial for 1L treatment of HER2 (ERBB2)-mutated advanced NSCLC & P-III (Beamion LUNG-3) as an adjuvant monotx. in pts with early-stage, resectable NSCLC (Stage II-IIIB) with HER2 (ERBB2)-mutations
Ref: Globenewswire | Image: BI | Press Release
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