Shots:
- The US FDA has granted accelerated approval to Hernexeos (zongertinib) for the 1L treatment of pts with advanced NSCLC harboring HER2 (ERBB2) tyrosine kinase domain activating mutations
- Approval was based on the data from a treatment-naïve cohort (N=72) of the P-Ib (Beamion LUNG-1) trial assessing Hernexeos as monotx., which showed improved ORR of 76% (11% CR & 65% PR) & a ≥6mos. DoR in 64% pts
- Hernexeos is further being evaluated in the P-III (Beamion LUNG-2) trial for 1L treatment of HER2 (ERBB2)-mutated advanced NSCLC, with enrolment currently ongoing
Ref: BI | Image: BI | Press Release
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