Boehringer Ingelheim has received accelerated approval from the FDA for Hernexeos (zongertinib), the first orally-administered targeted therapy for HER2 (ERBB2)-mutant advanced non-small cell lung cancer (NSCLC).
Zongertinib is a tyrosine kinase inhibitor that selectively inhibits HER2 (ERBB2). Approximately 2% to 4% of NSCLC cases have HER2 mutations. These cases often have a poor prognosis and a higher incidence brain metastases.
The accelerated approval is based on data from the phase 1b Beamion-LUNG 1 trial, demonstrating an objective response rate of 75% (N=71). Hernexeos tablets produced a complete response in 6% patients and a partial response in 69% patients as well a duration response of ≥6 months in 58% patients. The oral drug also demonstrated a manageable safety profile, with a 2.9% discontinuation rate.
The FDA also approved the Oncomine Dx Target Test from Life Technologies as a companion diagnostic device to aid in detecting HER2 TKD activating mutations in patients with non-squamous NSCLC who may be eligible for treatment with Hernexeos.