Originally published by our sister publication Clinical Oncology News
By Clinical Oncology News Staff
The FDA granted accelerated approval to zongertinib (Hernexeos, Boehringer Ingelheim), a kinase inhibitor, for adults with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy.
FDA also approved the Oncomine Dx Target Test (Life Technologies) as a companion diagnostic device to aid in detecting HER2 (ERBB2) TKD activating mutations in patients with non-squamous NSCLC who may be eligible for treatment with zongertinib.
Efficacy was evaluated in patients with unresectable or metastatic, non-squamous NSCLC with HER2 (ERBB2) TKD mutations who had received prior systemic therapy and received zongertinib in Beamion LUNG-1 (ClinicalTrials.gov Identifier: NCT04886804), an open-label, multi-center, multi-cohort trial. The major efficacy outcome measures were objective response rate (ORR) and duration of response (DOR) determined by blinded independent central review per RECIST v1.1.
Among 71 patients who received prior platinum-based chemotherapy but had not been previously treated with a HER2-targeted tyrosine kinase inhibitor or antibody-drug conjugate (ADC), ORR was 75% (95% CI, 63%-83%), with 58% having a DOR of at least six months. Among 34 patients previously treated with platinum-based chemotherapy and a HER2-targeted ADC, ORR was 44% (95% CI, 29%-61%), with 27% having a DOR of at least 6 months.
The prescribing information includes warnings and precautions for hepatotoxicity, left ventricular dysfunction, interstitial lung disease/pneumonitis, and embryo-fetal toxicity.
Full prescribing information for zongertinib will be posted on Drugs@FDA.
Based on a press release from the FDA.
