Boehringer’s lung cancer medicine gets FDA approval

FDA grants accelerated approval to zongertinib for HER2 TKD-Mutated Non-Squamous NSCLC

The FDA has granted accelerated approval to zongertinib (Hernexeos, Boehringer Ingelheim Pharmaceuticals) for unresectable or metastatic nonsquamous non–small cell lung cancer (NSCLC) with HER2 (ERBB2) tyrosine kinase domain (TKD)–activating mutations.

The FDA also approved the Oncomine Dx Target Test (Life Technologies Corporation) as a companion diagnostic to detect HER2 (ERBB2) TKD activating mutations in patients with non-squamous NSCLC eligible for treatment with zongertinib.

Efficacy was evaluated in Beamion LUNG-1 (NCT04886804), an open-label, multi-center trial in patients with unresectable or metastatic non-squamous NSCLC with HER2 TKD mutations who had received prior systemic therapy. The primary endpoints were objective response rate (ORR) and duration of response (DOR), determined by blinded independent central review.

Among 71 patients who received prior platinum-based chemotherapy but no 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 who received prior platinum-based chemotherapy and a HER2-targeted ADC, ORR was 44% (95% CI: 29, 61), with 27% having a DOR of at least six months.

Prescribing information includes warnings and precautions for hepatotoxicity, left ventricular dysfunction, interstitial lung disease/pneumonitis, and embryo-fetal toxicity.

The recommended dose is based on body weight: 120 mg orally once daily for patients under 90 kg, and 180 mg orally once daily for patients 90 kg or above. Zongertinib can be taken with or without food and continued until disease progression or unacceptable toxicity.

The review used the Real-Time Oncology Review (RTOR) program, enabling data submission prior to the full application, and the Assessment Aid to facilitate FDA evaluation. The application received priority review, breakthrough therapy designation, and fast track designation.