Zongertinib has been granted priority review from the US Food and Drug Administration (FDA) for the treatment of unresectable or metastatic NSCLC, following results from the Beamion LUNG-1 trial. The phase Ib trial reported a 71% objective response rate (ORR) in 75 patients with advanced HER2-mutated non-small cell lung cancer (NSCLC) who had received prior treatment. The primary outcomes measured were the maximum tolerated dose, ORR, and number of dose-limited toxicities.1
The first part of the study is designed to determine the highest dose of zongertinib that participants can tolerate.2 The determined amount is used in the second part to test its effectiveness in shrinking tumors.2 Participants were given zongertinib once or twice a day, and they received treatment as long as they benefit from, and can tolerate, treatment.1
The data showed a 6-month progression-free survival (PFS) rate of 69% and a duration of response of 73%. Additionally, the findings revealed that zongertinib had a low incidence of treatment discontinuations (3%) and dose reductions (5%) caused by treatment-related adverse events.
The priority review approval indicates the drug’s potential to provide significant advancements in the treatment, diagnosis, or prevention of serious diseases. Zongertinib, an orally administered treatment, is an irreversible TKI that selectively targets HER2. It’s designed to selectively spare EGFR mutations, which helps lower the risk of associated toxicities and adds to its favorable safety profile.
This latest FDA designation is one of several for zongertinib, which has already received Breakthrough Therapy designation and Fast Track designation from the FDA. Additionally, zongertinib has received global recognition from Japan’s Pharmaceuticals and Medical Devices Agency, which recently granted the drug Orphan Drug designation.
If approved, zongertinib would be the first orally administered treatment for NSCLC with HER2 mutations. Given the currently limited treatment options available, zongertinib has the potential to address an unmet need for this patient population.
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