For the first time, FDA has given approval of an oral treatment of patients with unresectable or metastatic non-squamous non-small cell lung cancer whose tumors have human epidermal growth factor receptor 2 (HER2/ERBB2) tyrosine kinase domain activating mutations. Hernexeos (zongertinib) is a new 60mg tablet for adults with type of advanced lung cancer called non-small cell lung cancer having HER2 gene mutations causing cancer to grow and spread faster. The recommended dosage depends on body weight and is taken once with or without food until disease progression. The dosage modifications may be required for certain adverse reactions.
This approval was based on single-arm, open-label, phase 1b Beamion Lung-1 trial. Patients with stable brain metastases were enrolled into the study. The participants received oral zongertinib 120mg once daily. Findings showed that Objective Response Rate was 75%, with 6% of participants achieving complete response and 69% achieving partial response. Also, 58% of patients had a response lasting for at least half a year. Zongertinib was also evaluated in patients with unresectable or metastatic HER2 tyrosine kinase domain mutations positive NSCLC who had received prior treatment with platinum-based chemotherapy.
In this study, the common side effects reported were diarrhea, rash, fatigue, nausea and hepatoxicity. Dr John Heymach, MD, PhD, chair of Thoracic/Head and Neck Medical Oncology at The University of Texas MD Anderson Cancer Center said, “With the approval of zongertinib, we have an effective, targeted, orally administered treatment option for patients with HER2 (ERBB2)-mutant non-small cell lung cancer in the US that not only elicits a durable response but, importantly, has a manageable safety profile.” Its continued approval is contingent upon verification and description of Clinical benefit in a confirmatory trial.
The information shared in this blog is for educational purposes only and is not a substitute for medical advice.
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