Summary of clinical efficacy and patient feedback of zongertinib-Hernexeos

Zongertinib (trade name: Hernexeos) is a tyrosine-based drug that targets HER2 (ERBB2) Oral small molecule targeted drugs with mutations in the kinase domain (TKD) are mainly used to treat patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC). In an open-label, multicenter, multi-cohort clinical trial of Beamion LUNG-1 (NCT04886804), investigators evaluated the efficacy of Hernexeos in patients who had previously received systemic therapy. The main efficacy indicators are the objective response rate (ORR) and duration of response (DOR) determined by the blind independent central review (BICR), which provide reliable basis for the clinical performance of the drug in real patient groups.

In the trial, 71patients who had previously received platinum-based chemotherapy but had not received HER2 targeted tyrosine kinase inhibitors or antibody-drug conjugates (ADCs) treated patients, Hernexeos showed significant efficacy: ORR reached 75% (95% CI: 63–83), and 58% of patients had a duration of response (DOR) ≥6 months. This suggests that Hernexeos can achieve a high rate of tumor shrinkage and durable response in patients who have not received specific HER2-targeted therapy, providing an effective treatment option for this refractory patient population.

For 34 patients who had previously received platinum-based chemotherapy and HER2targeted ADC treatment, Hernexeos still showed good efficacy: ORRis44% (95% CI: 29–61), of which 27% of patients had DOR ≥6 months. Although the response rate in this population is relatively low, it still shows that Hernexeos still has certain anti-tumor activity in patients who have received multiple lines of treatment in the past, providing valuable clinical treatment opportunities. Patient feedback shows that the drug is convenient to take orally and can be used with meals or on an empty stomach. Most adverse reactions during treatment can be alleviated through symptomatic treatment or adjustment of medication strategies.

In terms of safety, the prescription information of Hernexeos reminds people to pay attention to potential risks such as hepatotoxicity, left ventricular dysfunction, interstitial lung disease/pneumonia, and embryonic-fetal toxicity. During use, patients should undergo regular liver function, heart function and imaging examinations, and strictly follow the doctor's guidance for individualized monitoring and dose adjustment. At the same time, women during pregnancy or childbearing age need to take effective contraceptive measures to avoid risks to the embryo-fetus. Overall, the Beamion LUNG-1 trial results show that Hernexeos has significant efficacy and controllable tolerability in HER2mutated NSCLC patients, providing a reliable basis for clinical treatment.

Reference link:https://www.drugs.com