Among previously treated patients with human epidermal growth factor receptor 2 (HER2, ERBB2)–mutant advanced non-small cell lung cancer (NSCLC), zongertinib has received priority review from the Food and Drug Administration (FDA), according to a news release from the drug’s manufacturer, Boehringer Ingelheim.
According to the FDA’s website, a priority review designation prioritizes the evaluation of certain drug applications. After approval, these drugs would significantly improve the safety or effectiveness of treatment, diagnosis or prevention of serious conditions compared with standard applications.
“We believe zongertinib has the potential to transform the care of previously treated patients with HER2 (ERBB2)-mutant advanced non-small cell lung cancer and are hopeful about the continued research in other tumor types and lines of therapy,” Shashank Deshpande, Member of the Board of Managing Directors and Head of Human Pharma at Boehringer Ingelheim, said in the news release. “Priority Review illustrates the urgent need in this patient population and the possibility for zongertinib to be a groundbreaking innovation for patients with limited treatment options.”
If approved, zongertinib would be the first orally administered and targeted therapy treatment for patients with HER2 NSCLC.
Glossary:
Human epidermal growth factor receptor 2 (HER2): a protein on the surface of some cancer cells that, when overexpressed, promotes tumor growth.
Metastases: spreading of cancer
Tyrosine kinase inhibitor: a drug that blocks the action of enzymes involved in cancer cell growth.
Objective response rate: the percentage of patients whose tumors shrink or disappear after treatment.
Progression-free survival: the length of time a patient lives without their disease worsening.
Duration of response: the period during which a patient's tumor remains reduced or absent following treatment.
Positive results from the phase 1b BEAMION LUNG-1 cohort 1 trial, which showed a 71% objective response rate in 75 previously treated patients with advanced NSCLC, support the application for this investigational treatment. In addition, six-month progression-free survival and duration of response rates were 69% and 73%, respectively, in patients with HER2 tyrosine kinase domain mutations.
Regarding side effects, zongertinib demonstrated a favorable safety profile, with low rates of dose reductions (5%) and treatment discontinuations (3%). Most treatment-related side effects (TRAEs) were mild, with diarrhea (51%) and rash (27%) being the most common. No new safety signals were observed. Grade 3 (severe) or worse TRAEs occurred in one patient, and no treatment-related interstitial lung disease cases were reported.
“Personalized medicine has revolutionized cancer treatment,” said GO2 for Lung Cancer’s Chief Scientific Officer, Courtney Granville, in the news release. “Early screening and biomarker testing for mutations provide critical information to guide targeted therapies in personalized medicine. This filing acceptance represents a significant step toward offering another option for individuals with a HER2 (ERBB2) diagnosis, bringing hope and direction to cancer patients.”
Zongertinib (BI 1810631) is an investigational irreversible tyrosine kinase inhibitor designed to selectively block HER2 (ERBB2) while minimizing EGFR-related toxicities, according to the release. This oral therapy is being evaluated for HER2-mutant advanced NSCLC, with ongoing studies in solid tumors with HER2 alterations.
The BEAMION LUNG-1 trial is an open-label phase 1 study evaluating zongertinib monotherapy in patients with unresectable or metastatic solid tumors with HER2 alterations. It includes dose escalation, confirmation and expansion phases. The next phase 3 BEAMION LUNG-2 trial is an open-label, randomized study that will compare zongertinib with standard of care in patients with unresectable or metastatic NSCLC with HER2 tyrosine kinase domain mutations.
NSCLC is the most common lung cancer subtype, often diagnosed at stage 3 or 4 due to a lack of symptoms and frequent misdiagnoses, as per the release. Fewer than 30% of patients with HER2-mutant advanced NSCLC survive beyond five years. The disease significantly impacts patients’ physical, psychological and emotional well-being, highlighting the need for additional treatment options. HER2 mutations occur in approximately 2% to 4% of NSCLC cases and are linked to poor prognosis and a higher risk of brain metastases. These mutations can drive tumor growth by promoting uncontrolled cell production, inhibiting cell death and accelerating disease progression.
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