Oncology Brothers: Practice-Changing Cancer Discussions FDA Approval of Zongertinib for HER2 Mutated Non-Small Cell Lung Cancer (NSCLC) - Dr. Joshua Sabari
Aug 25, 2025
Dr. Joshua Sabari, a medical oncologist at NYU Langone Cancer Center, shares his expertise on the groundbreaking approval of Zongertinib for HER2-mutated non-small cell lung cancer. He discusses the prevalence of HER2 mutations, revealing key study findings with impressive response rates and progression-free survival data. The podcast dives into the management of side effects, particularly diarrhea, and compares Zongertinib with trastuzumab deruxtecan in treatment settings. Dr. Sabari also explores future directions for HER2-targeted therapies.
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Three Distinct HER2 Alterations
- HER2 alterations in NSCLC are three distinct entities: mutation, overexpression, and amplification.
- Match the alteration type to the appropriate test and therapy to avoid confusion in care.
Trial Focused On HER2 TKD Mutations
- The BMEI Lung‑1 (dose escalation + expansion) targeted HER2 TKD mutations specifically and excluded EGFR inhibition.
- This focused design produced high activity in the tyrosine kinase domain cohort, distinguishing it from broader inhibitors.
High Response Rates And Durability
- Zongertinib produced a 71% overall response rate and median PFS of 12.4 months in pretreated patients with HER2 TKD mutations.
- Responses included complete responses (~5–6%) and durable responses with median DOR ~14.1 months.