Enhertu Gains EU Tumour‑Agnostic Approval For HER2‑Positive Metastatic Solid Tumours | iPharmaCenter
- Badari Andukuri
- 14 minutes ago
- 2 min read
The European Commission (EC) has granted tumor-agnostic approval for Enhertu (trastuzumab deruxtecan) to treat adult patients presenting with unresectable or metastatic HER2-positive solid tumors.
Because the indication is tumor-agnostic, the authorization applies to any solid malignancy meeting the HER2 IHC 3+ criteria, moving beyond organ-specific boundaries like breast or lung cancers.
This European regulatory milestone mirrors recent approvals in other global markets. The decision rests on pooled efficacy data from three distinct Phase II clinical trials evaluating the antibody-drug conjugate (ADC) across diverse oncological indications.
DESTINY-PanTumor02: Efficacy Across Diverse Solid Tumors
The DESTINY-PanTumor02 trial evaluated pretreated patients across a broad spectrum of HER2-expressing solid malignancies, including pancreatic, ovarian, bladder, cervical, endometrial, and biliary tract cancers. Within the cohort explicitly identified with centrally or locally verified HER2 IHC 3+ expression, Enhertu demonstrated a confirmed objective response rate (cORR) of 52.3%. Furthermore, these patients achieved a median duration of response (mDoR) of 21.1 months.
DESTINY-Lung01: Focus on HER2 IHC 3+ NSCLC
The second pivotal trial, DESTINY-Lung01, assessed a specific cohort of patients with heavily pretreated, HER2-positive non-small cell lung cancer (NSCLC) confirmed via IHC 3+ testing. In this critical patient subset, Enhertu treatment yielded a cORR of 52.9%, alongside an mDoR of 6.9 months.
DESTINY-CRC02: Advanced Colorectal Cancer Outcomes
Data for the colorectal cancer segment of the regulatory submission came from the DESTINY-CRC02 trial. This study enrolled patients with centrally validated HER2 IHC 3+ metastatic colorectal tumors who progressed on previous lines of therapy. In this population, Enhertu achieved a cORR of 46.9% with an mDoR of 5.5 months.
Mechanism of Action
HER2 is a member of the ErbB receptor tyrosine kinase family, vital for modulating cellular growth and survival pathways in epithelial tissues. Overexpression of HER2 leads to dysregulated intracellular signaling, which promotes oncogenesis. While this overexpression occurs across various solid tumors, its prevalence varies widely by tissue type. Enhertu leverages this surface receptor as a target, utilizing a selective anti-HER2 antibody to deliver a potent cytotoxic payload directly into the malignant cells.