HER3 expression
HER3 is a signalling partner of EGFR and HER2 present on most lung and breast cancers. Patritumab deruxtecan was studied in EGFR-mutant lung cancer without a HER3 threshold, and no approval exists.
Overview
Patritumab deruxtecan showed activity in EGFR-mutant NSCLC after osimertinib (HERTHENA-Lung01, HERTHENA-Lung02, NCT05338970) irrespective of HER3 membrane H-score; the US application received a complete response letter in 2024 on manufacturing grounds and no approval has followed. NRG1 fusions, which signal through HER3, are the selection marker for zenocutuzumab, a separate readout.
- Target · the protein and the cell it sits on
- Drug · antibody, small molecule, cell or radioligand
- Effect · signal, damage or kill
In plain words · HER3 is a cousin of HER2 that cancers use as an escape route when HER2 or EGFR are blocked.
There is no approved HER3-directed drug and no HER3 test you would routinely have. Patritumab deruxtecan is available only in trials, which enrol on the EGFR mutation rather than on HER3 staining.
Written only from the label or guideline text cited on this page. Not medical advice; your own report and the reading your team gives it come first.
The label names the antigen in the drug's description but does not require it to be measured before treatment; no approval threshold exists for this readout.
“HERTHENA-Lung02: patritumab deruxtecan versus platinum-based chemotherapy in EGFR-mutated NSCLC after EGFR TKI”
ClinicalTrials.gov NCT05338970 (HERTHENA-Lung02)No approval uses this readout as a threshold. It is defined by HERTHENA-Lung02 (NCT05338970).
Matched on the name and aliases of the readout in the title, setting and summary of each trial; a match is a mention, not proof the readout was an entry criterion.
- NCT06382142 · 2026BL-B01D1-307
- NCT05338970 · 2025HERTHENA-Lung02
- NCT06956690A Phase 1/2 Clinical Trial to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HMBD-501 in Patients With HER3-Expressing
- NCT05910827A Phase Ib/II Study of an Anti-HER3 Antibody, HMBD-001, With Cetuximab +/- Docetaxel in Advanced Squamous Cell Cancers
- NCT06172478A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors
- NCT02912949A Study of Zenocutuzumab (MCLA-128) in Patients With Solid Tumors Harboring an NRG1 Fusion (eNRGy)
- NCT06194656Clinical Trial of SIBP-03 in Patients With Head and Neck Squamous Cell Carcinoma
- NCT06926868IZABRIGHT-Breast01
- NCT06445972Substudy 06D: Combination Therapies in Second Line (2L) Gastroesophageal Adenocarcinoma (MK-3475-06D/Keymaker-U06)
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