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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.
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.
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.
Shares Non-small-cell lung cancer and the tags biomarker, surface-antigen, no-threshold.
Shares Non-small-cell lung cancer and the tags biomarker, surface-antigen, no-threshold.
Shares the tags biomarker, surface-antigen, no-threshold.
Shares the tags biomarker, surface-antigen, no-threshold.
Shares the tags biomarker, surface-antigen, no-threshold.
Shares the tags biomarker, surface-antigen, no-threshold.
Shares the tags biomarker, surface-antigen, no-threshold.
Shares the tags biomarker, surface-antigen, no-threshold.