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A HER3-directed ADC with Enhertu's payload, active in lung and all subtypes of breast cancer, but with a bumpy regulatory road.
HERTHENA-Lung01 in EGFR-mutant NSCLC after TKI (ORR ~30%) led to a BLA that received a complete response letter in 2024 over manufacturing; HERTHENA-Lung02 phase 3 was positive for PFS but not OS. In breast cancer, HERTHENA-BC dose-expansion data at ESMO Breast 2026 showed activity across HR+/HER2-, HER2+, and TNBC. Daiichi Sankyo and Merck partnership.
Ball-and-stick model from PubChem 2D record (no 3D conformer available). PubChem record
Anti-HER3 IgG1 with DXd. Connects to HER3.
1.Antibody binds HER3 on the tumour cell surface
Source: clinicaltrials.gov/study/NCT04619004. Doses are for orientation; the current label governs.
| Date | Deal | Type | Upfront | Total | Source |
|---|---|---|---|---|---|
| 2023-10-20 | Daiichi Sankyo to Merck & Co. (MSD) Patritumab deruxtecan (HER3), ifinatamab deruxtecan (B7-H3) and raludotatug deruxtecan (CDH6) | Co-development | $4.0bn (plus $1.5bn in continuation payments over 24 months) | up to $22bn | source |
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Breakthrough Therapy designation, EGFR-mutant NSCLC after TKI and platinum source
BLA submitted (HERTHENA-Lung01) source
Complete response letter citing third-party manufacturing inspection source
BLA withdrawn after HERTHENA-Lung02 met PFS but not OS source
| Adverse event |
|---|
| Neutropenia |
| Thrombocytopenia |
| Nausea |
| Fatigue |
| ILD/pneumonitis |
Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Investigational; BLA withdrawn May 2025 after HERTHENA-Lung02 OS result | not disclosed | - |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
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Query for this drug: (TITLE:"Patritumab deruxtecan" OR ABSTRACT:"Patritumab deruxtecan" OR TITLE:"HER3-DXd" OR ABSTRACT:"HER3-DXd" OR TITLE:"U3-1402" OR ABSTRACT:"U3-1402") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Patritumab deruxtecan, not a curated reading list.
Shares Tetrapeptide GGFG (maleimide-GGFG-aminomethyl), DXd, Topoisomerase-I inhibitor payloads, Daiichi Sankyo.
Shares EGFR TKI → ADC on progression, Benjamin Besse, Tetrapeptide GGFG (maleimide-GGFG-aminomethyl), DXd.
Shares Benjamin Besse, Daiichi Sankyo, Antibody-drug conjugate (ADC), Lung cancer (all types).
Shares Tetrapeptide GGFG (maleimide-GGFG-aminomethyl), DXd, Topoisomerase-I inhibitor payloads, Daiichi Sankyo.
Shares Daiichi Sankyo, Metastatic triple-negative breast cancer, Antibody-drug conjugate (ADC), Triple-negative breast cancer (TNBC).
Shares EGFR TKI → ADC on progression, Topoisomerase-I inhibitor payloads, HER3, Metastatic triple-negative breast cancer.
Shares Metastatic triple-negative breast cancer, Merck & Co. (MSD), Antibody-drug conjugate (ADC), Triple-negative breast cancer (TNBC).
Shares Daiichi Sankyo, EGFR-mutated non-small-cell lung cancer, Antibody-drug conjugate (ADC), Non-small-cell lung cancer.