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HER3-DXd
HER3-DXd is a HER3-targeting antibody-drug conjugate Biologic drug developed by Merck Sharp & Dohme LLC. It is currently in Phase 2 development for Breast cancer, Gastric cancer. Also known as: patritumab deruxtecan, U3-1402, MK-1022, patritumab deruxtecan, MK-1022, U3-1402.
HER3-DXd is a HER3-targeting antibody-drug conjugate.
HER3-DXd is an antibody used to treat various types of cancer, including gastrointestinal cancer, malignant neoplasm, advanced solid tumor, melanoma, and head and neck cancer. It is a form of patritumab deruxtecan, a treatment being studied in clinical trials.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 2 attrition
-2.0pp
Oncology drugs have higher Phase 2-to-Phase 3 attrition than average — many fail to show OS benefit in larger studies. -
Big-pharma sponsor
+3.0pp
Merck Sharp & Dohme LLC is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | HER3-DXd |
|---|---|
| Also known as | patritumab deruxtecan, U3-1402, MK-1022, patritumab deruxtecan, MK-1022, U3-1402, Patritumab deruxtecan |
| Sponsor | Merck Sharp & Dohme LLC |
| Drug class | HER3-targeting antibody-drug conjugate |
| Target | HER3 |
| Modality | Biologic |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Mechanism of action
HER3-DXd works by binding to the HER3 receptor and delivering a cytotoxic payload to cancer cells that overexpress HER3.
Approved indications
- Breast cancer
- Gastric cancer
Common side effects
- Nausea
- Fatigue
- Diarrhea
Key clinical trials
- A Study of Patritumab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors (MK-9999-01C/LIGHTBEAM-U01) (PHASE1, PHASE2)
- A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016) (PHASE3)
- Substudy 06C: A Study of Investigational Agents With Pembrolizumab (MK-3475) and Chemotherapy in Participants With First-Line Locally Advanced Unresectable/Metastatic Gastroesophageal Adenocarcinoma (MK-3475-06C/KEYMAKER-U06) (PHASE1, PHASE2)
- Substudy 06D: Combination Therapies in Second Line (2L) Gastroesophageal Adenocarcinoma (MK-3475-06D/Keymaker-U06) (PHASE1, PHASE2)
- KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A) (PHASE1, PHASE2)
- A Clinical Study of MK-1084 With Other Treatments for Non-small Cell Lung Cancer (MK-3475-01F) (PHASE1, PHASE2)
- Study of Patritumab Deruxtecan in Participants With Gastrointestinal Cancers (MK-1022-011) (HERTHENA-PanTumor02) (PHASE1, PHASE2)
- Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03) (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- HER3-DXd CI brief — competitive landscape report
- HER3-DXd updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI
Frequently asked questions about HER3-DXd
What is HER3-DXd?
How does HER3-DXd work?
What is HER3-DXd used for?
Who makes HER3-DXd?
Is HER3-DXd also known as anything else?
What drug class is HER3-DXd in?
What development phase is HER3-DXd in?
What are the side effects of HER3-DXd?
What does HER3-DXd target?
Related
- Drug class: All HER3-targeting antibody-drug conjugate drugs
- Target: All drugs targeting HER3
- Manufacturer: Merck Sharp & Dohme LLC — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Breast cancer
- Indication: Drugs for Gastric cancer
- Also known as: patritumab deruxtecan, U3-1402, MK-1022, patritumab deruxtecan, MK-1022, U3-1402, Patritumab deruxtecan
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing