Drugs / Patritumab deruxtecan
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn non-small cell lung carcinoma 2 milestones | |||||
| Withdrawn | US (FDA) | — | non-small cell lung carcinoma | 2025-05-29 | “The decision to withdraw the BLA is based on topline overall survival (OS) results from the confirmatory HERTHENA-Lung02 Phase 3 trial” merck.com ↗ |
| Rejected (CRL) | US (FDA) | — | non-small cell lung carcinoma | 2024-06-26 | “Patritumab Deruxtecan Biologics License Application Submission Received Complete Response Letter From FDA Due to Inspection Findings at Third-Party Manufacturer” merck.com ↗ “The decision is unrelated to the Complete Response Letter that was received in June 2024” merck.com ↗ |
| Filed lung cancer 1 milestone | |||||
| Filed | US (FDA) | — | lung cancer | 2023-12-22 | “the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to the Biologics License Application (BLA) for patritumab deruxtecan” merck.com ↗ |
Trials 22
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT04610528 | Dec 2020 → Jan 2022 | breast cancer | SOLTI Breast Cancer Research Group | Unknown | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT03260491 | Oct 2017 → Mar 2026 overdue | non-small cell lung carcinoma | Daiichi Sankyo | Active not recruiting | No outcome recorded |
| Phase 1/28 trials | ||||||
| Phase 1/2 | NCT07701941 | Sep 2026 → Jan 2031 expected | hormone receptor-positive breast cancer | Daiichi Sankyo | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07286149 | Apr 2026 → Aug 2029 expected | lung cancer | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06941272 | May 2025 → Dec 2030 expected | cancer | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06686394 | Feb 2025 → Apr 2030 expected | breast cancer | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06596694 | Nov 2024 → Dec 2028 expected | digestive system cancer | Merck Sharp & Dohme LLC | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT06469944 | Sep 2024 → Sep 2029 expected | esophageal cancer, gastroesophageal adenocarcinoma, gastroesophageal junction adenocarcinoma | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06298084 | Mar 2024 → Sep 2027 expected | HER2 positive breast carcinoma | Gustave Roussy, Cancer Campus, Grand Paris | Recruiting | No outcome recorded |
| Phase 1/2 | NCT02980341 | Nov 2016 → Aug 2021 | breast cancer | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 210 trials · 2 met primary | ||||||
| Phase 2 | NCT05620914 | Jul 2025 → Apr 2026 | metastatic malignant neoplasm in the brain | Mustafa Khasraw, MBChB, MD, FRCP, FRACP | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT06797635 | Mar 2025 → Dec 2029 expected | breast cancer | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 2 | NCT06222489 | Mar 2025 → May 2027 expected | non-small cell squamous lung carcinoma | The Netherlands Cancer Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT06383884 | Aug 2024 → Apr 2027 expected | — | Samsung Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05865990 | Nov 2023 → Nov 2024 | breast cancer, non-small cell squamous lung carcinoma | MedSIR | Completed | Met primary |
| Phase 2 | NCT05569811 | Nov 2022 → Mar 2025 overdue | breast cancer | SOLTI Breast Cancer Research Group | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04965766 | May 2021 → Apr 2027 expected | breast cancer | Gustave Roussy, Cancer Campus, Grand Paris | Recruiting | Met primary |
| Phase 2 | NCT04699630 | May 2021 → Apr 2025 | breast cancer, metastatic malignant neoplasm | SCRI Development Innovations, LLC | Completed | No outcome recorded |
| Phase 2 | NCT04619004 | Feb 2021 → Nov 2022 overdue | non-small cell lung carcinoma | Daiichi Sankyo | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04479436 | Sep 2020 → Feb 2022 | colorectal cancer | Daiichi Sankyo | Terminated | No outcome recorded |
| Phase 32 trials · 1 met primary | ||||||
| Phase 3 | NCT07060807 | Jul 2025 → Jul 2033 expected | breast neoplasm | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT05338970 | Jul 2022 → May 2024 overdue | non-small cell lung carcinoma | Daiichi Sankyo | Active not recruiting | Met primary |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2025-05-29 | Merck Sharp & Dohme LLC | Regulatory Patritumab Deruxtecan Biologics License Application for Patients With Previously Treated Locally Advanced or Metastatic EGFR-Mutated Non-Small Cell Lung Cancer Voluntarily Withdrawn merck.com ↗
The Biologics License Application (BLA) seeking accelerated approval in the U.S. for Daiichi Sankyo (TSE: 4568) and Merck’s (NYSE: MRK), known as MSD outside of the United States and Canada, patritumab deruxtecan (HER3-DXd), based on the HERTHENA-Lung01 Phase 2 trial for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) previously treated with two or more systemic therapies, has been voluntarily withdrawn. |
| 2024-09-17 | Merck Sharp & Dohme LLC | Results Patritumab Deruxtecan Demonstrated Statistically Significant Improvement in Progression-Free Survival Versus Doublet Chemotherapy in Patients with Locally Advanced or Metastatic EGFR-Mutated Non-Small Cell Lung Cancer in HERTHENA-Lung02 Phase 3 Trial merck.com ↗
Daiichi Sankyo and Merck’s patritumab deruxtecan demonstrates a statistically significant progression-free survival improvement in this EGFR-mutated non-small cell lung cancer population with high unmet need following prior EGFR TKI treatment |
| 2024-06-26 | Merck Sharp & Dohme LLC | Regulatory Patritumab Deruxtecan BLA Submission Receives Complete Response Letter from FDA Due to Inspection Findings at Third-Party Manufacturer merck.com ↗
The CRL results from findings pertaining to an inspection of a third-party manufacturing facility. |
| 2023-12-22 | Merck Sharp & Dohme LLC | Regulatory Patritumab Deruxtecan Granted Priority Review in the U.S. for Certain Patients with Previously Treated Locally Advanced or Metastatic EGFR-Mutated Non-Small Cell Lung Cancer merck.com ↗
Daiichi Sankyo (TSE: 4568) and Merck, known as MSD outside of the United States and Canada, (NYSE: MEK) announced today that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to the Biologics License Application (BLA) for patritumab deruxtecan (HER3-DXd) for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) previously treated with two or more systemic therapies. |
| 2021-01-29 | Daiichi Sankyo | Results New Biomarker Analyses from Patritumab Deruxtecan Phase 1 Study in Patients with EGFR-Mutated NSCLC Presented at WCLC 2020 daiichisankyo.com ↗
New Biomarker Analyses from Patritumab Deruxtecan Phase 1 Study in Patients with EGFR-Mutated NSCLC Presented at WCLC 2020 |
| 2020-09-18 | Daiichi Sankyo | Results Daiichi Sankyo Announces Late-Breaking Phase 1 Dose Expansion Data for Patritumab Deruxtecan in Patients with EGFR-Mutated NSCLC at ESMO 2020 daiichisankyo.com ↗
HER3 directed ADC demonstrates clinical activity in patients with EGFR-mutated metastatic or unresectable NSCLC previously treated with a tyrosine kinase inhibitor (TKI) and platinum-based chemotherapy in first presentation of dose expansion data for patritumab deruxtecan |
| 2019-09-10 | Daiichi Sankyo | Results Updated Phase 1 Data for Daiichi Sankyo’s U3-1402 in Patients with EGFR Mutated NSCLC Presented at 2019 World Conference on Lung Cancer daiichisankyo.com ↗
Updated efficacy results for 26 patients who received U3-1402 in one of four dose cohorts, and had baseline and at least one post-baseline tumor assessment, showed six confirmed partial responses across three dose levels. |
| 2019-06-03 | Daiichi Sankyo | Results Daiichi Sankyo Presents Preliminary Phase 1 Data for HER3 Targeting ADC U3-1402 in Patients with EGFR Mutated Non-Small Cell Lung Cancer at 2019 ASCO Annual Meeting daiichisankyo.com ↗ |
| 2018-12-06 | Daiichi Sankyo | Results Daiichi Sankyo Presents Updated Phase 1 Data for U3-1402 in Patients with HER3-Expressing Metastatic Breast Cancer at 2018 San Antonio Breast Cancer Symposium (SABCS) daiichisankyo.com ↗
Preliminary efficacy data demonstrated a 42.9 percent confirmed overall response rate and a 90.5 percent disease control rate at a median follow-up time of 10.5 months |
| 2018-06-01 | Daiichi Sankyo | Results Daiichi Sankyo Presents Preliminary Phase 1 Data for Antibody Drug Conjugate U3-1402 in Patients with HER3-Expressing Breast Cancer at 2018 American Society of Clinical Oncology (ASCO) Annual Meeting daiichisankyo.com ↗
Preliminary efficacy data demonstrated a 47 percent confirmed overall response rate and a 94 percent disease control rate with U3-1402 |
All press releases naming this drug 17 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 26 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Patritumab deruxtecan | “Patritumab deruxtecan (HER3-DXd; MK-1022) is an investigational HER3-directed antibody-drug conjugate composed of a human immunoglobulin G1 monoclonal antibody to HER3...” PMID 40554742 ↗ Jun 202519“a phase 2 study evaluating efficacy, safety and biomarkers of response and resistance to patritumab deruxtecan (HER3-DXd), in patients with HR+HER2- metastatic breast cancer” PMID 40908353 ↗ Sep 2025 |
| Known as | HER3-DXd | “Patritumab deruxtecan (HER3-DXd; MK-1022) is an investigational HER3-directed antibody-drug conjugate composed of a human immunoglobulin G1 monoclonal antibody to HER3...” PMID 40554742 ↗ Jun 20255“This peri-operative window of opportunity study in patients with brain metastases will provide a single dose of the antibody-drug conjugate (ADC) patritumab deruxtecan...” NCT05620914 ↗ “A Phase 2 Trial of neoadjuVAnt muLti-agENT Chemotherapy or Patritumab Deruxtecan (HER3-DXd; U3-1402) With or Without endocrINE Therapy for High-risk HR+/HER2- Breast Cancer -...” NCT05569811 ↗ “Patritumab deruxtecan (HER3-DXd) is an investigational HER3-targeted antibody-drug conjugate” PMID 37801674 ↗ Oct 2023 “the HER3 directed antibody drug conjugate patritumab deruxtecan (HER3-DXd; U3-1402)” PMID 33968735 ↗ Apr 2021 “patritumab deruxtecan (U3-1402; HER3-DXd) has been shown” NCT06222489 ↗ |
| Known as | MK-1022 | “Patritumab deruxtecan (HER3-DXd; MK-1022) is an investigational HER3-directed antibody-drug conjugate composed of a human immunoglobulin G1 monoclonal antibody to HER3...” PMID 40554742 ↗ Jun 2025 |
| Known as | U3-1402 | “This peri-operative window of opportunity study in patients with brain metastases will provide a single dose of the antibody-drug conjugate (ADC) patritumab deruxtecan...” NCT05620914 ↗7“A Phase 2 Trial of neoadjuVAnt muLti-agENT Chemotherapy or Patritumab Deruxtecan (HER3-DXd; U3-1402) With or Without endocrINE Therapy for High-risk HR+/HER2- Breast Cancer -...” NCT05569811 ↗ “Patritumab Deruxtecan (U3-1402) in Unresectable Locally Advanced or Metastatic Breast Cancer” NCT04965766 ↗ “the HER3 directed antibody drug conjugate patritumab deruxtecan (HER3-DXd; U3-1402)” PMID 33968735 ↗ Apr 2021 “patritumab deruxtecan (U3-1402; HER3-DXd) has been shown” NCT06222489 ↗ “U3-1402” NCT04479436 ↗ |
| Known as | U3-1402A | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594611 ↗ |
| Action | Deplete | “delivers treatment to destroy those cells” NCT06941272 ↗ |
| Action | Inhibit | “DNA topoisomerase I inhibitor” CHEMBL4594611 ↗ |
| Modality | Monoclonal antibody | “a recombinant fully human anti HER3 monoclonal antibody” NCT04699630 ↗ |
| Route | Intravenous | “administered via intravenous (IV) solution” NCT02980341 ↗ |
| Target | ERBB3 | “a human immunoglobulin G1 monoclonal antibody to HER3 (patritumab)” PMID 40554742 ↗ Jun 2025 |
| Target | TOP1 | “DNA topoisomerase I inhibitor” CHEMBL4594611 ↗ |