Therapy Detail
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| Therapy Name | Patritumab deruxtecan |
| Synonyms | |
| Therapy Description |
Patritumab deruxtecan (U3-1402) is an antibody-drug conjugate (ADC) comprising an ERBB3 (HER3) antibody and Exatecan, which once internalized may result in apoptotic cell death (PMID: 31395690, PMID: 31661465, PMID: 31471314). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Patritumab deruxtecan | U3-1402|HER3-DXd|U3 1402|U31402 | HER3 (ERBB3) Antibody 23 | Patritumab deruxtecan (U3-1402) is an antibody-drug conjugate (ADC) comprising an ERBB3 (HER3) antibody and Exatecan, which once internalized may result in apoptotic cell death (PMID: 31395690, PMID: 31661465, PMID: 31471314). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| ERBB3 over exp | Her2-receptor positive breast cancer | predicted - sensitive | Patritumab deruxtecan | Phase Ib/II | Actionable | In a Phase I/II trial (U31402-A-J101), Patritumab deruxtecan (U3-1402) therapy demonstrated safety and efficacy in previously treated metastatic ERBB2 (HER2)-positive breast cancer patients with high ERBB3 (HER3) (>/=75% membrane positivity) levels (n=14), with an objective response rate of 42.9%, disease control rate of 92.9%, with partial response in 42.9% and stable disease in 50% of patients, median progression-free survival of 11 mo, and median overall survival of 19.5 mo (PMID: 37801674; NCT02980341). | 37801674 |
| ERBB3 over exp | breast cancer | sensitive | Patritumab deruxtecan | Preclinical - Cell culture | Actionable | In a preclinical study, Patritumab deruxtecan (U3-1402) treatment inhibited growth of a breast cancer cell line overexpressing Erbb3 (Her3) in culture (PMID: 35503762). | 35503762 |
| ERBB3 over exp | triple-receptor negative breast cancer | predicted - sensitive | Patritumab deruxtecan | Phase Ib/II | Actionable | In a Phase I/II trial (U31402-A-J101), Patritumab deruxtecan (U3-1402) therapy demonstrated safety and efficacy in previously treated metastatic triple-negative breast cancer patients with high ERBB3 (HER3) (>/=75% membrane positivity) levels (n=53), with an objective response rate of 22.6%, disease control rate of 79.2%, with partial response in 22.6% and stable disease in 56.6% of patients, median progression-free survival of 5.5 mo, and median overall survival of 14.6 mo (PMID: 37801674; NCT02980341). | 37801674 |
| ERBB3 positive | colorectal cancer | sensitive | Patritumab deruxtecan | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Patritumab Deruxtecan (U3-1402) decreased viability of Erbb3 (Her3)-positive colorectal cancer cell lines in culture and induced significant tumor growth inhibition in cell line xenograft models with intermediate to high Erbb3 (Her3) expression (PMID: 31395690). | 31395690 |
| ERBB3 T355I | breast cancer | sensitive | Patritumab deruxtecan | Preclinical - Cell culture | Actionable | In a preclinical study, Patritumab deruxtecan (U3-1402) treatment inhibited growth of a breast cancer cell line expressing ERBB3 (HER3) T355I in culture (PMID: 35503762). | 35503762 |
| ERBB3 positive | Her2-receptor negative breast cancer | predicted - sensitive | Patritumab deruxtecan | Clinical Study | Actionable | In a clinical study, Patritumab deruxtecan (U3-1402) treatment demonstrated efficacy in patients with ERBB3 (HER3)-positive, ERBB2 (HER2)-negative breast cancer, resulting in increased immune infiltration as measured by a median increase of 3.5 in the CelTIL score, and an overall response rate of 45.2% (28/62, 14 complete and 14 partial responses) (PMID: 37211044; NCT04610528). | 37211044 |
| ERBB3 positive | Her2-receptor negative breast cancer | predicted - sensitive | Patritumab deruxtecan | Phase II | Actionable | In a Phase II trial, Patritumab deruxtecan (U3-1402) treatment resulted in an objective response rate (ORR) of 35%, clinical benefit rate (CBR) of 48%, median duration of response of 10 mo, and 6-mo progression-free survival (PFS) rate of 60% in ERBB3 (HER3)-positive, ERBB2 (HER2)-negative metastatic breast cancer patients, with an ORR of 46 vs 33%, CBR of 54 vs 50%, and PFS rate of 70 vs 50% in those with 25-75% vs >/=75% ERBB3 (HER3) expression (J Clin Oncol 41, 2023 (suppl 16; abstr 1004); NCT04699630). | detail... |
| ERBB3 positive | Her2-receptor negative breast cancer | predicted - sensitive | Patritumab deruxtecan | Phase Ib/II | Actionable | In a Phase I/II trial (U31402-A-J101), Patritumab deruxtecan (U3-1402) therapy demonstrated safety and efficacy in previously treated metastatic hormone receptor-positive, ERBB2 (HER2)-negative breast cancer patients expressing ERBB3 (HER3) (n=113), with an objective response rate of 30.1%, disease control rate of 80.5%, with partial response in 30.1% and stable disease in 50.4% of patients, median progression-free survival of 7.4 mo, and median overall survival of 14.6 mo (PMID: 37801674; NCT02980341). | 37801674 |
| ERBB3 P262H | breast cancer | sensitive | Patritumab deruxtecan | Preclinical - Cell culture | Actionable | In a preclinical study, Patritumab deruxtecan (U3-1402) treatment inhibited growth of a breast cancer cell line expressing ERBB3 (HER3) P262H in culture (PMID: 35503762). | 35503762 |
| ERBB3 G284R | breast cancer | sensitive | Patritumab deruxtecan | Preclinical - Cell culture | Actionable | In a preclinical study, Patritumab deruxtecan (U3-1402) treatment inhibited growth of a breast cancer cell line expressing ERBB3 (HER3) G284R in culture (PMID: 35503762). | 35503762 |
| ERBB3 V104L | breast cancer | sensitive | Patritumab deruxtecan | Preclinical - Cell culture | Actionable | In a preclinical study, Patritumab deruxtecan (U3-1402) treatment inhibited growth of a breast cancer cell line expressing ERBB3 (HER3) V104L in culture (PMID: 35503762). | 35503762 |
| ERBB3 A232V | breast cancer | sensitive | Patritumab deruxtecan | Preclinical - Cell culture | Actionable | In a preclinical study, Patritumab deruxtecan (U3-1402) treatment inhibited growth of a breast cancer cell line expressing ERBB3 (HER3) A232V in culture (PMID: 35503762). | 35503762 |
| ERBB3 over exp | prostate cancer | sensitive | Patritumab deruxtecan | Preclinical - Pdx & cell culture | Actionable | In a preclinical study, Patritumab deruxtecan (U3-1402) inhibited growth of patient-derived prostate cancer cells with high ERBB3 (HER3) expression in culture and in a patient-derived xenograft (PDX) model, but did not demonstrate anti-tumor activity in cell lines with low ERBB3 (HER3) expression (PMID: 34753775). | 34753775 |
| ERBB3 E928G | breast cancer | sensitive | Patritumab deruxtecan | Preclinical - Cell culture | Actionable | In a preclinical study, Patritumab deruxtecan (U3-1402) treatment inhibited growth of a breast cancer cell line expressing ERBB3 (HER3) E928G in culture (PMID: 35503762). | 35503762 |
| ERBB3 D297Y | breast cancer | sensitive | Patritumab deruxtecan | Preclinical - Cell culture | Actionable | In a preclinical study, Patritumab deruxtecan (U3-1402) treatment inhibited growth of a breast cancer cell line expressing ERBB3 (HER3) D297Y in culture (PMID: 35503762). | 35503762 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT04699630 | Phase II | Patritumab deruxtecan | A Study of U3-1402 (Patritumab Deruxtecan) in Subjects With Metastatic Breast Cancer | Recruiting | USA | 0 |
| NCT04965766 | Phase II | Patritumab deruxtecan | Patritumab Deruxtecan (U3-1402) in Unresectable Locally Advanced or Metastatic Breast Cancer (ICARUS-BREAST) | Recruiting | FRA | 0 |
| NCT04676477 | Phase I | Patritumab deruxtecan Osimertinib + Patritumab deruxtecan | HER3-DXd (Patritumab Deruxtecan; U3-1402) in Combination With Osimertinib in Subjects With Locally Advanced or Metastatic EGFR-mutated Non-Small Cell Lung Cancer | Recruiting | USA | 3 |
| NCT05338970 | Phase III | Patritumab deruxtecan | HERTHENA-Lung02: A Study of Patritumab Deruxtecan Versus Platinum-based Chemotherapy in Metastatic or Locally Advanced EGFRm NSCLC After Failure of EGFR TKI Therapy | Active, not recruiting | USA | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS | 10 |
| NCT06172478 | Phase II | Patritumab deruxtecan | A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors | Recruiting | USA | 2 |
| NCT03260491 | Phase I | Patritumab deruxtecan | HER3-DXd in Metastatic or Unresectable Non-Small Cell Lung Cancer | Recruiting | USA | NLD | ESP | 3 |
| NCT06099639 | Expanded access | Patritumab deruxtecan | Medical Access Program for Patritumab Deruxtecan | Available | USA | 0 |
| NCT05865990 | Phase II | Patritumab deruxtecan | HER3-DXd in Breast Cancer and NSCLC Brain Metastases and Solid Tumor Leptomeningeal Disease (TUXEDO-3) | Recruiting | ESP | AUT | 0 |
| NCT04479436 | Phase II | Patritumab deruxtecan | A Study to Evaluate U3-1402 in Subjects With Advanced or Metastatic Colorectal Cancer | Terminated | USA | ITA | GBR | FRA | ESP | BEL | 2 |
| NCT04619004 | Phase II | Patritumab deruxtecan | HERTHENA-Lung01: Patritumab Deruxtecan in Subjects With Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer | Active, not recruiting | USA | NLD | ITA | GBR | FRA | ESP | DEU | BEL | AUT | AUS | 6 |
| NCT05569811 | Phase II | Letrozole + Patritumab deruxtecan Patritumab deruxtecan | NeoadjuVAnt muLti-agENT Chemotherapy or Patritumab Deruxtecan With or Without endocrINE Therapy for High-risk HR+/HER2- Breast Cancer - VALENTINE Trial (VALENTINE) | Active, not recruiting | ESP | 0 |
| NCT05620914 | Phase I | Patritumab deruxtecan | A Window of Opportunity Study of Patritumab Deruxtecan in Patients With Brain Metastases (PARAMETer) | Not yet recruiting | USA | 0 |
| NCT04610528 | Phase I | Patritumab deruxtecan | A Window-of-opportunity Study of U3-1402, a HER3-targeting Antibody-drug Conjugate in Operable Breast Cancer According to ERBB3 Expression (TOT-HER3) | Active, not recruiting | ESP | 0 |
| NCT02980341 | Phase Ib/II | Patritumab deruxtecan | Phase I/II Study of U3-1402 in Subjects With Human Epidermal Growth Factor Receptor 3 (HER3) Positive Metastatic Breast Cancer | Completed | USA | 1 |
| NCT06298084 | Phase Ib/II | Patritumab deruxtecan Olaparib + Patritumab deruxtecan | Dose-Expansion Modular Study To Explore the Safety, Tolerability, and Anti-tumor Activity of HER3- DXd Monotherapy and Combinations in Patients With Inoperable Advanced Breast Cancer (ABC) After Progression on T-DXd (ICARUSBREAST02) | Recruiting | FRA | 0 |
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