Also known as: HER3-DXd
Patritumab deruxtecan (HER3-DXd) is an investigational first-in-class HER3-directed antibody-drug conjugate for EGFR-mutated non-small cell lung cancer. It was developed for patients progressing after prior systemic therapies including EGFR TKIs. Regulatory reviews have occurred, but the BLA path was not approved and was subsequently withdrawn.
Recent developments in breast cancer treatment include new clinical trials for advanced disease, findings on CDK4/6 inhibitor sequencing, and discovery of genetic markers explaining drug resistance in HER2-positive breast cancer.
Former Novartis executive John Tsai has been appointed global head of R&D at Daiichi Sankyo, replacing Ken Takeshita effective April 1. Tsai brings over 25 years of leadership experience in drug development.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07286149 |
A Clinical Study of MK-1084 With Other Treatments for Non-small Cell Lung Cancer (MK-3475-01F) |
RECRUITING | PHASE1/PHASE2 |
| NCT07060807 |
A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016) |
RECRUITING | PHASE3 |
| NCT06941272 |
A Study of Patritumab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors (MK-9999-01C/LIGHTBEAM-U01) |
RECRUITING | PHASE1/PHASE2 |
| NCT06797635 |
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) |
RECRUITING | PHASE2 |
| NCT06686394 |
Study of Patritumab Deruxtecan With Other Anticancer Agents in Participants With HER2 Positive Breast Cancer That Has Spread and Cannot Be Surgically Removed (MK-1022-009) |
RECRUITING | PHASE1/PHASE2 |
| NCT06596694 |
Study of Patritumab Deruxtecan in Participants With Gastrointestinal Cancers (MK-1022-011) (HERTHENA-PanTumor02) |
RECRUITING | PHASE1/PHASE2 |
| NCT06469944 |
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) |
RECRUITING | PHASE1/PHASE2 |
| NCT06383884 |
Patritumab Deruxtecan in Patients With Solid Tumor Harboring an NRG1 Fusion |
RECRUITING | PHASE2 |
| NCT06298084 |
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 |
RECRUITING | PHASE1/PHASE2 |
| NCT05865990 |
HER3-DXd in Breast Cancer and NSCLC Brain Metastases and Solid Tumor Leptomeningeal Disease |
COMPLETED | PHASE2 |
