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Association details:
| Biomarker: | EGFR mutation |
|---|---|
| Cancer: | Non Small Cell Lung Cancer |
| Drug: | patritumab deruxtecan (U3-1402) (Topoisomerase I inhibitor, HER3-targeted antibody-drug conjugate) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
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
Published date:
12/22/2023
Excerpt:
Daiichi Sankyo...and Merck...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.
Source:
Title:
Patritumab Deruxtecan Granted U.S. FDA Breakthrough Therapy Designation in Patients with Metastatic EGFR-Mutated Non-Small Cell Lung Cancer
Published date:
12/23/2021
Excerpt:
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to patritumab deruxtecan (HER3-DXd), a potential first-in-class HER3 directed antibody drug conjugate (ADC), for the treatment of patients with metastatic or locally advanced EGFR-mutated non-small cell lung cancer (NSCLC) with disease progression on or after treatment with a third-generation tyrosine kinase inhibitor (TKI) and platinum-based therapies.
Source:
Title:
U3-1402 in Metastatic or Unresectable Non-Small Cell Lung Cancer
Excerpt:
...Historical confirmation that the tumor harbors an epidermal growth factor receptor (EGFR) mutation known to be associated with EGFR tyrosine kinase inhibitor (TKI) sensitivity...
Trial ID:
Source:
Title:
1319MO - Intracranial efficacy of HER3-DXd in patients with previously treated advanced EGFR-mutated NSCLC: Results from HERTHENA-Lung01
Published date:
10/16/2023
Excerpt:
HER3-DXd demonstrated efficacy in EGFR-mutated NSCLC CNS metastases, with durable responses. These data add to the growing body of evidence that systemic treatment is feasible in pts with brain metastases and support further investigation of HER3-DXd in this context.
Trial ID:
Source:
Title:
Patritumab Deruxtecan (HER3-DXd) in EGFR-Mutated NSCLC Following EGFRTKI and Platinum-Based Chemotherapy: HERTHENA-Lung01
Published date:
08/08/2023
Excerpt:
In this patient population with significant unmet need and limited therapeutic options, HER3-DXd demonstrated clinically meaningful efficacy; moreover, this study provides the first report of HER3-DXd efficacy in the CNS. The safety profile was manageable and, overall, HER3-DXd is a promising therapy for patients with previously treated EGFR-mutated NSCLC.
Source:
Title:
Patritumab Deruxtecan Continues to Show Encouraging Clinical Activity in Distinct Patient Populations with Metastatic Lung and Breast Cancer in Updated Results of Two Early Trials
Published date:
03/20/2023
Excerpt:
Patritumab deruxtecan demonstrated a median overall survival of more than 15 months, which is particularly impressive in heavily pretreated patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer...
Trial ID:
Source:
Title:
Efficacy and Safety of Patritumab Deruxtecan (HER3-DXd) in EGFR Inhibitor-Resistant, EGFR-Mutated Non-Small Cell Lung Cancer
Published date:
09/21/2021
Excerpt:
This phase 1, dose escalation/expansion study included patients with locally advanced or metastatic EGFR-mutated NSCLC with prior EGFR TKI therapy. Among 57 patients receiving HER3-DXd 5.6 mg/kg IV Q3W, the confirmed ORR by BICR (RECIST v1.1) was 39% (95% CI, 26.0-52.4), and median PFS was 8.2 (4.4-8.3) months.
DOI:
10.1158/2159-8290.CD-21-0715
Source:
Title:
Efficacy and safety of patritumab deruxtecan (HER3-DXd) in EGFR inhibitor-resistant, EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC)
Published date:
05/19/2021
Excerpt:
Confirmed ORR by BICR was 39% (22/57; 95% CI, 26.0%-52.4%; 1 CR, 21 PR, 19 SD) with 14/22 responses occurring within 3 mo of starting HER3-DXd….HER3-DXd 5.6 mg/kg IV Q3W demonstrated antitumor activity across various EGFR TKI resistance mechanisms in heavily pre-treated metastatic/locally advanced EGFRm NSCLC.
DOI:
10.1200/JCO.2021.39.15_suppl.9007
Trial ID:
Source:
Title:
LBA62 - Efficacy and safety of patritumab deruxtecan (U3-1402), a novel HER3 directed antibody drug conjugate, in patients (pts) with EGFR-mutated (EGFRm) NSCLC
Published date:
09/19/2020
Excerpt:
Patritumab deruxtecan at 5.6 mg/kg provides promising evidence of preliminary antitumor activity and safety in heavily pretreated pts with locally advanced or metastatic EGFRm NSCLC.
Trial ID:
Source:
Title:
MA21.06 - Preliminary Phase 1 Results of U3-1402 — A Novel HER3-Targeted Antibody–Drug Conjugate—in EGFR TKI-Resistant, EGFR-Mutant NSCLC
Published date:
09/10/2019
Excerpt:
U3-1402 demonstrated tolerable safety and antitumor activity in this ongoing study. Antitumor activity of U3-1402 was seen in cancers with EGFR-mediated and other resistance mechanisms. These findings support the hypothesis that targeting HER3 with U3-1402 may provide clinical benefit to patients with EGFR-mutant NSCLC with diverse mechanisms of resistance.
Source:
Title:
An HER3-targeting antibody-drug conjugate incorporating a DNA topoisomerase I inhibitor U3-1402 conquers EGFR tyrosine kinase inhibitor-resistant NSCLC
Excerpt:
Our results indicate that administration of U3-1402 alone or in combination with an EGFR-TKI may have potential as a novel therapy for EGFR-TKI-resistant EGFR-mutant NSCLC.
DOI:
10.1038/s41388-018-0517-4
