Non Small Cell Lung Cancer - U3-1402 - EGFR L858R

Association details:

Biomarker:	EGFR L858R
Cancer:	Non Small Cell Lung Cancer
Drug:	patritumab deruxtecan (U3-1402) (Topoisomerase I inhibitor, HER3-targeted antibody-drug conjugate)
Direction:	Sensitive

Evidence:

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrials.gov

Title:

HERTHENA-Lung01: Patritumab Deruxtecan in Subjects With Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer

Excerpt:

...- Documentation of an EGFR-activating mutation detected from tumor tissue or blood sample: exon 19 deletion or L858R....

Trial ID:

HERTHENA-Lung01

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrialsregister.eu

Title:

Patritumab Deruxtecan in Subjects with Metastatic or Locally Advanced EGFR-mutated NSCLC

Excerpt:

...Documentation of an EGFR-activating mutation detected from tumor tissue or blood sample: exon 19 deletion or L858R. ...

Trial ID:

2020-000730-17

More C2 evidence

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrials.gov

Title:

Patritumab Deruxtecan in Combination With Osimertinib in Subjects With Locally Advanced or Metastatic EGFR-mutated Non-Small Cell Lung Cancer

Excerpt:

...- Documentation of EGFR exon 19 deletion or L858R mutation detected from tumor tissue...

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrials.gov

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 (including G719X, exon 19 deletion, L858R, L861Q) 2....

Trial ID:

U31402-A-U102

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrials.gov

Title:

Medical Access Program for Patritumab Deruxtecan

Excerpt:

...- Documentation of an EGFR-activating mutation detected from tumor tissue or blood (exon 19 deletion or L858R mutation)....

Trial ID:

NCT06099639

Evidence Level:

Sensitive: C3 – Early Trials

Source:

J Clin Oncol

Title:

HERTHENA-Lung01, a Phase II Trial of Patritumab Deruxtecan (HER3-DXd) in Epidermal Growth Factor Receptor–Mutated Non–Small-Cell Lung Cancer After Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and Platinum-Based Chemotherapy

Published date:

09/10/2023

Excerpt:

HERTHENA-Lung01 (ClinicalTrials.gov identifier: NCT04619004) is a multicenter, open-label, randomized, two-arm, phase II study of HER3-DXd once every 3 weeks in previously treated patients with locally advanced or metastatic NSCLC with EGFR-activating mutations (exon 19 deletion or L858R) being conducted in 122 location...HER3-DXd once every 3 weeks demonstrated clinically meaningful efficacy, including durable intracranial responses, with a manageable safety profile in patients with previously treated EGFR-mutated NSCLC.

DOI:

10.1200/JCO.23.01476

Trial ID:

HERTHENA-Lung01

Evidence Level:

Sensitive: C3 – Early Trials

Source:

J Clin Oncol

Title:

Safety and preliminary antitumor activity of U3-1402: A HER3-targeted antibody drug conjugate in EGFR TKI-resistant, EGFRm NSCLC.

Excerpt:

...U3-1402 safety/tolerability and preliminary activity in metastatic or unresectable EGFRm NSCLC patients...10 pts had EGFR exon 19 deletion and 5 EGFR L858R mutation....U3-1402 showed a manageable safety profile and preliminary antitumor activity in EGFR TKI-resistant EGFRm NSCLC.

DOI:

10.1200/JCO.2019.37.15_suppl.9010

Trial ID:

U31402-A-U102