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Association details:
| Biomarker: | EGFR mutation |
|---|---|
| Cancer: | Non Small Cell Lung Cancer |
| Drug: | datopotamab deruxtecan (DS-1062a) (Topoisomerase I inhibitor, TROP-2-targeted antibody-drug conjugate) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Datopotamab (DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Excerpt:
...Participants who have known EGFR, BRAF, and MET mutation or ALK, ROS1, RET,...
Trial ID:
Source:
Title:
Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer With or Without Actionable Genomic Alterations (TROPION-LUNG01)
Excerpt:
...- Participants who have tumors with EGFR L858R or exon 19 deletion mutations must have received prior Osimertinib....
Trial ID:
More C2 evidence
Source:
Title:
Study of DS-1062a in Advanced or Metastatic Non-small Cell Lung Cancer With Actionable Genomic Alterations (TROPION-Lung05)
Excerpt:
...Overexpression of EGFR, in the absence of activating mutations, is NOT sufficient for enrollment....
Trial ID:
Source:
Title:
Study to evaluate the efficacy of DS-1062a in patients with advanced lung cancer with analyzes of biomarkers associated with response to treatment.
Excerpt:
...For patients who have known EGFR, BRAF, and MET mutation or ALK, ROS1, RET, NTRK fusion (if available): they must have progressed after one line of an approved targeted agent and one platinum-doublet regimen.4. ...
Trial ID:
Less C2 evidence
Source:
Title:
552P - TROPION-Lung05: Datopotamab deruxtecan (Dato-DXd) in Asian patients (pts) with previously treated non-small cell lung cancer (NSCLC) with actionable genomic alterations (AGAs)
Published date:
11/27/2023
Excerpt:
Of 137 pts, 66 were from Asia and received ≥1 dose; 68.2% had ≥3 prior lines of therapy for a/m NSCLC; 71.2% had EGFRm...ORR was 42.4% (48.9% in EGFRm pts); mDOR by BICR was 4.4 mo, DCR was 80.3%, and mPFS was 5.4 mo (Table)...Dato-DXd showed encouraging antitumor activity, with clinically meaningful responses in a heavily pretreated Asian pt subpopulation.
Trial ID:
Source:
Title:
518MO - TROPION-Lung05: Datopotamab deruxtecan (Dato-DXd) in previously treated non-small cell lung cancer (NSCLC) with actionable genomic alterations (AGAs)
Published date:
11/27/2023
Excerpt:
Median pt duration on study was 15.2 months (mo); cORR was 35.8%, DCR, 78.8%, and median DOR, 7.0 mo; similar response was seen in pts with EGFR mutations...Dato-DXd showed encouraging antitumor activity, with a clinically meaningful and durable response, in heavily pretreated pts with NSCLC with AGAs...
Trial ID:
Source:
Title:
1314MO - TROPION-Lung05: Datopotamab deruxtecan (Dato-DXd) in previously treated non-small cell lung cancer (NSCLC) with actionable genomic alterations (AGAs)
Published date:
10/16/2023
Excerpt:
A total of 137 pts received ≥1 dose and had a median age of 61.0 y; 71.5% had ≥3 prior lines of therapy for a/m NSCLC; 56.9% had EGFR mutations...Median pt duration on study was 15.2 months (mo); cORR was 35.8%, DCR, 78.8%, and median DOR, 7.0 mo; similar response was seen in pts with EGFR mutations...Dato-DXd showed encouraging antitumor activity, with a clinically meaningful and durable response, in heavily pretreated pts with NSCLC with AGAs. The safety profile was manageable and consistent with prior safety observed with Dato-DXd. These data support inclusion of pts with AGAs in the TROPION-Lung01 study.
Trial ID:
