Abstract Types

CRA
Clinical Review Abstract

LBA
Late-Breaking Abstract

TPS
Trials in Progress Abstract

e
Abstracts selected for publication but not presentation at the Annual Meeting

^
Abstracts granted an exception in accordance with ASCO's Conflict of Interest Policy



A randomized, open-label phase II study of single-agent vintafolide versus vintafolide plus docetaxel versus docetaxel alone in second-line NSCLC patients with all target lesions expressing folate-receptor (TARGET).

Sub-category:
Metastatic Non-small Cell Lung Cancer

Category:
Lung Cancer - Non-small Cell Metastatic

Meeting:
2013 ASCO Annual Meeting

Abstract No:
TPS8125

Citation:
J Clin Oncol 31, 2013 (suppl; abstr TPS8125)

Publication-only abstracts (abstract number preceded by an "e"), published in conjunction with the 2013 Annual Meeting but not presented at the Meeting, can be found online only.

Author(s): Martin J. Edelman, Hong Ma, Wendy Perez, Alex A. Adjei, Nasser Hanna; University of Maryland, Marlene and Stewart Greenebaum Cancer Center, Baltimore, MD; Endocyte, Inc., West Lafayette, IN; Roswell Park Cancer Institute, Buffalo, NY; Simon Cancer Center, Indiana University School of Medicine, Indianapolis, IN

Abstract Disclosures


Abstract:

Background: Folate receptor (FR) is frequently overexpressed in NSCLC and is a potential biomarker for therapy selection. Vintafolide (EC145) is designed to target FR expressing cells and consists of folate linked to desacetylvinblastinehydrazide. The FR targeted imaging agent, 99mTc-etarfolatide (EC20), consists of folate coupled to technetium and identifies lesions that overexpress FR which may respond to vintafolide treatment. A phase II study of single-agent vintafolide in heavily pre-treated lung adenocarcinoma patients (pts) showed promising activity in clinical benefit response (50% vs. 14.3%) and overall survival (OS, 47.2 wks vs. 14.9 wks), in pts whose target lesions all expressed FR [FR (100%)] vs pts whose target lesions were not all FR positive (Edelman et al, JTO 2012:7:1618-21). This trial assesses the benefit of vintafolide as second-line therapy in NSCLC FR (100%) pts. Methods: This is a randomized, open-label phase II study of vintafolide vs. vintafolide + docetaxel vs. docetaxel in second line NSCLC FR (100%) pts (NCT01577654). Key eligibility criteria include: cytologic or histologic diagnosis of NSCLC, 1 prior systemic therapy for advanced disease, and PS 0-1. At baseline, pts undergo 99mTc-etarfolatide imaging to detect FR-positive lesions. FR (100%) pts are randomized 1:1:1 to vintafolide, vintafolide + docetaxel, or docetaxel. Vintafolide (2.5 mg) is administered on d 1, 4, 8, and 11 of a 3-wk cycle. Docetaxel (75 mg/m2) is given on d 1 of a 3-wk cycle. Treatment continues until disease progression or unacceptable toxicity. Pts receiving vintafolide + docetaxel who discontinue docetaxel due to toxicity may continue vintafolide alone. Disease status is evaluated by RECIST v1.1 criteria every 6 wks and adverse events are monitored throughout. The primary objective of this study compares PFS between the docetaxel control arm and each experimental arm with the goal of demonstrating a hazard ratio of ≤0.67 favoring the experimental arms. Secondary objectives include response rate, disease control rate, OS, and safety/tolerability. Enrollment to the study is ongoing. Clinical trial information: NCT01577654.

 

  Other Abstracts in this Sub-Category:

 

1. Biomarkers (BM) France: Results of routine EGFR, HER2, KRAS, BRAF, PI3KCA mutations detection and EML4-ALK gene fusion assessment on the first 10,000 non-small cell lung cancer (NSCLC) patients (pts).

Meeting: 2013 ASCO Annual Meeting Abstract No: 8000 First Author: F. Barlesi
Category: Lung Cancer - Non-small Cell Metastatic - Metastatic Non-small Cell Lung Cancer

 

2. Molecular analysis-directed, international, phase III trial in patients with advanced non-small-cell lung cancer.

Meeting: 2013 ASCO Annual Meeting Abstract No: 8001 First Author: G. Bepler
Category: Lung Cancer - Non-small Cell Metastatic - Metastatic Non-small Cell Lung Cancer

 

3. Interim analysis of the Spanish Lung Cancer Group (SLCG) BRCA1-RAP80 Expression Customization (BREC) randomized phase III trial of customized therapy in advanced non-small cell lung cancer (NSCLC) patients (p) (NCT00617656/GECP-BREC).

Meeting: 2013 ASCO Annual Meeting Abstract No: LBA8002 First Author: T. Moran
Category: Lung Cancer - Non-small Cell Metastatic - Metastatic Non-small Cell Lung Cancer

 

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