A Randomized Phase 2 Study Comparing the Combination of Ficlatuzumab and Gefitinib with Gefitinib Alone in Asian Patients with Advanced Stage Pulmonary Adenocarcinoma
Publication in refereed journal


Times Cited
Web of Science25WOS source URL (as at 21/11/2020) Click here for the latest count
Scopus (as at 21/11/2020)
Altmetrics Information
.

Other information
AbstractINTRODUCTION:
A randomized phase 2 study was designed to compare the combination of ficlatuzumab (AV-299), a humanized hepatocyte growth factor-neutralizing monoclonal antibody, plus gefitinib versus gefitinib monotherapy in a pulmonary adenocarcinoma population clinically enriched for EFGR tyrosine kinase inhibitor-sensitizing mutations.
METHODS:
A total of 188 patients were randomized 1:1 to receive either gefitinib or ficlatuzumab plus gefitinib treatment. Patients who demonstrated disease control in the single-agent gefitinib arm were allowed to cross over to ficlatuzumab plus gefitinib treatment upon disease progression. Molecular analyses included tumor EGFR mutation status and retrospective proteomic testing using VeriStrat, a multivariate test based on mass spectrometry.
RESULTS:
The addition of ficlatuzumab to gefitinib did not provide significant improvement over gefitinib monotherapy for the primary end point of overall response rate or the secondary end points of progression-free survival and overall survival. In the subgroup classified as VeriStrat poor, the addition of ficlatuzumab to gefitinib showed significant improvement in both progression-free survival and overall survival in both the intent-to-treat population and the subgroup with EGFR tyrosine kinase inhibitor-sensitizing mutations. For all patients, the most frequent adverse events were diarrhea, dermatitis acneiform, and paronychia.
CONCLUSIONS:
Although the trial showed no significant benefit from the addition of ficlatuzumab to gefitinib in the overall population of Asian patients with advanced-stage pulmonary adenocarcinoma, the biomarker data suggest that patients classified as VeriStrat poor may benefit from ficlatuzumab combination therapy.
All Author(s) ListMOK Shu Kam Tony, GEATER Sarayut Lucien, SU Wu Chou, TAN Eng Huat, YANG James Chi Hsin, CHANG Gee Chen, HAN May, KOMARNITSKY Philip, PAYUMO Francis, GARRUS Jennifer E, CLOSE Sandra, PARK Keunchil
Journal nameJournal of Thoracic Oncology
Year2016
Month10
Volume Number11
Issue Number10
PublisherLippincott, Williams & Wilkins
Pages1736 - 1744
ISSN1556-0864
eISSN1556-1380
LanguagesEnglish-United Kingdom
KeywordsADVANCED STAGE PULMONARY ADENOCARCINOMA; GEFITINIB

Last updated on 2020-22-11 at 00:14