Date: 2014-09-29
Type of information: Presentation of results at a congress
phase:
Announcement: presentation of results at the 2014 Congress of the European Society for Medical Oncology (ESMO)
Company: Aveo Oncology (USA - MA) Biodesix (USA - CO)
Product: VeriStrat®
Action
mechanism: VeriStrat, developed by Biodesix, is a multivariate, blood-based, protein test currently available to help physicians guide treatment decisions for patients with advanced non-small cell lung cancer. The test identifies patients who are likely to have “Good” or “Poor” outcomes after treatment with either epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) therapy such as erlotinib or with chemotherapy. VeriStrat is based on Biodesix’ proprietary proteomics platform which enables the discovery of multivariate classifiers that characterize a patient’s condition or likely outcome in response to therapy.
Disease: non-small cell lung cancer
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: * On September 29, 2014, Aveo Oncology and Biodesix announced the presentation of results from a retrospective exploratory analysis using VeriStrat®, a commercially available serum protein test, to identify patients most likely to benefit from the addition of ficlatuzumab, Aveo’s HGF inhibitory antibody, to epidermal growth factor receptor (EGFR) tyrosine-kinase inhibitor (TKI) therapy in a randomized Phase 2 study of ficlatuzumab and gefitinib (IRESSA®) in previously untreated Asian subjects with non-small cell lung cancer (NSCLC). The results, presented in a poster session (abstract #8195) at the 2014 Congress of the European Society for Medical Oncology (ESMO), suggest that VeriStrat® may be selective of positive clinical response for ficlatuzumab plus gefitinib over gefitinib alone. A total of 188 patients were enrolled in a randomized Phase 2 study (P6162) designed to compare the combination of ficlatuzumab and gefitinib with gefitinib alone in treatment-naïve Asian patients with non-small cell lung adenocarcinoma. For this retrospective exploratory analysis, 180 serum samples were assigned a VeriStrat label of either “Good” (VSG) or “Poor” (VSP) (VSG=145, VSP=35). While the study failed to demonstrate improved overall survival (OS) or progression-free survival (PFS) over gefitinib alone in the intent-to-treat population, the addition of ficlatuzumab to gefitinib provided significant clinical benefit to the VSP subgroup: VSP ficlatuzumab and n=18 gefitinib alone n=17 OS Median 23.9 months 5.8 months Hazard Ratio 0.41 p-value 0.032 PFS Median 7.4 months 2.3 months Hazard Ratio 0.41 p-value 0.014 VSP and EGFRm ficlatuzumab and n=5 gefitinib alone n=6 OS Median 17.8 months 10.4 months Hazard Ratio 0.3 p-value 0.09 PFS Median 11.1 months 2.3 months Hazard Ratio <0.01 p-value <0.01 Based on these data, in April 2014, Aveo and Biodesix® entered into a worldwide agreement to develop and commercialize ficlatuzumab with a Biodesix companion diagnostic test. As part of this agreement, Aveo and Biodesix plan to conduct a confirmatory Phase 2 study using a Biodesix VeriStrat “Poor” classification as a selective biomarker for the combination of ficlatuzumab and an EGFR-TKI, versus an EGFR TKI alone, in previously untreated, EGFR mutation-positive patients with advanced non-small-cell lung cancer. The study is expected to initiate before year-end.
gefitinib
No benefit was observed in the VSG subgroup in either OS (Median 24.7 mo for ficlatuzumab + gefitinib [n=69] vs not reached for gefitinib alone [n=76]; HR 1.18, p=0.492) or PFS (Median 5.6 mo for ficlatuzumab + gefitinib vs 5.6 mo for gefitinib alone; HR 1.06, p=0.753). Despite the small sample sizes, similar patterns in OS and PFS based on VeriStrat stratification were also observed in patients with known EGFR mutations (n=71) and VSP classification (n=11).
gefitinib
