30P - Proteomic signature analysis and application in clinical development of the novel phosphatidylserine-targeting immunotherapy, bavituximab

Date 05 November 2016
Event ESMO Symposium on Immuno-Oncology 2016
Session Lunch and general poster viewing
Presenter David Gerber
Citation Annals of Oncology (2016) 27 (suppl_8): viii4-viii17. 10.1093/annonc/mdw527
Authors D.E. Gerber1, N.L. Kallinteris2, L. Horn3, G. Losonczy4, R. Natale5, H. Roder6, M. Tang7, J. Lai2, J. Shan8, R. Sanborn9
  • 1Oncology, University of Texas Southwestern Medical Center at Dallas, 75390 - Dallas/US
  • 2Clinical, Peregrine Pharmaceuticals Inc., Tustin/US
  • 3Oncology, Vanderbilt Ingram Cancer Center, 37232-6307 - Nashville/US
  • 4Oncology, Semmelweis University, Budapest/HU
  • 5Oncology, Cedars-Sinai Medical Center, Los Angeles/US
  • 6Cto, Biodesix, Boulder/US
  • 7Biostatistics, Peregrine Pharmaceuticals Inc., Tustin/US
  • 8Clinical & Regulatory Affairs, Peregrine Pharmaceuticals, Inc., 92780 - Tustin/US
  • 9Thoracic Oncology, Providence Cancer Care, Providence/US

Abstract

Aim/Background

Understanding the multi-dimensional characteristics of cancer is essential to patient selection and treatment planning. Topline results from SUNRISE, a global double-blind Phase III trial of docetaxel + bavituximab (D+B) vs. docetaxel + placebo (D) in previously treated non-squamous non-small cell lung cancer (NSCLC) demonstrated median overall survival (mOS) of 10.7 months in the D+B group and 10.8 months for the D group, which was unexpectedly different from the assumed 9.1 months mOS for D+B vs. 7.0 months mOS used for study powering. VeriStrat®, a commercially available blood-based proteomic test for patients with advanced NSCLC was retrospectively performed on patient samples from SUNRISE. Proteomic approaches are also being used for the development of a potential new immunoclassifier specific for bavituximab.

Methods

Pre-treatment serum samples from all 597 SUNRISE patients were tested for protein expression using mass spectrometry, classifying patients as VeriStrat (VS) Poor (correlates with a more aggressive disease) or VS Good (correlates with a more favorable prognosis). OS was analyzed by VeriStrat subgroups using Kaplan-Meier statistical methods.

Results

VeriStrat classification was available for 569 patients. In the D+B group, 80% were VS Good and 20% were VS Poor. In the D group 84% were VS Good and 16% were VS Poor. Median overall survival (mOS) in all VS Good is 11.5 months (95% confidence interval [CI], 10.6-12.9) and 5.7 (95% CI, 4.2-7.2) in all VS Poor; p 

Conclusions

VeriStrat results in SUNRISE are overall prognostic for OS, but not predictive for bavituximab treatment response. The unexpected OS result in the docetaxel arm of SUNRISE may have been impacted by the relatively high overall proportion of VeriStrat Good patients. The development of a unique blood-based immunoclassifier for bavituximab is underway and might be useful for patient selection in future clinical studies.

Clinical trial identification

PPHM 1202 - SUNRISE Trial NIH # - NCT01999673

Legal entity responsible for the study

Peregrine Pharmaceuticals Inc.

Funding

Peregrine Pharmaceuticals Inc.

Disclosure

D.E. Gerber: Research funding – Peregrine. N.L. Kallinteris, M. Tang, J. Lai: Peregrine employee. L. Horn: Advisory board Genentech, Merck, Lilly, Abbvie, BI. Consulting unpaid Xcovery, Bayer, BMS. H. Roder: Biodesix employee. J. Shan: Peregrine employee and officer. R. Sanborn: Advisory Boards: Seattle Genetics, Peregrine Pharmaceuticals, ARIAD. Institutional research funding: Bristol-Myers Squibb, MedImmune. Honoraria: AstraZeneca. All other authors have declared no conflicts of interest.