Final planned overall survival (OS) from OPTiM, a randomized Phase III trial of talimogene laherparepvec (T-VEC) versus GM-CSF for the treatment of unresected stage IIIB/C/IV melanoma (NCT00769704)

• Type of Material: Article
• Authors: Robert HI Andtbacka, Huntsman Cancer Institute; Frances A. Collichio, University of North Carolina at Chapel Hill; Thomas Amatruda, Minnesota Oncology; Neil Senzer, Mary Crowley Cancer Research Center; Jason Chesney, University of Louisville; Keith Delman, Emory University; Lynn Spitler, Northern California Melanoma Center; Igor Puzanov, Vanderbilt University Medical Center; Sanjiv Agarwala, St. Luke's University Hopsital; Mohammed Milhem, University of Iowa; Kevin Harrington, The Institute of Cancer Research and The Royal Marsden National Health Service Foundation Trust, Sutton, Surrey, UK; Mark Middleton, National Institute for Health Research Biomedical Research Center; Ai Li, Amgen Inc.; Mark Shilkrut, Amgen Inc.; Robert Coffin, Amgen; Howard Kaufman, Rutgers Cancer Institute of New Jersey
• Language: English
• Date: 2014
• Publisher: BioMed Central
• Publication Version: Final Published Version
• Copyright Statement: © 2014 I. Andtbacka et a
• License: Creative Commons Attribution 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1186/2051-1426-2-S3-P263
• Title of Journal or Parent Work: Journal for ImmunoTherapy of Cancer
• ISSN: 2051-1426
• Volume: 2
• Issue: Suppl 3
• Start Page: P263
• End Page: P263
• Keywords: overall survival; T-VEC; melanoma
• Research Categories: Health Sciences, Oncology; Health Sciences, General

Abstract

T-VEC is an oncolytic immunotherapy derived from herpes simplex virus type-1 designed to selectively replicate within tumors and to produce GM-CSF to enhance systemic antitumor immune responses. OPTiM, a randomized Phase III trial of T-VEC vs GM-CSF in patients with unresected melanoma with regional or distant metastases met the primary objective of an improvement in durable response rate (response lasting continuously for ≥6 months) with T-VEC versus GM-CSF (16% vs 2%, respectively; P<0.001). Most common adverse events with T-VEC were fatigue, chills, and pyrexia. No ≥grade 3 adverse events occurred in ≥3% of patients in either arm (Andtbacka et al., J Clin Oncol 2013,32[suppl]:LBA9008). At the primary analysis (PA) of secondary OS endpoint, with median follow-up of 44 (range, 32-59) months and 189 events in the T-VEC arm and 101 events in the GM-CSF arm, median (95%CI) OS was 23.3 (19.5-29.6) months for T-VEC and 18.9 (16.0-23.7) months for GM-CSF (hazard ratio [HR]=0.79; 95%CI = 0.62-1.00; P = 0.051) (Kaufman et al., J Clin Oncol 2014,32[suppl]:9008a). A planned analysis of OS at 3 years from the last randomization is presented here.