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Title: Progression-free and overall survival in ovarian cancer patients treated with CVac, a mucin 1 dendritic cell therapy in a randomized phase 2 trial.
Austin Authors: Gray, H J;Benigno, B;Berek, J;Chang, J;Mason, J;Mileshkin, L;Mitchell, Paul L R ;Moradi, M;Recio, F O;Michener, C M;Secord, A Alvarez;Tchabo, N E;Chan, J K;Young, J;Kohrt, H;Gargosky, S E;Goh, J C
Affiliation: Greenslopes Private Hospital, Royal Brisbane & Women's Hospital, University of Queensland & Gallipoli Research Foundation, Greenslopes, QLD Australia
Stanford University Cancer Institute, Stanford, CA USA
Prima BioMed, Sydney, NSW Australia
University of Washington Medical Center, Seattle, WA USA
Northside Hospital, Atlanta, GA USA
Stanford Women's Cancer Center, Stanford, CA USA
Marin Cancer Care, Greenbrae, CA USA
Scripps Cancer Center, San Diego, CA USA
Peter MacCallum Cancer Centre, East Melbourne, Vic Australia
Olivia Newton-John Cancer Wellness and Research Centre, Austin Health, Heidelberg, Victoria, Australia
New York Downtown Hospital, New York, NY USA
South Florida Center for Gynecologic Oncology, Boca Raton, FL USA
Cleveland Clinic Foundation, Cleveland, OH USA
Duke Cancer Institute, Duke University Health System, Durham, NC USA
Morristown Medical Center, Morristown, NJ USA
University of California, San Francisco & Sutter Health Research Institute, San Francisco, CA USA
Medical University of South Carolina, Charleston, SC USA
Issue Date: 21-Jun-2016 2016-06-21
Publication information: Journal for immunotherapy of cancer 2016; 4: 34
Abstract: CAN-003 was a randomized, open-label, Phase 2 trial evaluating the safety, efficacy and immune outcomes of CVac, a mucin 1 targeted-dendritic cell (DC) treatment as a maintenance therapy to patients with epithelial ovarian cancer (EOC). Patients (n = 56) in first (CR1) or second clinical remission (CR2) were randomized (1:1) to standard of care (SOC) observation or CVac maintenance treatment. Ten doses were administered over 56 weeks. Both groups were followed for progression-free survival (PFS) and overall survival (OS). Fifty-six patients were randomized: 27 to SOC and 29 to CVac. Therapy was safe with only seven patients with Grade 3-4 treatment-emergent adverse events. A variable but measurable mucin 1 T cell-specific response was induced in all CVac-treated and some standard of care (SOC) patients. Progression free survival (PFS) was not significantly longer in the treated group compared to SOC group (13 vs. 9 months, p = 0.36, hazard ratio [HR] = 0.73). Analysis by remission status showed in the CR1 subgroup a median PFS of 18 months (SOC) vs. 13 months (CVac); p = 0.69 (HR = 1.18; CI 0.52-2.71). However CR2 patients showed a longer median PFS in the CVac-treated group (median PFS not yet reached, >13 vs. 5 months; p = 0.04, HR = 0.32 CI). OS for CR2 patients at 42 months of follow-up showed a difference of 26 months for SOC vs. > 42 months for CVac-treated (as median OS had not been reached; HR = 0.17 (CI 0.02-1.4) with a p = 0.07). CVac, a mucin 1-dendritic cell maintenance treatment was safe and well tolerated in ovarian cancer patients. A variable but observed CVac-derived, mucin 1-specific T cell response was measured. Notably, CR2 patients showed an improved PFS and lengthened OS. Further studies in CR2 ovarian cancer patients are warranted (NCT01068509). NCT01068509. Study Initiation Date (first patient screened): 20 July 2010. Study Completion Date (last patient observation): 20 August 2013, the last patient observation for progression-free survival; 29 April 2015, the last patient was documented regarding overall survival.
DOI: 10.1186/s40425-016-0137-x
PubMed URL: 27330807
ISSN: 2051-1426
Type: Journal Article
Subjects: Dendritic cells
Mucin 1
Ovarian cancer
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