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Dendritic cell-based immunotherapy (DCVAC/OvCa) combined with second-line chemotherapy in platinum-sensitive ovarian cancer (SOV02): A randomized, open-label, phase 2 trial.
- Source :
-
Gynecologic Oncology . Sep2021, Vol. 162 Issue 3, p652-660. 9p. - Publication Year :
- 2021
-
Abstract
- DCVAC/OvCa is an active cellular immunotherapy designed to stimulate an immune response against ovarian cancer. We explored the safety and efficacy of DCVAC/OvCa plus carboplatin and gemcitabine in platinum-sensitive ovarian cancer. In this open-label, parallel-group, phase 2 trial (ClinicalTrials.gov number NCT02107950), patients with platinum-sensitive ovarian cancer relapsing after first-line chemotherapy were randomized to DCVAC/OvCa and chemotherapy or chemotherapy alone. DCVAC/OvCa was administered every 3–6 weeks (10 doses). Endpoints included safety, progression-free survival (PFS; primary efficacy endpoint) and overall survival (OS; secondary efficacy endpoint). Between November 2013 and May 2015, 71 patients were randomized to chemotherapy in combination with DCVAC/OvCa or to chemotherapy alone. Treatment-emergent adverse events related to DCVAC/OvCa, leukapheresis and chemotherapy occurred in six (16.2%), two (5.4%), and 35 (94.6%) patients in the DCVAC/OvCa group. Chemotherapy-related events occurred in all patients in the chemotherapy group. Seven patients in the DCVAC/OvCa group were excluded from primary efficacy analyses due to failure to receive ≥1 dose of DCVAC/OvCa. PFS was not improved (hazard ratio [HR] 0.73, 95% confidence interval [CI] 0.42–1.28, P = 0.274, data maturity 78.1%). Median OS was significantly prolonged (by 13.4 months) in the DCVAC/OvCa group (HR 0.38, 95% CI 0.20–0.74, P = 0.003; data maturity 56.3%). A signal for enhanced surrogate antigen-specific T-cell activity was seen with DCVAC/OvCa. DCVAC/OvCa combined with chemotherapy had a favorable safety profile in patients with platinum-sensitive ovarian cancer. DCVAC/OvCa did not improve PFS, but the exploratory analyses revealed OS prolongation and enhanced surrogate antigen-specific T-cell activity. • Randomized trial of DCVAC/OvCa, dendritic cell-based immunotherapy in platinum-sensitive ovarian cancer. • The addition of DCVAC/OvCa to second-line chemotherapy had a favorable safety profile. • DCVAC/OvCa did not improve progression-free survival, but did prolong overall survival by 13.4 months. • DVCAC/OvCa plus chemotherapy enhanced surrogate T-cell activity. [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 00908258
- Volume :
- 162
- Issue :
- 3
- Database :
- Academic Search Index
- Journal :
- Gynecologic Oncology
- Publication Type :
- Academic Journal
- Accession number :
- 152186978
- Full Text :
- https://doi.org/10.1016/j.ygyno.2021.07.003