Details

Autor(en) / Beteiligte

• Cibula, David
• Rob, Lukas
• Mallmann, Peter
• Knapp, Pawel
• Klat, Jaroslav
• Chovanec, Josef
• Minar, Lubos
• Melichar, Bohuslav
• Hein, Alexander
• Kieszko, Dariusz
• Pluta, Marek
• Spacek, Jiri
• Bartos, Pavel
• Wimberger, Pauline
• Madry, Radoslaw
• Markowska, Janina
• Streb, Joanna
• Valha, Petr
• Hassan, Hariz Iskandar Bin
• Pecen, Ladislav
• Galluzzi, Lorenzo
• Fucikova, Jitka
• Hrnciarova, Tereza
• Hraska, Marek
• Bartunkova, Jirina
• Spisek, Radek

Titel

Dendritic cell-based immunotherapy (DCVAC/OvCa) combined with second-line chemotherapy in platinum-sensitive ovarian cancer (SOV02): A randomized, open-label, phase 2 trial

Ist Teil von

• Gynecologic oncology, 2021-09, Vol.162 (3), p.652-660

Ort / Verlag

United States: Elsevier Inc

Erscheinungsjahr

2021

Quelle

MEDLINE

Beschreibungen/Notizen

• 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.