Dendritic cell vaccine (DCVAC) with chemotherapy (ct) in patients (pts) with recurrent epithelial ovarian carcinoma (EOC) after complete response (CR) to 1st-line platinum (Pt)-based ct: Primary analysis of a phase 2, open-label, randomized, multicenter trial.

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Journal: J Clin Oncol 36, 2018 (suppl; abstr e17515)
Published: 2018-06-01

Authors:
David Cibula, Peter Mallmann, Pawel Knapp, Bohuslav Melichar, Jaroslav Klat, Lubos Minar, Zdenek Novotny, Pauline Wimberger, Alexander Hein, Radek Spisek, Jirina Bartunkova, Ladislav Pecen, Hariz Iskandar Bin Hassan, Lukas Rob, SOV02 Investigators; Department of Obstetrics and Gynaecology, Charles University & General Faculty Hospital, Prague, Czech Republic; Frauenklinik (OB/GYN), University of Cologne, Cologne, Germany; Department of Gynaecologic Oncology, Medical University of Bialystok, Bialystok, Poland; Department of Oncology, Palacky University Medical School and Teaching Hospital, Olomouc, Czech Republic; University Hospital, Ostrava, Czech Republic; Department of Gynaecology and Obstetrics, Faculty Hospital, Brno, Czech Republic; GPK University Hospital, Plzen, Czech Republic; Department of Gynecology and Obstetrics, University Hospital Carl Gustav Carus, TU Dresden, Dresden, Germany; Department of Gynecology and Obstetrics, Erlangen University Hospital, Erlangen, Germany; SOTIO a.s., Prague, Czech Republic; University Hospital Motol, Prague, Czech Republic; Department of Obstetrics and Gynaecology, University Hospital Kralovske Vinohrady, Prague, Czech Republic

ABSTRACT

Background: When pts with EOC relapse, their response to subsequent therapy is reduced. We hypothesized that autologous DCVAC could potentiate the antitumor response to ct and delay progression.

Methods: Key eligibility criteria were FIGO stage III – IV EOC (serous, endometrioid, or mucinous), PS 0 – 2, CR after 1st-line Pt-based ct that lasted > 6 months, and at least 1 measurable lesion per RECISTv1.1. We randomized pts up to 6 weeks after relapse was confirmed by CT/MRI, 1:1, into arm A (A; DCVAC concomitantly with ct) and arm B (B; ct alone). Pts were stratified by previous bevacizumab use (yes/no) and duration of remission (6 – 12/ > 12 months). Ct consisted of 6 – 10 cycles of carboplatin (AUC 4 – 5; D1) and gemcitabine (1000mg/m2; D1, D8). Pts in A were to receive 10 doses of DCVAC (1 x 107 DCs/dose). The primary endpoint was investigator-assessed progression-free survival (PFS). Secondary endpoints included overall survival (OS), objective response rate (ORR), and safety.

Results: Between November 2013 and May 2015, 71 pts were randomized in 3 countries (A/B, 39/32). Median age was 58.5 years in A and 60.5 years in B. After excluding pts who failed leukapheresis or manufacturing, the intention-to-treat population included 32 pts in each arm. A mean of 9.8 doses of DCVAC were administered in A. Median follow-up time was 28.2 months (range, 23.8 – 41.6 months). Median PFS was 10.9 months in A and 9.4 months in B; HR (95% CI) = 0.74 (0.42 – 1.30), p = 0.29. The corresponding ORR (95% CI) was 87.5% (71.0% – 96.5%) in A and 62.5% (43.7% – 78.9%) in B. In November 2017, median OS was not reached in A, while it was 30 months in B (44% events); HR (95% CI) = 0.62 (0.29 – 1.34). The majority of adverse events (AEs) were related to ct (thrombocytopenia [A: 64.9%, B: 80.6%], anemia [A: 64.9%, B: 67.7%], neutropenia [A: 59.5%, B: 67.7%], and leukopenia [A: 45.9%, B: 32.3%]). There were no grade ≥ 3 AEs related solely to DCVAC. Most common leukapheresis-related AEs were mild pyrexia and moderate hypocalcemia.

Conclusions: Primary analysis showed better ORR and a trend towards improved OS in the DCVAC arm. Clinical trial information: NCT02107950

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