ePoster Display session ePoster

4P - Immunohybridoma cell-based vaccine for the treatment of patients with castration-resistant prostate cancer (ID 310)

Presentation Number
4P
Lecture Time
08:40 - 08:40
Speakers
  • Simon Hawlina (Ljubljana, Slovenia)
Session Name
ePoster Display session
Room
ePoster gallery
Date
Tue, 02.03.2021
Time
08:00 - 20:00
Authors
  • Simon Hawlina (Ljubljana, Slovenia)
  • Helena H. Chowdhury (Ljubljana, Slovenia)
  • Mateja Gabrijel (Ljubljana, Slovenia)
  • Saša Trkov Bobnar (Ljubljana, Slovenia)
  • Marko Kreft (Ljubljana, Slovenia)
  • Gordan Lenart (Ljubljana, Slovenia)
  • Marko Cukjati (Ljubljana, Slovenia)
  • Andreja N. Kopitar (Ljubljana, Slovenia)
  • Alojz Ihan (Ljubljana, Slovenia)
  • Luka Ležaić (Ljubljana, Slovenia)
  • Marko Gamek (Ljubljana, Slovenia)
  • Andrej Kmetec (Ljubljana, Slovenia)
  • Matjaž Jeras (Ljubljana, Slovenia)
  • Robert Zorec (Ljubljana, Slovenia)

Abstract

Background

Treatments of various forms of cancer with in vitro prepared dendritic cells of various modalities have been shown to be safe but have not led to the desired efficacy. In this study, we examined the safety and efficacy of an autologous vaccine based on the fusion of patient tumor and dendritic cells (aHyC) in the treatment of chemotherapy-naive patients with castration-resistant prostate cancer (CRPC).

Methods

A randomized placebo-controlled cross-over trial was conducted between June 2013 and November 2016 and followed up for survival until September 2020. Twenty-two adult men with CRPC, asymptomatic or minimally symptomatic were enrolled and consecutively allocated to aHyC-first (12 patients) and placebo-first (10 patients) group according to previous randomization. Two patients were excluded during the trial. Autologous monocyte-derived dendritic cells and prostate tumor cells were electrofused to yield hybridomas and injected subcutaneously four times. The primary endpoints were safety, feasibility and quality of life assessments; the secondary endpoints were patients’ clinical and immune responses and overall survival.

Results

Twenty patients were analyzed. There were no serious adverse events (AEs) with aHyC treatment; mild AEs were observed in five patients in the aHyC arm (42%) and in three patients in the placebo arm (38%; P=0.78). The aHyC treatment preserved quality of life in the observed period of 4 months after the first application of aHyC vaccine. An increase in CD4+ cell subpopulations, an increase in cytotoxic T cells (CD8+), and a decrease in total NK cells were detected only in the aHyC arm compared to baseline. Moreover, the natural killer cell subpopulation remained at basal level, but increased in the placebo arm (P=0.004). The median overall survival from the first aHyC application was 58.5 months (95% CI, 45.4 to 71.7; n=19) and 65.2 months from CRPC diagnosis. The median time to next-in-line therapy (docetaxel, enzalutamide, abiraterone acetate) in patients receiving aHyC (n=19) was 28.0 months.

Conclusions

Treatment with aHyC is safe and effective and may represent a new personalized therapeutic option for patients with CRPC.

Clinical trial identification

EMA: 2012-005498-29.

Legal entity responsible for the study

Robert Zorec.

Funding

This work was supported by grants P3 310, J3 6790, J3 6789, and J3 9266 from the Slovenian Research Agency; by CipKeBip, COST Action BM1002, EU COST Action CM1207-GLISTEN, and EU COST Action CM1207 EuroCellNet.

Disclosure

All authors have declared no conflicts of interest.

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