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Poster display session

1611 - Results of the randomized, placebo-controlled phase I/IIB trial of CV9104, an mRNA based cancer immunotherapy, in patients with metastatic castration-resistant prostate cancer (mCRPC)

Date

10 Sep 2017

Session

Poster display session

Topics

Clinical Research;  Cancers in Adolescents and Young Adults (AYA);  Immunotherapy;  Prostate Cancer

Presenters

Arnulf Stenzl

Citation

Annals of Oncology (2017) 28 (suppl_5): v403-v427. 10.1093/annonc/mdx376

Authors

A. Stenzl1, S. Feyerabend2, I. Syndikus3, T. Sarosiek4, H. Kübler5, A. Heidenreich6, R. Cathomas7, C. Grüllich8, Y. Loriot9, J.L. Perez Gracia10, U. Klinkhardt11, A. Schroeder11, O. Schönborn-Kellenberger12, V. Reus13, V. Reus11, S.D. Koch14, H.S. Hong14, T. Seibel11, K. Fizazi15, U. Gnad-Vogt11

Author affiliations

  • 1 Dep. Of Urology, Eberhard-Karls-University, 72076 - Tübingen/DE
  • 2 Urologic Oncology, Studienpraxis Urologie, Reutlingen/DE
  • 3 Clatterbridge Cancer Center, Clatterbridge Cancer Center, Bebington/GB
  • 4 Department Of Oncology, NZOZ Magodent Centrum Medyczne Ostrobramska, Warsaw/PL
  • 5 Urology Department, University hospital, Würzburg/DE
  • 6 Klinik Für Urologie, University Hospital Cologne, Köln/DE
  • 7 Internal Medicine Hematology/oncology, Kantonsspital Graubünden, Chur/CH
  • 8 Medical Oncology, University Hospital Heidelberg, Heidelberg/DE
  • 9 Medical Oncology Department, Institut Gustave Roussy, 94800 - Villejuif/FR
  • 10 Medical Oncology, Clinica Universitaria de Navarra, 31008 - Pamplona/ES
  • 11 Clinical Development, CureVac AG, Frankfurt/DE
  • 12 Biostatistics, Cogitars GmbH, Heidelberg/DE
  • 13 Clinical Development, CureVac AG, 60325 - Frankfurt/DE
  • 14 Biomarkers & Immunoanalysis, CureVac AG, Tübingen/DE
  • 15 Medical Oncology Department, Gustave Roussy, University of Paris Sud, 94805 - Villejuif/FR
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Resources

Abstract 1611

Background

CV9104 is a novel prostate cancer immunotherapy based on sequence-optimized, free and protamine-complexed mRNA encoding the antigens PSA, PSMA, PSCA, STEAP1, PAP and MUC1. Safety and immune responses to the predecessor therapy CV9103 encoding 4 of the antigens have been described previously. We assessed whether immunotherapy with CV9104 on top of standard of care (SOC) results in longer overall survival than placebo plus standard of care in patients with mCRPC.

Methods

After completion of a safety lead-in phase I, men with chemo-naïve, oligosymptomatic/asymptomatic mCRPC without visceral metastases were randomized 2:1 to intradermal CV9104 or placebo (P). Double-blinded treatment was continued beyond initial progression until progression under first subsequent SOC therapy or toxicity. The primary endpoint (EP) was overall survival (OS). Key secondary EPs included radiographic progression-free survival (rPFS1/rSPFS from randomization until initial progression/second progression on SOC therapy and rPFS2 from start of SOC therapy to second progression), time to symptom progression and cellular and humoral immune responses.

Results

197 patients (pt) were randomized 2:1 to either CV9104 (n = 134) or P (n = 63). Pt characteristics, median number of administrations and first subsequent SOC therapies were well balanced between the arms. No significant difference in OS was found, median (m) OS was 35.5 months (mo) [28.-NE] in the CV9104 arm vs. 33.7 mo [28.7-NE] in the P arm (hazard ratio [HR] 1.1, 95% CI 0.70-1.76; one-sided p = 0.33). There were also no significant differences in the rPFS endpoints and time to symptom progression. Incidence of Grade ≥3 AEs (51.1% vs. 59.7%) and serious AEs (44.5% vs. 43.5%) was similar in both arms, injection site reactions and flu like symptoms were more frequent in the CV9104 arm.

Conclusions

CV9104 did not improve OS compared to placebo. Additional clinical outcomes and analyses of cellular and humoral immune responses will be presented and impact on further development will be discussed.

Clinical trial identification

EudraCT number: 2011-006314-14

Legal entity responsible for the study

CureVac AG

Funding

Study Sponsor: CureVac AG

Disclosure

A. Stenzl: Membership of advisory board CureVac. A. Heidenreich: Advisory board - Astellas, Bayer Healthcare, IPSEN, Jansen Honoraria - Amgen, Astellas, Bayer, Dendreon, Ferring, IPSEN, Jansen, Sanofi, Takeda Grants - AMGEN, Astellas, Sanofi. J. Loriot: Advisor for Sanofi, Astellas, Janssen, Roche, MSD, Astra Zeneca, BMS. Research grant: Sanofi. S.L. Perez Gracia: Research funding: Curevac. Advisory Boards: Curevac. S. Gillessen: Advisory Boards/IDMC (compensated): AAA International, Active Biotech AB IDMC, Astellas Pharma, Bayer, Bristol-Myers Squibb, Clovis, Curevac, Dendreon Corporation, Ferring, GlaxoSmithKline, Innocrin Pharmaceuticals, Janssen, Cilag, MaxiVAX SA, Millennium Pharmaceuticals, Novartis, Pfizer, Orion, Roche, Sanofi Aventis Group. Advisory Boards (uncompensated): Astellas Pharma, Bayer, ESSA Pharmaceuticals Corp., Nectar, ProteoMediX, Sanofi. Speakers Bureau (compensated): Janssen, Novartis. Speakers Bureau (uncompensated): Amgen, Astellas Pharma, Bayer, Janssen, Sanofi Aventis Group. Patent: Pending patent application for a method for biomarker WO 2009138392 A1. U. Klinkhardt, V. Reus, S.D. Koch, H.S. Hong, T. Seibel, U. Gnad-Vogt: CureVaćs employee. A. Schroeder: Previous employee of CureVac AG, current employee of Merck KGaA. O. Schönborn-Kellenberger: Consultant of CureVac AG. K. Fizazi: Advisor for Amgen, Astellas, Bayer, Janssen, Takeda, Sanofi, Orion, Essa, Genentech, Astra Zeneca, Clovis. All other authors have declared no conflicts of interest.

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