stapuldencel-T (DCVAC/PCa) / Sotio - LARVOL DELTA

Efficacy and Safety of Autologous Dendritic Cell-Based Immunotherapy, Docetaxel, and Prednisone vs Placebo in Patients With Metastatic Castration-Resistant Prostate Cancer: The VIABLE Phase 3 Randomized Clinical Trial. (PubMed, JAMA Oncol) - P3 | "The stratification was applied according to geographical region (US or non-US), prior therapy (abiraterone, enzalutamide, or neither), and Eastern Cooperative Oncology Group performance status (0-1 or 2). In this phase 3 randomized clinical trial, DCVAC/PCa combined with docetaxel plus prednisone and continued as maintenance treatment did not extend OS in patients with mCRPC and was well tolerated. ClinicalTrials.gov Identifier: NCT02111577."

Clinical • Journal • P3 data • Alopecia • Fatigue • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

DCVAC/PCa use alongside chemotherapy shows no additional mCRPC survival benefit (Medicine Matters Oncology) - "The active autologous dendritic cell-based immunotherapy...Nicholas Vogelzang...VIABLE trial say that 'factors associated with the efficacy of immunotherapy should be identified to better select patients and thus prolong OS...Vogelzang et al also report that 'DCVAC/PCa was well tolerated without any observed systemic...spur thought and guide development that may ultimately lead us down more fruitful pathways to effective therapies.'"

Media quote

A Phase I/II, Safety Clinical Trial of DCVAC/PCa and ONCOS-102 in Men With Metastatic Castration-resistant Prostate Cancer (clinicaltrials.gov) - P1/2; N=5; Terminated; Sponsor: Sotio a.s.; N=15 ➔ 5; Trial completion date: Dec 2021 ➔ Jan 2021; Recruiting ➔ Terminated; Trial primary completion date: Dec 2021 ➔ Jan 2021; insufficient accrual

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Phase I/II, Safety Clinical Trial of DCVAC/PCa and ONCOS-102 in Men With Metastatic Castration-resistant Prostate Cancer (clinicaltrials.gov) - P1/2; N=15; Recruiting; Sponsor: Sotio a.s.; Trial completion date: Apr 2021 ➔ Dec 2021; Trial primary completion date: Apr 2020 ➔ Dec 2021

Clinical • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

BioLife Solutions CryoStor cited in new journal article on results of Phase I/II clinical trial of dendritic cell immunotherapy for prostate cancer (Oncotarget) - "BioLife Solutions...today announced that a new clinical article citing the use of the Company's CryoStor cryopreservation freeze media with a dendritic cell based vaccine was published in the journal Oncotarget." 

P1/2 data • Prostate Cancer

VIABLE: Phase III Study of DCVAC Added to Standard Chemotherapy for Men With Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov) - P3; N=1170; Completed; Sponsor: Sotio a.s.; Active, not recruiting ➔ Completed; Trial completion date: Jun 2020 ➔ Jan 2020

Clinical • Trial completion • Trial completion date

Emerging therapeutic targets for patients with advanced prostate cancer. (PubMed, Cancer Treat Rev) - "Further, we outline current approaches for novel prostate cancer vaccines such as DCVAC/PCa, PROSTVAC-V/F, MVI-816, CV9104, and PF-06753512. This wide spectrum of potential treatment strategies holds promise for additional improvements in the treatment of patients with CRPC, as these novel agents are aimed at targets known to be associated with growth and malignant progression of prostate cancer. If primary study endpoints are met, findings from ongoing phase III trials of well-tolerated and active combinations may provide new effective treatment options for advanced prostate cancer and thereby contribute to enhanced disease control in CRPC patients."

Clinical • Journal • Review

VIABLE: Phase III Study of DCVAC Added to Standard Chemotherapy for Men With Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov) - P3; N=1170; Active, not recruiting; Sponsor: Sotio a.s.; Trial primary completion date: Dec 2018 ➔ Dec 2019

Clinical • Trial primary completion date