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Full session title: A randomized, double blind, placebo controlled phase II trial to evaluate the safety and efficacy of recMAGE-A3 + AS15 antigen specific cancer immunotherapy in patients with MAGE-A3 positive muscle invasive bladder cancer after cystectomy: An initial report of the EAU Research Foundation randomized phase II clinical trial ‘Magnolia’ - Session Highlights
Radical cystectomy for muscle invasive bladder cancer (MIBC) is associated with significant morbidity and mortality. Currently adjuvant chemotherapy (AC) is advised only in clinical trials, and compliance with AC is low given significant treatment-associated morbidity. A novel immunotherapeutic, recMAGE-A3 + AS15 ASCI (antigen-specific cancer immunotherapeutic), has demonstrated efficacy in patients with metastatic melanoma and non-small cell lung carcinoma. For patients with MAGE-A3 antigen expressing bladder cancer, ASCI may represent an appealing alternative for adjuvant therapy.
Magnolia is a phase II trial of MAGE-A3 cancer immunotherapeutic in bladder cancer patients. The study is currently ongoing, and aims to accrue approximately 1 300 patients and randomize 273 patients with histologically confirmed urothelial BC (Stage pT2–3 pN0–2 cM0 or pT4 pN0 cM0) with expression of the MAGE-A3 antigen in a 2:1 ratio to receive either placebo or MAGE-A3 cancer immunotherapeutic. Primary objectives will evaluate disease-free and overall survival, the immune response, and a gene signature predictive for response to study therapy.
Thus far, 51% of patients screened express MAGE-A3, and of the patients recruited, 37% have extravesical or node-positive disease and hence are at high risk for developing disease relapse. The randomized patients are representative of the MIBC population after radical cystectomy. To date, 64 patients have received a total of 402 injections. For the patients currently enrolled, the MAGE-A3 cancer immunotherapeutic showed a clinically acceptable safety profile with no unexpected safety concerns. The Magnolia study is designed to evaluate if treatment with the MAGE-A3 immunotherapeutic can delay or prevent disease relapse in patients with MAGE-A3 positive MIBC. There have been a number of recruitment challenges, and to improve accrual, the following changes will be implemented going forward: inclusion of neo-adjuvant and adjuvant chemotherapy treated patients, broadening the time window between cystectomy and randomization from 9-13 weeks, and consideration of using TUR samples for MAGE-A3 expression testing when the cystectomy sample is not suitable.
Presented by W.P.J. Witjes at the 29th Annual European Association of Urology (EAU) Congress - April 11 - 15, 2014 - Stockholmsmässan - Stockholm, Sweden.
EAU Research Foundation, Clinical Research, Arnhem, The Netherlands
Written by Jeffrey J. Tomaszewski, MD, medical writer for UroToday.com