Eleven Biotherapeutics has concluded enrolment in the VISTA trial, a Phase III clinical study designed to evaluate the efficacy and tolerability of Vicinium in patients with high-risk non-muscle invasive bladder cancer (NMIBC).
The study’s primary endpoint is the complete response rate in patients with carcinoma in-situ (CIS) with or without papillary disease.
The trial has enrolled NMIBC patients who have been previously treated with bacillus Calmette-Guérin (BCG). Patients will receive locally administered Vicinium twice a week for six weeks, followed by once-weekly treatment for another six weeks, then treatment every other week for up to two years.
Topline data evaluating responses and durability of responses at three-months on treatment are scheduled to be available mid-2018, with 12-month data expected next year.
VISTA trial investigator Donald Lamm said: “Bladder cancer is one of the most prevalent cancers in the US, yet there has been limited development of new therapeutic options for patients in more than 30 years.
“Today’s standard-of-care for NMIBC provides initial responses in many patients; however, after BCG is no longer effective, there are no meaningful FDA-approved options except surgical removal of the bladder in high-risk patients.
“I am encouraged by the data demonstrated with Vicinium in prior trials and its potential to offer my patients an alternative to radical cystectomy.”
Vicinium is a next-generation antibody-drug conjugate (ADC) and features a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumour cells to deliver a potent protein payload, Pseudomonas Exotoxin A (ETA).
The VISTA trial is expected to support the registration of Vicinium for the treatment of NMIBC in patients who have previously received two courses of BCG and whose disease is now BCG-unresponsive.