Preliminary Data from Phase 3 VISTA Trial in Bladder Cancer to Be Presented in a Plenary Session at American Urological Association Annual Meeting
Data, as reported in the abstract published online today, are from a
subgroup of the first 75 evaluable carcinoma in situ patients. Within
these patients, preliminary findings show that greater than 95 percent
expressed EpCAM on the surface of tumor cells, the target of Vicinium.
Efficacy data as measured by complete response rates at three-months
will be reported during the plenary session. Vicinium has been
well-tolerated. Treatment-related adverse events (AEs) were reported in
46 percent of patients, the majority of which were Grade 1 or 2. The
most common of these were dysuria (12%), UTI or pollakiuria (10%) and
hematuria (7%), which are often associated with catheter-delivered
treatments into the bladder and bladder cancer itself. As of the
“When treatment with today’s standard of care, BCG, is no longer an
option, the next treatment option is typically removal of the patient’s
bladder, a challenging, life-altering procedure that many patients elect
not to undergo,” said Stephen Hurly, president and chief executive
The company plans to host a conference call in conjunction with the data presentation, with details to follow.
About the VISTA Clinical Trial
The VISTA trial is an open-label, multicenter, single-arm Phase 3 clinical trial evaluating the efficacy and tolerability of Vicinium™ in patients with high-risk non-muscle invasive bladder cancer (NMIBC) that is carcinoma in situ (CIS, cancer found on the inner lining of the bladder that has not spread into muscle or other tissue) or papillary (cancer that has grown from the bladder lining out into the bladder but has not spread into muscle or other tissue), who have been previously treated with bacillus Calmette-Guérin (BCG). The primary endpoint of the trial is the complete response rate in patients with CIS with or without papillary disease and durability of that response. Patients in the study 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 assessing responses and durability of responses at three-months on treatment are expected in mid-2018, with 12-month data anticipated in mid-2019.
Vicinium™, Eleven Biotherapeutics’ lead product candidate, is a next-generation antibody-drug conjugate developed using the company’s proprietary Targeted Protein Therapeutics platform. Vicinium is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A (ETA). Vicinium is constructed with a stable, genetically engineered linker to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical studies conducted by
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