https://sesenbio.com/wp-content/uploads/2019/01/BLADDR_Congress_2018_Posterl.pdf
SUMMARY AND CONCLUSIONS
1. 3-month data from the VISTA Trial demonstrate 42% CR rate in subjects with CIS recurring within 12 months of last BCG treatment a. Confirmation of prior proof-of-concept data. b. Recurrence within 12 months of BCG is consistent with US FDA guidelines c. The novel mechanism of Vicinium coupled with the promising clinical benefit may provide an important alternative to existing therapies, including radical cystectomy.
2. Initial data in subjects with recurrent papillary-only NMIBC demonstrate 68% recurrence-free rate at 3 months.
3. The safety profile of Vicinium remains tolerable and manageable.
4. EpCAM, the molecular target of Vicinium, is nearly ubiquitously expressed in high-grade NMIBC. Additional biomarker analysis is in progress. 5. Vicinium has a familiar and convenient administration schedule similar to BCG-like instillation.