ImmunityBio Expects To Submit US Application For VesAnktiva In Bladder Cancer This Month

ImmunityBio Inc IBRX achieved a significant milestone with over 80 subjects in the QUILT-3.032 study completing at least 12 months of follow-up as of January 14. 

• QUILT-3.032 is evaluating VesAnktiva plus BCG in subjects with BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ (NMIBC CIS).
• All data have been locked and analyzed. 
• The results continue to demonstrate a sustained clinically meaningful benefit.
• Also See: ImmunityBio's Ankitva Shows 100% Survival At Two Years In Bladder Cancer Setting.
• The U.S. marketing application has been compiled and, following final quality review, is expected to be submitted to the FDA this month. 
• The FDA granted Fast Track Designation to the pivotal trial based on Phase 1 data. 
• "With 71% of the participants in this study having a complete response and a median duration of response of 26.6 months, we believe we have a clinically meaningful therapeutic alternative for patients suffering from NMIBC in which the only option remaining is total cystectomy," said Patrick Soon-Shiong, Executive Chairman and Global Chief Scientific and Medical Officer
• Price Action: IBRX shares closed 4.13% higher at $6.05 during after-hours trading on Friday.