We report long-term follow-up on participants in the QUILT-3.032 study in BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) carcinoma in situ (CIS) +/- papillary disease utilizing nogapendekin alfa inbakicept (NAI) approved by the FDA (ANKTIVA) in combination with BCG.
Participants received 400 mcg NAI in combination with 50 mg BCG via intravesical instillation weekly for six weeks, with optional re-induction if complete response (CR) was not achieved at month 3. Primary endpoints were CR rate at any time; secondary endpoints were duration of CR (DOR), progression-free survival (PFS), overall survival (OS), disease-specific survival (DSS), and time to cystectomy.
The CR rate (n=100) was 71% (95% CI, 61.1, 79.6) with a median DOR of 26.6 months (range, 0.03-53.62). The cystectomy-free rate (CFR) in the 71 responders at 24- and 36-months was 90.3% (95% CI 79.7, 95.6) and 84.2% (95% CI 69.6, 92.1), respectively. DSS was 100% (95% CI 100.0, 100.0) at 12-months, and 98.2% (95% CI 88.2, 99.8) at 36-months. Treatment-related adverse events (TRAE) were largely grade 1 to 2 (61%), with 3% grade 3 and no grade 4 or 5 TRAE observed with this biological combination.
The CR rate and durability of responses that surpass 53 months reveal the efficacy of NAI in combination with BCG for treating BCG-unresponsive NMIBC with CIS +/- Ta/T1 disease. The high CFR of 84% and DSS of 98% at 36-months suggest that NAI plus BCG is a safe and efficacious option for NMIBC with CIS +/- Ta/T1 disease.
The Journal of urology. 2026 Jul 06 [Epub ahead of print]
Sam S Chang, Karim Chamie, Charles A Seabury, Mark L Gonzalgo, Piyush Kumar Agarwal, Jeffrey C Bassett, Marc Bjurlin, Michael L Cher, William Clark, Barrett E Cowan, Richard David, Evan Goldfischer, Khurshid Guru, Mark W Jalkut, Samuel D Kaffenberger, Jed Kaminetsky, Anthony Corcoran, Alec S Koo, Wade J Sexton, Sergei N Tikhonenkov, Mihir S Shah, Edouard J Trabulsi, Andrew F Trainer, Patricia Spilman, Leylah M Drusbosky, Bruce Brown, Megan Huang, Paul Bhar, Lennie Sender, Sandeep Reddy, Patrick Soon-Shiong
Department of Urology, Vanderbilt Ingram Cancer Center, Vanderbilt, University Medical Center, Nashville., Department of Urology, UCLA Medical Center, Los Angeles., Virginia Urology, Richmond, VA., Desai Sethi Urology Institute, University of Miami Miller School of, Medicine, Miami., Department of Surgery, Section of Urology, University of Chicago, Chicago., Hoag Urologic Oncology, Hoag Memorial Presbyterian Hospital, Newport, Beach, CA., Department of Urology, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC., Department of Urology, Wayne State University, Detroit., Alaska Urological Institute, Soldotna, AK., Urology Associates, Englewood, CO., Genesis Healthcare Partners, Greater Los Angeles Division, Sherman, Oaks, CA., Premier Medical Group, Poughkeepsie, NY., Roswell Park Comprehensive Cancer Center, Buffalo, NY., Associated Urologists of North Carolina, Raleigh, NC., Department of Urology, University of Michigan, Ann Arbor, MI., University Urology, New York., NYU Winthrop Hospital, Garden City, NY., Genesis Healthcare Partners, Torrance, CA., Moffitt Cancer Center, Tampa, FL., University of Hawaii Cancer Center, Honolulu., Department of Urology, Sidney Kimmel Medical College at Thomas, Jefferson University, Philadelphia., Jefferson Einstein Medical Center, Philadelphia, PA., Adult and Pediatric Urology, Omaha, NE., ImmunityBio, Culver City, CA.