ImmunityBio’s ANKTIVA Plus BCG Demonstrates Durable Survival And Bladder Preservation In NMIBC

ImmunityBio, Inc. announced that treatment with ANKTIVA® (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin (BCG) demonstrated durable clinical benefit in patients with BCG-unresponsive high-grade papillary-only non-muscle invasive bladder cancer (NMIBC). Published in the January 2026 print edition of The Journal of Urology, the data showed sustained efficacy at 12, 24 and 36 months, including strong disease-free survival, progression-free survival, and high rates of bladder preservation, with a safety profile comparable to BCG alone.

“Patients with BCG-unresponsive papillary-only non-muscle invasive bladder cancer have few treatment options, with cystectomy being considered the definitive treatment,” said lead author Sam S. Chang, M.D., Professor of Urology and Chief Surgical Officer of the Vanderbilt Ingram Cancer Center. “Prolongation of progression-free survival, disease-specific free survival and avoidance of bladder removal are clinically meaningful goals of next-generation chemotherapy-free immunotherapy. Our findings provide evidence that ANKTIVA plus BCG would offer a novel and efficacious treatment option for these patients.”

Results from Cohort B of the Phase 2/3 QUILT-3.032 study (n=80) showed a disease-free survival rate of 58.2% at 12 months, declining to 52.1% at 24 months and 38.2% at 36 months. Disease-specific survival remained high, reaching 98.7% at one year and 96.0% at three years, with median DSS not yet reached. Progression-free survival rates were 94.9% at 12 months and 83.1% at 36 months, highlighting durable long-term disease control.

“The 12- and 36-month rates for disease-free, progression-free, and disease-specific survival seen in this study are higher than those reported for other investigational therapies in this patient population,” added Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. “Together with the high rates of cystectomy avoidance, with the median to cystectomy not yet reached, and the 96% bladder cancer-specific survival at three years, also with median not yet reached, demonstrates the effectiveness of ANKTIVA in enhancing the immune response. These finding point to a potential paradigm change in the treatment of BCG-unresponsive high-grade papillary-only NMIBC.”

Importantly, treatment with ANKTIVA plus BCG enabled bladder preservation in the majority of patients. Cystectomy avoidance rates were 92.2% at 12 months and 81.8% at 36 months, underscoring the therapy’s potential to delay or eliminate the need for radical surgery. The safety analysis across cohorts A and B (n=180) showed predominantly mild to moderate treatment-related adverse events, with grade 3 events occurring in just 3% of patients and no grade 4 or 5 events reported.

“The evidence that CIS and papillary disease are clonally linked, combined with the QUILT-3.032 findings showing long-term cystectomy avoidance, sustained avoidance of progression to muscle-invasive disease, and 96% bladder cancer-specific survival at three years, supports the consideration that ANKTIVA plus BCG addresses the unmet need for patients with papillary disease alone who face the prospect of total radical cystectomy following failure of BCG therapy,” said Dr. Soon-Shiong.

ANKTIVA plus BCG is already approved in the U.S., U.K. and under conditional authorization in the European Union for patients with BCG-unresponsive NMIBC with carcinoma in situ, with or without papillary tumors. These new data extend the clinical evidence supporting its use in papillary-only disease, addressing a major unmet need in a population where effective bladder-sparing therapies remain limited.