Nogapendekin Alfa Combo Earns Saudi FDA Accelerated Approval in NMIBC Type

Nogapendekin alfa inbakicept-pmln (Anktiva) plus BCG therapy has been granted accelerated approval by the Saudi Food and Drug Authority as a treatment for patients with BCG-unresponsive non–muscle-invasive bladder cancer (NMIBC) with carcinoma in situ, with or without papillary disease, according to a news release from the developer, ImmunityBio.¹

Data from the phase 2/3 QUILT-3.032 trial (NCT03022825) supported the accelerated approval of the nogapendekin alfa regimen. Findings presented at the American Urological Association 2025 Annual Meeting revealed that among patients with carcinoma in situ (n = 100), the complete response (CR) rate was 71% (95% CI, 61.1%-79.6%), with a median duration of CR of more than 53 months among evaluable responders (n = 71).² The cystectomy avoidance rate at 12, 24, and 36 months was 96%, 90%, and 84%, respectively. Additionally, for these patients, the 36-month disease-specific survival (DSS) rate was 100% at 12 months, and 99% up to 36 months.

“We are pleased to bring [nogapendekin alfa inbakicept] to patients [in Saudi Arabia] with NMIBC, who otherwise have no viable options but life-altering surgery,” Rich Adcock, president and chief executive officer at ImmunityBio, Inc, said in the news release.¹ “At ImmunityBio, we are committed to using our innovative science to improve the health of people around the world, and we continue investing in research and clinical trials that we believe are essential to fulfilling that mission.”

Investigators in the open-label, multicenter study enrolled patients with histologically confirmed BCG-unresponsive carcinoma in situ with or without papillary disease and assigned them to 3 cohorts: cohorts A and C, which included those with carcinoma in situ; and cohort B, which included those who did not have carcinoma in situ.³ Patients in cohorts A and B were treated with 400 μg of intravesical nogapendekin alfa inbakicept with intravesical BCG at 50 mg; those in cohort C received 400 μg of intravesical nogapendekin alfa inbakicept alone.

The primary end point of cohorts A and C was the 3- and 6-month CR incidence. The primary end point of cohort B was disease-free survival at 12 months. Secondary end points included response durability, cystectomy avoidance rate, progression-free survival, DSS, and overall survival.

Safety findings revealed that intravesical administration of nogapendekin alfa inbakicept plus BCG was well-tolerated in the carcinoma in situ population. A total of 3% of patients treated with the combination in cohorts A and B experienced grade 3 treatment-related adverse effects (TRAEs), with no grade 4 or 5 events reported. The majority of TRAEs were grade 1 or 2 and were related to intravesical instillation.

Single instances of grade 3 dysuria, pollakiuria, hematuria, urinary tract infection, and arthralgia were observed. Two patients experienced myalgia across both cohorts.

“The incidence of bladder and other cancers in the Middle East and North Africa is large and growing, demonstrating a significant unmet need for the kind of innovative treatments ImmunityBio is developing,” Adcock concluded.¹ “We are pursuing approvals across the region to fill that need, as well as investing in a regional office in Saudi Arabia in order to support our expansion into these growing markets.”

The developers have begun the phase 1b/2b QUILT-2.005 trial (NCT02138734) evaluating the same combination vs BCG alone among BCG-naive patients, with the study population currently exceeding enrollment projections. Completion of enrollment is planned for the second quarter of 2026, and the developers plan to submit a biologics license application by the end of 2026.

References

1. Saudi FDA grants accelerated approval to ImmunityBio’s Anktiva for non-muscle invasive bladder cancer with carcinoma in-situ. News release. ImmunityBio. January 14, 2026. Accessed January 14, 2026. https://tinyurl.com/4jaehcsf
2. AUA 2025: an update on QUILT-3.032: complete responses to N-803 plus BCG therapy in BCG-unresponsive bladder carcinoma in situ (CIS) with or without Ta/T1 papillary disease. News release. UroToday. Accessed January 14, 2026. https://tinyurl.com/yx284h4u
3. Chamie K, Chang SS, Kramolowsky E, et al. IL-15 superagonist NAI in BCG-unresponsive non–muscle-invasive bladder cancer. NEJM Evid. 2023;2(1):EVIDoa2200167. doi:10.1056/EVIDoa2200167