Sam Chang, MD, shares updated data on nogapendekin alfa inbakicept in NMIBC

Nogapendekin alfa inbakicept-pmln (NAI; Anktiva) demonstrated high complete response (CR) and avoidance of cystectomy rates in patients with high-risk BCG-unresponsive bladder carcinoma in situ (CIS), according to updated data from the phase 2/3 QUILT-3.032 trial (NCT03022825) presented at the 2025 American Urological Association Annual Meeting in Las Vegas, Nevada.

In an interview with Urology Times®, presenting author Sam S. Chang, MD, MBA, discusses these findings in depth.

“The abstract that was presented at AUA 2025 focused on the longest follow-up to date on any of these newer medications or intravesical therapies for non–muscle invasive bladder cancer that is not responsive to BCG,” he explained. “The key findings were, number 1, a verification of previous findings. What I mean by that is the complete response rates remain quite high.”

Specifically, in cohort A, which included 100 patients with BCG-unresponsive NMIBC with CIS with or without papillary disease, the CR rate was 71% (95% CI: 61.1-79.6). The duration of response ranged up to more than 53 months. Data from the study also showed that at 36 months, 84% of patients had not undergone cystectomy.
Chang noted, “So, we can tell folks that you only have about a 15% chance of requiring bladder removal if you're treated with NAI.”

Chang is chief of the division of urologic oncology and the chief surgical officer at the Vanderbilt Ingram Cancer Center in Nashville, Tennessee.

In cohort B of the study, which included 80 patients with BCG-unresponsive NMIBC papillary disease without CIS, the disease-free survival was 58% (95% CI: 46.6-68.2) at 12 months and 52% (95% CI: 40.3-62.7) at 24 months. The median disease-free survival was 25.3 months (95% CI: 9.8-40.1).

Further, the cystectomy-free rate was 92% at 12 months and 82% at 36 months.

NAI is currently approved in the US for patients with BCG-unresponsive NMIBC with CIS with or without papillary disease.