Christopher Pieczonka, MD, discusses early data on NAI plus BCG in BCG-naïve NMIBC

In this interview, Christopher M. Pieczonka, MD, discusses the design and interim findings from the phase 2 QUILT 2.005 trial (NCT02138734), evaluating nogapendekin alfa inbakicept-pmln (NAI; Anktiva) plus BCG in patients with BCG-naïve non–muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. Pieczonka is the chief executive officer and director of clinical research at Associated Medical Professionals in Syracuse, New York.

The open-label, multi-center QUILT 2.005 trial is a randomized, open-label study comparing the combination of NAI plus BCG against BCG alone, which remains the standard of care in this setting. The study recently completed accrual in early March 2026. An interim analysis of the data was conducted at the request of the FDA in order to determine if the study was trending in a favorable direction.

Preliminary results from the trial suggest a potential efficacy advantage for the combination approach. Among patients evaluable at 9 months, the complete response rate was 84% in the NAI plus BCG arm compared with 52% for BCG alone, a statistically significant difference (P = .0455). At 6 months, response rates were 85% vs 57%, respectively, although this comparison did not reach statistical significance (P = .0536).¹

According to ImmunityBio, no significant safety concerns have been reported with the combination.

The company expects additional data from the trial to be available in Q4 of 2026. They also plan to submit a biologics license application to the FDA for this indication by Q4 of 2026.

REFERENCE

1. ImmunityBio completes enrollment in pivotal randomized trial evaluating ANKTIVA® plus BCG versus BCG alone in BCG-naïve non-muscle invasive bladder cancer carcinoma in situ. News release. ImmunityBio. February 26, 2026. Accessed March 19, 2026. https://www.businesswire.com/news/home/20260226601563/en/ImmunityBio-Completes-Enrollment-in-Pivotal-Randomized-Trial-Evaluating-ANKTIVA-Plus-BCG-Versus-BCG-Alone-in-BCG-Nave-Non-Muscle-Invasive-Bladder-Cancer-Carcinoma-In-Situ