ImmunityBio Completes Phase 2 Clinical Study Enrollment To Evaluate ANKTIVA Plus Bacillus Calmette-Guérin

ImmunityBio ((IBRX), a commercial-stage immunotherapy company, today announced completion of enrollment in its Phase 2 clinical trial evaluating ANKTIVA® (nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) versus BCG alone in patients with BCG-naïve non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS), with or without papillary tumors.

The QUILT 2.005 trial (NCT02138734), which completed enrollment ahead of schedule, includes 366 patients randomized to receive either BCG alone, the current standard-of-care for NMIBC CIS, or ANKTIVA in combination with BCG. An interim analysis requested by the U.S. Food and Drug Administration (FDA) demonstrated that treatment with ANKTIVA plus BCG resulted in a statistically significant improvement in the duration of complete response compared with BCG alone, with no significant safety concerns reported.

The interim analysis demonstrated that at six months, 85% of patients receiving ANKTIVA plus BCG maintained a complete response, compared with 57% of patients treated with BCG alone. At nine months, 84% of subjects in the ANKTIVA plus BCG arm maintained a complete response, compared with 52% of patients in the BCG-alone arm. Despite the limited sample size of the interim analysis, the difference in duration of complete response at nine months reached statistical significance (p=0.0455).