ImmunityBio Reports Phase 3 Data Showing 84% Cystectomy Avoidance at Three Years and Complete Responses Beyond 53 Months with ANKTIVA® Plus BCG in BCG-Unresponsive NMIBC With CIS, With or Without Papillary Tumors
ImmunityBio published long-term data from the Phase 2/3 QUILT-3.032 study (N=100) in the Journal of Urology for ANKTIVA plus BCG in BCG-unresponsive NMIBC with CIS. The data showed a 71% complete response rate, a median CR duration of 26.6 months with responses beyond 53 months, and 84% cystectomy-free survival at 36 months, with 98.2% disease-specific survival at three years. Safety remained favorable, with only Grade 1-2 events for most patients, 4% Grade 3 treatment-related adverse events, and no Grade 4 or 5 events reported.
Key figures
- Drug Name
- ANKTIVA (nogapendekin alfa inbakicept-pmln)
- Phase Of Trial
- Phase 2/3
- Study
- QUILT-3.032
- Patients
- 100
- Grade4 5 trae
- none reported
- Grade3 trae rate
- 4%
- Complete response rate
- 71%
- Cr rate bcg refractory
- 66%
- Cr duration beyond months
- 53
- Median duration of cr months
- 26.6
- Cystectomy free survival 36mo
- 84%
- Disease specific survival 3yr
- 98.2%
- Progression free survival 3yr
- 80.9%
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