Drug updated on 12/11/2024
Dosage Form | Solution (intravesical; 400 mcg/0.4 mL) |
Drug Class | Interleukin-15 (IL-15) receptor agonists |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated with Bacillus Calmette-Gurin (BCG) for the treatment of adult patients with BCGunresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.
Latest News
Summary
- This summary is based on the review of one randomized controlled trial. [1]
- In the QUantum Immuno-oncology Lifelong Trial (QUILT)-3.032 study, N-803 (nogapendekin alfa inbakicept) combined with Bacillus Calmette-Guérin (BCG) induced durable complete responses in patients with BCG-unresponsive nonmuscle-invasive bladder cancer (NMIBC).
- Patient-reported outcomes, including physical function (PF) and global health (GH) scores, remained stable from baseline through the 24-month follow-up for both Cohort A (patients with carcinoma in situ with or without Ta/T1 disease) and Cohort B (patients with high-grade Ta/T1 papillary disease).
- Subgroup analysis revealed that in Cohort A, patients with a complete response had higher PF scores at month 6 (P = .0659), while those with more than three prior bladder tumor resections showed lower GH scores at month 12 (P = .0729). In Cohort B, baseline disease type was linked to PF scores (P = .0738), and race significantly influenced GH scores at month 6 (P = .0478).
- There is no safety information available in the reviewed studies.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Anktiva (nogapendekin alfa inbakicept-pmln) Prescribing Information. | 2024 | ImmunityBio, Inc., Culver City, CA |
Randomized Controlled Trials
Document Title | Sex Distribution | Year | Source |
---|---|---|---|
Quality of Life in the Phase 2/3 Trial of N-803 Plus Bacillus Calmette-Guerin in Bacillus Calmette-Guerin‒Unresponsive Nonmuscle-Invasive Bladder Cancer | 167Subjects F: 19% M: 81% | 2024 | Urology Practice |
Sex Distribution:
F:19%
M:81%
167Subjects
Year:
2024
Source:Urology Practice