Nogapendekin alfa inbakicept-pmln

(Anktiva®)

Nogapendekin alfa inbakicept-pmln

Drug updated on 10/17/2024

Dosage FormSolution (intravesical; 400 mcg/0.4 mL)
Drug ClassInterleukin-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.

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Summary
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  • This summary is based on the review of one randomized controlled trial(s). [1]
  • In the QUILT (QUantum Immuno-oncology Lifelong Trial)-3.032 study, N-803 (nogapendekin alfa inbakicept) combined with BCG (Bacillus Calmette-Guérin) 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 TitleYearSource
Anktiva (nogapendekin alfa inbakicept-pmln) Prescribing Information.2024ImmunityBio, Inc., Culver City, CA

Randomized Controlled Trials