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Association details:
Biomarker:No biomarker
Cancer:Bladder Cancer
Drug:Anktiva (nogapendekin alfa inbakicept-pmln) (IL-15 superagonist)
Direction:Sensitive
Evidence:
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

FINAL CLINICAL RESULTS OF PIVOTAL TRIAL OF IL-15R?FC SUPERAGONIST N-803 WITH BCG IN BCG-UNRESPONSIVE NON-MUSCLE INVASIVE BLADDER CANCER (NMIBC) CIS AND PAPILLARY COHORTS

Published date:
04/09/2022
Excerpt:
CIS patients have a CR rate of 71% (59/83), with a mediation duration of CR of 24.1 months in responders; 91% avoided cystectomy and 96% 24 month bladder cancer specific progression free survival (defined as progression to MIBC). Papillary patients have a 57% 12 month DFS rate, 48% 24 month DFS rate, and 95% avoided cystectomy. In 160 patients with BCG-unresponsive NMIBC, there is a 99% bladder cancer specific overall survival at 2 years. In CIS patients 71% CR rate with 24.1 months median duration of response and 96% absence of progression to MIBC at 24 months. 53% DFS rate at 18 months in Papillary disease, N-803+BCG efficacy and safety profile exceeds other available intravesical and systemic options.
DOI:
https://doi.org/10.1097/JU.0000000000002671.01
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Title:

Positive efficacy and safety phase 3 results in both CIS and papillary cohorts BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC) after IL-15RaFc superagonist N-803 (Anktiva) and BCG infusion.

Published date:
02/14/2022
Excerpt:
N-803 and BCG was safe and well tolerated with zero percent treatment related or immune related SAEs. The primary end points of both CIS and Papillary disease were met with CR rate of 72% and 12 month Disease free rate of 57% respectively. Durable responses were noted in both cohorts and the therapy resulted in significant avoidance of cystectomy with a cystectomy free rate of 92% and a 24 month cancer specific survival of 99.5% Given the observed strong efficacy and favorable AE profile and mode of administration, N-803 represents a significant advance in the treatment option compared to existing therapies for BCG unresponsive CIS and Papillary NMIBC.
DOI:
10.1200/JCO.2022.40.6_suppl.431
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Title:

ImmunityBio Granted FDA Breakthrough Therapy Designation for N-803 IL-15 Superagonist in Non-Muscle Invasive Bladder Cancer

Published date:
12/04/2019
Excerpt:
ImmunityBio...has received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) for its interleukin-15 (IL-15) agonist complex, N-803, in combination with Bacillus Calmette-Guerin (BCG), for the treatment of patients with BCG-unresponsive non-muscle invasive bladder carcinoma in situ (CIS).
Secondary therapy:
BCG