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QUILT-3.032

IL-15 Superagonist NAI in BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer

Phase 2/3NCT03022825

Population
Adults with BCG-unresponsive non-muscle-invasive bladder cancer: carcinoma in situ with or without papillary disease (cohorts A and C) or high-grade Ta/T1 papillary disease (cohort B).
Design
Open-label, multicentre study with three cohorts: A (BCG-unresponsive carcinoma in situ with or without Ta/T1 papillary disease; intravesical NAI plus BCG), B (BCG-unresponsive high-grade Ta/T1 papillary disease; NAI plus BCG) and C (carcinoma in situ; NAI alone). Primary endpoints: incidence of complete response at the 3- or 6-month assessment (cohorts A and C) and disease-free survival rate at 12 months (cohort B). Durability, cystectomy avoidance, progression-free survival, disease-specific survival and overall survival were secondary endpoints for cohort A. Results for cohort C are not recorded here. The registry title names the study QUILT-3.032; the registry lists enrolment 190.
Primary endpoint
Complete response in carcinoma in situ, DFS
Arms
  • Cohort A: NAI plus BCG, carcinoma in situ (experimental, n = 82): Intravesical NAI plus BCG
  • Cohort B: NAI plus BCG, papillary disease (experimental, n = 72): Intravesical NAI plus BCG
  • Cohort C: NAI alone, carcinoma in situ (experimental): Intravesical NAI alone
People
Chamie K
Show the numbers
Results reported for QUILT-3.032
EndpointAnalysisCohort A: NAI plus BCG, carcinoma in situ / Cohort B: NAI plus BCG, papillary disease / Cohort C: NAI alone, carcinoma in situControlEffect
Complete response in carcinoma in situCohort A: 82 patients with BCG-unresponsive carcinoma in situ with or without Ta/T1 papillary disease; not described as intention-to-treatComplete response at the 3- or 6-month assessment visitprimarymedian follow-up 23.9 monthsChamie 202371% (59.6–80.3%)—58 of 82 patients.
DORCohort A patients with a complete responseprimarymedian follow-up 23.9 monthsChamie 2023median 26.6 months—95% confidence interval 9.9 months to not reached (upper bound not stored as a number).
Cystectomy avoidanceCohort A patients with a complete responseprimaryChamie 202389.2% at 2 y—Kaplan-Meier estimate among patients with a complete response; no confidence interval in the abstract.
Bladder cancer-specific survivalCohort A patients with a complete responseDisease-specific survival as labelled in the abstract (the conclusion calls it bladder cancer-specific survival)primaryChamie 2023100% at 2 y—Kaplan-Meier estimate among patients with a complete response; no confidence interval in the abstract.
DFSCohort B: 72 patients with BCG-unresponsive high-grade Ta/T1 papillary diseaseprimaryChamie 2023median 19.3 months; 55.4% at 12 mo (42.0–66.8%)—Median DFS 95% confidence interval 7.4 months to not reached (upper bound not stored as a number).
Results reported for QUILT-3.032
EndpointAnalysisCohort A: NAI plus BCG, carcinoma in situ / Cohort B: NAI plus BCG, papillary disease / Cohort C: NAI alone, carcinoma in situControlEffect
Complete response in carcinoma in situCohort A: 82 patients with BCG-unresponsive carcinoma in situ with or without Ta/T1 papillary disease; not described as intention-to-treatComplete response at the 3- or 6-month assessment visitprimarymedian follow-up 23.9 monthsChamie 202371% (59.6–80.3%)—58 of 82 patients.
DORCohort A patients with a complete responseprimarymedian follow-up 23.9 monthsChamie 2023median 26.6 months—95% confidence interval 9.9 months to not reached (upper bound not stored as a number).
Cystectomy avoidanceCohort A patients with a complete responseprimaryChamie 202389.2% at 2 y—Kaplan-Meier estimate among patients with a complete response; no confidence interval in the abstract.
Bladder cancer-specific survivalCohort A patients with a complete responseDisease-specific survival as labelled in the abstract (the conclusion calls it bladder cancer-specific survival)primaryChamie 2023100% at 2 y—Kaplan-Meier estimate among patients with a complete response; no confidence interval in the abstract.
DFSCohort B: 72 patients with BCG-unresponsive high-grade Ta/T1 papillary diseaseprimaryChamie 2023median 19.3 months; 55.4% at 12 mo (42.0–66.8%)—Median DFS 95% confidence interval 7.4 months to not reached (upper bound not stored as a number).
Illustrative — modelled from reported values, not trial data. DOR, primary.
0%25%50%75%100%0102030405060Months (modelled)
  • Cohort A: NAI plus BCG, carcinoma in situ (experimental)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsCohort A: NAI plus BCG, carcinoma in situ
0100.0%
1764.2%
3342.3%
5027.2%
6717.4%
Illustrative — modelled from reported values, not trial data. DFS, primary.
0%25%50%75%100%010203040Months (modelled)
  • Cohort B: NAI plus BCG, papillary disease (experimental)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsCohort B: NAI plus BCG, papillary disease
0100.0%
1265.0%
2442.2%
3627.4%
4817.8%
Primary publication: Chamie K, Chang SS, Kramolowsky E, Gonzalgo ML, Agarwal PK, Bassett JC, et al. IL-15 Superagonist NAI in BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer. NEJM Evid. 2023;2(1):EVIDoa2200167. PubMedDOI

Appears in

Sources

  1. Chamie K, Chang SS, Kramolowsky E, Gonzalgo ML, Agarwal PK, Bassett JC, et al. IL-15 Superagonist NAI in BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer. NEJM Evid. 2023;2(1):EVIDoa2200167.

    PubMedDOI