QUILT 3.032
An IL-15 booster given with BCG produced complete responses in about 70% of patients with BCG-unresponsive carcinoma in situ and kept most bladders intact for years.
CR 71% in CIS cohort; median duration of CR ~26 months; bladder preservation >80% at 3 years in responders (company 5-year update). FDA approval 22 April 2024 after a 2023 complete response letter over manufacturing.
Setting
BCG-unresponsive NMIBC with CIS: nogapendekin alfa inbakicept (N-803) + BCG, single arm
Phase
Phase 2
Sponsor
ImmunityBio
Registry
Headline result
CR 71%.
Reported
2022
Replication
Single-arm; QUILT 2.005 (BCG-naive) and BCG-unresponsive papillary cohorts extend the evidence.
In plain words
What these results mean for people, not percentages
Complete response rate (CIS)primaryresponse endpoint
- 71 out of 100 people had their tumour shrink with N-803 + BCG.
- There was no comparison group, so this number cannot tell you how much of the effect is due to the treatment.
- A response rate counts how many people had their tumours shrink by a set amount; shrinking is encouraging but does not by itself show that people live longer or feel better.
- These results apply to the people the trial enrolled: BCG-unresponsive NMIBC with CIS: nogapendekin alfa inbakicept (N-803) + BCG, single arm. People in a different situation may not see the same effect.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
Complete response rate (CIS)primary
N-803 + BCG71 of 100
n = 77
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Complete response rate (CIS)primary | N-803 + BCG | 77 | 71% | — | — | — |
Replication
Single-arm; QUILT 2.005 (BCG-naive) and BCG-unresponsive papillary cohorts extend the evidence.Pages like this
not linked directly; found by shared links- CompanyImmunityBio
Shares Nogapendekin alfa inbakicept, Bladder & urothelial cancer.
- TrialSunRISe-1
- PairingDurvalumab + BCG in BCG-naive high-risk NMIBC
- TrialBOND-003
- TechnologyIntravesical therapy (BCG, chemotherapy, devices, gene and viral therapy)
Shares Nogapendekin alfa inbakicept, Intravesical BCG, BCG-unresponsive, Bladder & urothelial cancer.
- TrialPOTOMAC
- ProductGemcitabine intravesical system (TAR-200)
- IdeaEngineered bacteria that live in tumours and manufacture drugs there