The Tri-Offense: Activating Your Immune Response
In the pivotal clinical trial, treatment of participants with BCG-unresponsive NMIBC with CIS with or without papillary disease with Anktiva plus BCG was found to have complete and durable responses.1
QUILT-3.032 Study
58% (n=28) ≥12 months; 40% (n=19) ≥24 months; range: 0.0–47.0+ months.1
+ Denotes an ongoing response.
Full Enrollment Follow-up
Some patients remained NMIBC-free for over 4 years.2
+ Denotes an ongoing response.
QUILT-3.032 is a multicenter, single-arm study in adults with BCG-unresponsive high-risk NMIBC with CIS ± Ta/T1 papillary disease. Efficacy was evaluated in 77 adults (label), with updated follow-up in 100 patients. Patients received nogapendekin alfa inbakicept-pmln 400 mcg plus BCG weekly for 6 weeks, with re-induction permitted at month 3. The primary endpoint was complete response.1,2
References: 1. Anktiva (nogapendekin alfa inbakicept-pmln) prescribing information. ImmunityBio, 2024. 2. Chang, S. (2025, April 26-29). An Update on QUILT-3.032: Durable Complete Responses to NAI (ANKTIVA) Plus BCG Therapy in BCG-Unresponsive CIS With or Without Ta/T1 Papillary Disease and in Papillary Disease without CIS. [Conference Presentation]. AUA2025, Las Vegas, Nevada, United States.
Adverse Reactions Occurring in ≥15% of Patients in Cohort A in QUILT-3.032
| Adverse Reaction | Anktiva with BCG1 (n=88) | |
|---|---|---|
| All Grades, % | Grades 3 or 4, % | |
| Dysuria | 32 | 0 |
| Hematuriaa | 32 | 3.4 |
| Urinary Frequency | 27 | 0 |
| Micturition Urgencya | 25 | 0 |
| Urinary Tract Infectiona | 24 | 2.3 |
| Musculoskeletal Paina | 17 | 2.3 |
| Chills | 15 | 0 |
| Pyrexia | 15 | 0 |
Clinically relevant adverse reactions in <15% of patients who received Anktiva with BCG included fatigue (14%), nausea (14%), bladder irritation (11%), diarrhea (9%), and nocturia (7%).
Efficacy Results in QUILT-3.032
| Anktiva with BCG1 (n=77) | |
|---|---|
| Complete Response Rate (95% CI) | 62% (51, 73) |
| Duration of Responsea | |
| Range in months | 0.0, 47.0+ |
| % (n) with duration ≥ 12 months | 58% (28) |
| % (n) with duration ≥ 24 months | 40% (19) |
a. Based on 48 patients that achieved a complete response at any time; reflects period from the time complete response was achieved
Getting Started With Anktiva
See how Anktiva works with BCG in the Tri-offense and what to expect before and after treatment
Patient Story
A Patient Like You
Read about a patient who participated in the clinical trials for Anktiva
Wayne’s Journey
Wayne has lived a rich life with his wife, two daughters, and three grandchildren. He describes himself as someone who “just likes people.” When he was first told, “you might have a tumor in your bladder,” he became very concerned, especially when he learned his first treatment with BCG wasn’t working. Wayne feels lucky that a friend told him about a clinical trial for patients like himself who were not cured by BCG alone.
Anktiva Resources
Learn more about the clinical story of Anktiva
Future Oncology
A plain language review of the published findings on the Phase 1b BCG-naïve and Phase 2/3 BCG-unresponsive studies (QUILT 3.032).
When BCG Alone Isn’t Enough,
Bring On the Tri-Offense With Anktiva.
For more information, please call 1-877-ANKTIVA.
