Efficacy & Safety
The Power of ANKTIVA®
ANKTIVA is an interleukin-15 (IL-15) superagonist, which is a type of immunotherapy that causes natural killer and T cells to increase in numbers and become more active without activating immunosuppressive T reg cells.
The efficacy outcome measures for the QUILT 3.032 study were complete response (CR) at any time, defined as negative cystoscopy and urine cytology, and duration of response.
Duration of Response1
0-47+ Months
Meaning some study participants
remained NMIBC-free for almost 4 years
Median duration of response has not
yet been established
In the following data, published in the peer-reviewed journal NEJM Evidence, all participants that met the QUILT 3.032 study protocol criteria are included. This is a broader set of participants than included in the product data sheet, to which the FDA applied additional criteria.
89.2%
(Data from QUILT 3.032 study investigators as published in NEJM Evidence)
94%
(Data from QUILT 3.032 study investigators as published in NEJM Evidence)
Kaplan Meier (KM) Duration of Complete Response3
69%
95% CI (53/80)
66%
95% CI (50/78)
59%
95% CI (41/72)
Learn More about Kaplan Meier Duration of Complete Response3
1. ANKTIVA Package insert. lmmunityBio, Inc.,; 2024. 2. Chamie K, et al. IL-15 Superagonist NAI in BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer. NEJM Evid. 2023 Jan;2(1): EVIDoa2200167. doi: 10.1056/EVIDoa2200167. 3. P. Soon-Shiong, Oral Presentation (MP16-03) AUA May 2024 Presentation. Represents the upper limit of the range of duration of response
Adverse Reactions Occurring in ≥15% of Patients in Cohort A IN QUILT-3.032
| Adverse Reaction | ANKTIVA with BCG1 (n=77) | |
|---|---|---|
| one | two | |
| Dysuria | 32 | 0 |
| Hematuria1 | 32 | 3.4 |
| Urinary | 27 | 0 |
| Micturition Urgency1 | 25 | 0 |
| Urinary Tract Infection1 | 24 | 2.3 |
| Musculoskeletal Pain1 | 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
Efficacy & Safety
A clinical resource highlighting key efficacy and safety information about ANKTIVA (nogapendekin alfa inbakicept-pmln)
ANKTIVA: How to Order
A step-by-step guide on how to order ANKTIVA, including product codes
Patient Stories
Read about patients who participated in the clinical trials for ANKTIVA
Irv’s Journey
He was first diagnosed with bladder cancer in 2016, when on Thanksgiving day, he had several concerning symptoms including blood in his urine. Several tumors on the interior surface of his bladder were removed by his local urologist, who treated him with BCG. Unfortunately, he failed to respond and the tumors came back. He was afraid he was going to lose his bladder.
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
Information for ANKTIVA
ANKTIVA: Efficacy & Safety
A clinical resource highlighting key efficacy and safety information about ANKTIVA (nogapendekin alfa inbakicept-pmln)
ANKTIVA: Mechanism of Action
A description of how BCG and ANKTIVA work together in NMIBC CIS
ANKTIVA: How to Order
A step-by-step guide on how to order ANKTIVA, including product codes
Physicians' Journey
Listen to the physicians' journey with their patients using ANKTIVA.
ANKTIVA is a Novel Treatment for NMIBC CIS Patients Unresponsive to BCG
For more information, please call 1-877-ANKTIVA
