Reaffirming our Commitment to Advertising Compliance: Read our Corrective Communication here.

Patients & Caregivers Website Healthcare Professionals Website

Efficacy & Safety

The Power of the Tri-Offense

Anktiva is an interleukin-15 (IL-15) receptor agonist, 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.1

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.1

 

 

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

QUILT-3.032 Study

Primary Endpoint
Infographic on black background showing a partial blue-and-gray circular gauge with large purple text “62% CR” and explanatory text below: “of study participants achieved a complete response, meaning their cancer was eliminated. (n=77; 95% CI: 51-73)¹ Biopsy confirmed.”

Full Enrollment Follow-up

Primary Endpoint
Infographic on black background displaying a partial blue-and-gray circular gauge with large purple text “71% CR” and supporting text: “of study participants had a complete response (n=100; 95% CI: 61-80).² Biopsy confirmed.”

Patients who achieved a CR were followed over time to assess how long the response lasted.

FDA Label Population Duration of Response1

Infographic of three connected circles with calendar icons showing 12 month 58%, 24 month 40%, and 36 month NR, in a gradient from light blue to purple

Full Enrollment Follow-up Duration of Response (Kaplan-Meier estimate)2

Infographic of three connected circles with calendar icons showing 12 month 64%, 24 month 52%, and 36 month 44%, in a gradient from light blue to purple

Among responders, the median duration of response was 26.6 months (range: 0-54).2

NR, not yet reached.

Learn More about Kaplan Meier Duration of Complete Response1,2

References: 1. Anktiva (nogapendekin alfa inbakicept-pmln) Prescribing Information. ImmunityBio, 2024. 2. Chang S, et al. J Urol. 2026; Accepted for publication; in press.

Adverse Reactions Occurring in ≥15% of Patients in Cohort A in QUILT-3.0321

Adverse Reactions Anktiva with BCG (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
a. Includes other related terms

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%). 

Adverse Reactions Occurring in ≥15% of Patients in Cohort A in the Full Enrollment Follow-up2

Adverse Reactions Anktiva with BCG (n=100)
All Grades 1-2, % Grades 3 or 4, %
Dysuria 26 0
Pollakiuria 23 0
Hematuria 19 1

Clinically relevant adverse reactions (all grades) in <15% of patients who received Anktiva with BCG included micturition urgency (14%), fatigue (12%), urinary tract infection (8%), and bladder spasm (7%).

Medical efficacy and safety infographic for Anktiva (nogapendekin alfa inbakicept-pmln) highlighting complete response rates of 62% (FDA label, n=77) and 71% (full follow-up, n=100), with durable responses up to 47+ and 53+ months, biopsy-confirmed data, study details, indication for BCG-unresponsive NMIBC with CIS, and safety information on dark purple and white background.

Efficacy & Safety

Anktiva is the only IL-15 receptor agonist that re-engages
the immune system in patients with BCG-unresponsive
NMIBC with CIS with or without papillary tumors

Download PDF

Anktiva Resources

DATASHEET

Mechanism of Action

A description of how BCG and Anktiva work together in NMIBC CIS

Download PDF

DATASHEET

How to Order

A step-by-step guide on how to order Anktiva, including product codes

Download PDF

See All Resources
Indication and Important Safety Information

INDICATION AND USAGE

ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

WARNINGS AND PRECAUTIONS

Risk of Metastatic Bladder Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the development of muscle invasive or metastatic bladder cancer, which can be lethal. If patients with CIS do not have a complete response to treatment after a second induction course of ANKTIVA with BCG, reconsider cystectomy.

DOSAGE AND ADMINISTRATION

For lntravesical Use Only. Do not administer by subcutaneous or intravenous routes. Instill intravesically only after dilution. Total time from vial puncture to the completion of the intravesical instillation should not exceed 2 hours.

USE IN SPECIFIC POPULATIONS

Pregnancy: May cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.

ADVERSE REACTIONS

The most common (≥15%) adverse reactions, including laboratory test abnormalities, are increased creatinine, dysuria, hematuria, urinary frequency, micturition urgency, urinary tract infection, increased potassium, musculoskeletal pain, chills and pyrexia.

For more information about ANKTIVA, please see the Full Prescribing Information at www.anktiva.com.

You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.FDA.gov/medwatch or call 1-800-332-1088. You may also contact lmmunityBio at 1-877-ANKTIVA (1-877-265-8482)

When BCG Alone Isn’t Enough,

Bring On the Tri-Offense With Anktiva.

For more information, please call 1-877-ANKTIVA.