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IS ANKTIVA + BCG RIGHT FOR YOU?

Go ahead and TRI.

Not an actual patient.

Anktiva is an Immunotherapy that Activates Your Body’s Cancer Fighting Cells

Anktiva is the first U.S. FDA-approved immunotherapy that activates a type of cell called a natural killer (NK) cell, part of the body’s natural immune system, to attack and kill non-muscle invasive bladder cancer (NMIBC) cells.1 Anktiva is a treatment for use in combination with a standard treatment for NMIBC, bacillus Calmette-Guérin (BCG), for people with NMIBC for whom BCG alone was not effective or in whom NMIBC returned after initial successful treatment. These people have what is termed BCG-unresponsive NMIBC.

Gloved hands holding a syringe labeled "ANKTIVA 400mcg + BCG 50mg" connected to a catheter, in a blurred clinical setting

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: 61.1-79.6)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.

NR, not yet reached.

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

Anktiva (nogapendekin alfa inbakicept-pmln) solution 400 mcg/0.4 mL product packaging and single-dose vial for intravesical use, manufactured by ImmunityBio.

Who Should Consider Anktiva?

Anktiva is a treatment for adults who have all the following1:

  • High-risk non-muscle invasive bladder cancer (NMIBC)
  • NMIBC that did not or is no longer responding to BCG therapy alone (BCG-unresponsive)
  • NMIBC that has not grown beyond the inner lining of the bladder to the muscle underneath (called carcinoma in situ or CIS disease)
  • NMIBC with or without small finger-like tumor growths that project away from the bladder wall into the bladder (papillary disease)

If You Have Been Diagnosed With BCG-Unresponsive NMIBC With CIS Disease and Are Interested in Anktiva, Here Is What You Need to Know:

What Anktiva is

  • Anktiva is an immunotherapy that activates your body’s natural immune system
  • Anktiva is used in combination with BCG and is administered directly into your bladder via a catheter intravesically
  • Anktiva is the first treatment of its type approved to treat BCG-unresponsive NMIBC with CIS

What Anktiva is not

  • Anktiva is not a chemotherapy
  • Anktiva is not administered via IV. It only fights cancer in the bladder
  • Anktiva is not an indirect mechanism, it directly stimulates the immune response

Getting Started With Anktiva

See how Anktiva works with BCG in the Tri-offense and what to expect before and after treatment

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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.