For information regarding recent FDA correspondence, please read the press release.

IS ANKTIVA 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.

Medical preparation setup in a clinical setting: three small glass vials with green caps and labels (containing BCG and ANKTIVA) placed on a sterile blue drape next to a red catheter tubing, white gauze pad, and blurred healthcare professional in mask and gown in the background

QUILT-3.032 Study

Primary Endpoint
62%cr

of study participants achieved a complete response, meaning their cancer was eliminated

(n=77; 95% CI: 51-73).1

Biopsy confirmed.

Duration of Response
Up to
47+ Months

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

Primary Endpoint
71%cr

of study participants had a complete response

(n=100; 95% CI: 61.1-79.6).2

Biopsy confirmed.

Duration of Response
Up to
53+ Months

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.

Gemini said 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 following:

  • High-risk non-muscle invasive bladder cancer
  • 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

A patient-friendly overview of how Anktiva plus BCG work together, as well as what patients should expect before and after treatment

Patient Stories

Patients Like You

Read about patients who participated in the clinical trials for Anktiva

Justin’s Journey

Justin’s Journey

An avid outdoorsman, Justin faced a challenging diagnosis of non-muscle invasive bladder cancer. After struggling with the side effects of his Bacillus Calmette-Guérin (BCG) treatment, he found renewed hope though his doctors' introduction to an immunotherapy for those who experienced a recurrence of NMIBC.

Learn More

Wayne’s Journey

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.

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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.