FDA-approved Immunotherapy Treatment for NMIBC CIS

complete response ability.

62% complete response rate.¹

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

Help your immune system fight back. Anktiva works with Bacillus Calmette-Guérin (BCG) to activate your body’s natural defenses against BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) using the Tri-offense.¹

There is no quit in his fight

Help your immune system fight back. Anktiva works with Bacillus Calmette-Guérin (BCG) to activate your body’s natural defenses against BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) using the Tri-offense.¹

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.^1,2

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

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

NR, not yet reached.

Infographic diagram on black background titled “TRI-OFFENSE” in a central yellow banner, showing Anktiva’s three-pronged immune mechanism in a large inverted triangle: top gray section activates natural killer cells to kill evasive cancer cells (yellow icon); bottom-left blue section attacks with CD8+ killer T cells to eliminate cancer and prime memory cells (blue icon); bottom-right purple section drives memory T cells for ongoing bladder cancer recognition (pink icon).

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)
Adverse Reactions	All Grades, %	Grades 3 or 4, %
Dysuria	32	0
Hematuria^a	32	3.4
Urinary Frequency	27	0
Micturition Urgency^a	25	0
Urinary Tract Infection^a	24	2.3
Musculoskeletal Pain^a	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)
Adverse Reactions	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%).

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.