Brand Name
Anktiva
Generic Name
Nogapendekin
View Brand Information FDA approval date: May 06, 2024
Classification: Interleukin-15 Receptor Agonist
Form: Solution
What is Anktiva (Nogapendekin)?
ANKTIVA in combination with Bacillus Calmette-Guérin is indicated for the treatment of adult patients with BCG-unresponsive nonmuscle invasive bladder cancer with carcinoma in situ with or without papillary tumors. ANKTIVA is an interleukin-15 receptor agonist indicated with Bacillus Calmette-Guérin for the treatment of adult patients with BCG-unresponsive nonmuscle invasive bladder cancer with carcinoma in situ with or without papillary tumors.
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Brand Information
ANKTIVA (nogapendekin alfa inbakicept-pmln)
1INDICATIONS AND USAGE
ANKTIVA in combination with Bacillus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.
2DOSAGE FORMS AND STRENGTHS
400 mcg/0.4 mL, clear to slightly opalescent and colorless to slightly yellow solution in single-dose vials for intravesical instillation after dilution.
3CONTRAINDICATIONS
None
4DESCRIPTION
Nogapendekin alfa inbakicept-pmln is an interleukin-15 (IL-15) receptor agonist. It is a soluble complex consisting of (a) nogapendekin alfa (a human IL-15N72D variant, 114 amino acids) bound to (b) inbakicept [a dimeric human IL-15Rα sushi domain (65 amino acids)/human IgG1 Fc fusion protein (232 amino acids)]. Each fully assembled nogapendekin alfa inbakicept-pmln complex consists of a single inbakicept and two nogapendekin alfa components. Each IL-15N72D component is bound to one of the IL-15Rα sushi domains.
The recombinant protein complex is produced by a recombinant cell line that was created by transfecting a Chinese hamster ovary (CHO-K1) cell line with plasmids carrying genes for the IL-15N72D and IL-15RαSu/IgG1 Fc proteins. Purification of the product is achieved by conventional chromatography. The molecular weight of the deglycosylated nogapendekin alfa inbakicept-pmln complex is 92,106.5 Da. The molecular weights of the individual deglycosylated sub-units are 66565.6 Da (dimer) and 12,770.45 Da for the IL-15RαSu/IgG1 Fc domain and the IL-15N72D domain, respectively.
ANKTIVA (nogapendekin alfa inbakicept-pmln) solution is a clear to slightly opalescent, colorless to slightly yellow solution provided in a single-dose vial containing 400 mcg in 0.4 mL for intravesical administration upon dilution
5CLINICAL STUDIES
The efficacy of ANKTIVA was evaluated in QUILT-3.032 (NCT03022825), a single-arm, multicenter trial in 77 adults with BCG-unresponsive, high-risk, NMIBC with CIS with or without Ta/T1 papillary disease following transurethral resection.
BCG unresponsive high-risk NMIBC CIS was defined as persistent or recurrent CIS alone or with Ta/T1 disease within 12 months of completion of adequate BCG therapy. Adequate BCG therapy was defined as administration of at least 5 of 6 doses of an initial induction course plus either of at least 2 of 3 doses of maintenance therapy or at least 2 of 6 doses of a second induction course. Prior to treatment, all patients with Ta or T1 disease had undergone transurethral resection of bladder tumor (TURBT) to remove all resectable disease. Residual CIS not amenable to complete resection, fulguration, or cauterization was permitted. The trial excluded patients with history of or evidence of muscle invasive (i.e., T2, T3, T4), locally advanced, metastatic, and/or extra-vesical (i.e., urethra, ureter, or renal pelvis) bladder cancer.
Patients received 400 mcg ANKTIVA with BCG weekly for 6 consecutive weeks during the induction treatment period and then once a week every 3 weeks at 4, 7, 10, 13, and 19 months for patients with no or low grade disease. Patients with persistent CIS or high grade Ta disease at 3 months were eligible to receive a second induction course. Patients with ongoing CR at 25 months were eligible to receive additional instillations once a week every 3 weeks at months 25, 31, and 37. Assessment of tumor status was performed every 3 months for up to two years. Assessment for ongoing response beyond month 24 was per local community standards. Random or cystoscopy directed biopsies were required within the first 6 months after treatment initiation. The major efficacy outcome measures were complete response (CR) at any time (as defined by negative results for cystoscopy [with TURBT/biopsies as applicable] and urine cytology) and duration of response.
The median age of patients was 73 years (range, 50–91 years); 86% were male; race was White (90%), Black (6%), Asian (1%), American Indian or Alaska Native (1%), or Unknown (1%); and patients had baseline ECOG performance status of 0 (83%) or 1 (17%).
Tumor characteristics at study entry were CIS without Ta/T1 papillary disease (69%), CIS with Ta papillary disease (21%) or CIS with T1 +/- Ta papillary disease (10%). Baseline high-risk NMIBC disease status was 43% refractory and 57% relapsed. The median number of prior BCG doses received was 12 doses (range: 8–45 doses); 13% received partial-dose prior BCG. Baseline cystoscopy imaging modality was white light (57%), blue light or narrow band imaging (40%), and unknown (3%).
Efficacy results are summarized in Table 3. Thirty-one percent (n=24) of patients received a second induction course.
6HOW SUPPLIED/STORAGE AND HANDLING
ANKTIVA (nogapendekin alfa inbakicept-pmln) is clear to slightly opalescent and colorless to slightly yellow solution available in:
Carton containing 400 mcg/0.4 mL, single-dose vial (NDC 81481-803-01).
Store vials under refrigeration at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. Do not shake.
7PATIENT COUNSELING INFORMATION
Risk of Metastatic Bladder Cancer with Delayed Cystectomy
- Inform patients that delaying cystectomy could lead to development of metastatic bladder cancer. Discuss the risk of metastatic bladder cancer and that the risk increases the longer cystectomy is delayed in the presence of persisting CIS
Local Adverse Reactions Before and During Treatment
- Inform patients that irritable bladder symptoms may occur during instillation, and retention of ANKTIVA, and following voiding
- Inform patients that for the first 24 hours following administration, red-tinged urine may occur.
- Advise patients to immediately report prolonged irritable bladder symptoms or prolonged passage of red-colored urine to their healthcare provider.
- Instruct patients to maintain adequate hydration following ANKTIVA treatment.
Administration
- Inform patients that the ANKTIVA in combination with BCG admixture should be retained in the bladder for 2 hours and then voided.
- Advise patients that if unable to retain the suspension for 2 hours they can void sooner if necessary
- Instruct patients to void while seated to avoid splashing of urine.
Embryo-Fetal Toxicity
- Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females to inform their healthcare provider of a known or suspected pregnancy
- Advise females of reproductive potential to use effective contraception during treatment with ANKTIVA and for 1 week after the last dose
See the BCG prescribing information, Information for Patients for additional patient counseling information.
Manufactured for: Altor BioScience, LLC, an indirect wholly-owned subsidiary of ImmunityBio, Inc., Culver City, CA 90232 Manufactured by AGC Biologics, 21511 23