ANKTIVA
Generic: NOGAPENDEKIN ALFA INBAKICEPT-PMLN
Basic Information
Manufacturer
Altor BioScience, LLC, an indirect wholly-owned subsidiary of ImmunityBio, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVESICAL
FDA Set ID
eae31db8-3e7a-d9e0-708d-74419d1b50ff
Indications & Usage
1 INDICATIONS 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.
ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.
( 1 )
ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.
( 1 )
Adverse Reactions
6 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.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Altor BioScience, LLC, an indirect wholly-owned subsidiary of ImmunityBio, Inc.
at toll-free phone 877-265-8482 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of ANKTIVA with BCG was evaluated in Cohort A of QUILT-3.032, a single-arm, multicenter clinical study in 88 patients with BCG-unresponsive high-grade NMIBC with CIS with or without Ta/T1 papillary disease [see Clinical Studies ( 14 )].
Patients received 400 mcg ANKTIVA with BCG weekly for 6 consecutive weeks during induction and then once a week for 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 at 3 months were eligible to receive a second induction.
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.
The median number of doses of ANKTIVA with BCG administered to patients was 12 (range 2 – 30) doses.
The median duration of exposure to ANKTIVA with BCG was 7.1 months (range: 0.26 to 36.3 months).
Serious adverse reactions occurred in 16% of patients receiving ANKTIVA with BCG.
Serious adverse reactions that occurred in ≥2% of patients who received ANKTIVA with BCG included hematuria (3.4%).
A fatal adverse reaction of cardiac arrest occurred in 1 (1.1%) patient receiving ANKTIVA with BCG.
Permanent discontinuation of ANKTIVA with BCG due to adverse reactions occurred in 7% of patients.
Adverse reactions (>2%) resulting in permanent discontinuation of ANKTIVA with BCG included musculoskeletal pain (2.3%).
Dosage interruptions due to adverse reactions occurred in 34% of patients receiving ANKTIVA with BCG.
Adverse reactions (≥5%) that resulted in interruption of ANKTIVA with BCG were urinary tract infection (10%), dysuria (8%), hematuria (6%), and bladder irritation (6%).
Dosage reductions due to adverse reactions were not permitted for ANKTIVA; however, dose reduction of BCG was allowed for adverse reactions and occurred in 3.4% of patients including (>1%) urinary tract infection (2.3%), hematuria (1.1%), urinary frequency (1.1%), and bladder irritation (1.1%).
The most common (≥15%) adverse reactions, including laboratory test abnormalities, were increased creatinine, dysuria, hematuria, urinary frequency, micturition urgency, urinary tract infection, increased potassium, musculoskeletal pain, chills and pyrexia.
Table 1 summarizes the adverse reactions in Cohort A of QUILT-3.032.
Table 1: Adverse Reactions Occurring in ≥15% of Patients in Cohort A in QUILT-3.032 1 Includes other related terms Adverse Reaction ANKTIVA with BCG (n=88) All Grades % Grades 3 or 4 % Dysuria 32 0 Hematuria 1 32 3.4 Urinary Frequency 27 0 Micturition Urgency 1 25 0 Urinary Tract Infection 1 24 2.3 Musculoskeletal Pain 1 17 2.3 Chills 15 0 Pyrexia 15 0 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%).
Table 2 summarizes the laboratory test abnormalities occuring in ≥15% of patients in QUILT-3.032.
Table 2: Select Laboratory Test Abnormalities (≥15%) That Worsened From Baseline in Patients in Cohort A of QUILT-3.032 1 The denominator used to calculate the rates was 88 based on the number of patients with a baseline value and at least one post-treatment value.
Laboratory Abnormality ANKTIVA with BCG 1 (n=88) All Grades % Grades 3 or 4 % Increased Creatinine 76 0 Increased Potassium 18 2
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Altor BioScience, LLC, an indirect wholly-owned subsidiary of ImmunityBio, Inc.
at toll-free phone 877-265-8482 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of ANKTIVA with BCG was evaluated in Cohort A of QUILT-3.032, a single-arm, multicenter clinical study in 88 patients with BCG-unresponsive high-grade NMIBC with CIS with or without Ta/T1 papillary disease [see Clinical Studies ( 14 )].
Patients received 400 mcg ANKTIVA with BCG weekly for 6 consecutive weeks during induction and then once a week for 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 at 3 months were eligible to receive a second induction.
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.
The median number of doses of ANKTIVA with BCG administered to patients was 12 (range 2 – 30) doses.
The median duration of exposure to ANKTIVA with BCG was 7.1 months (range: 0.26 to 36.3 months).
Serious adverse reactions occurred in 16% of patients receiving ANKTIVA with BCG.
Serious adverse reactions that occurred in ≥2% of patients who received ANKTIVA with BCG included hematuria (3.4%).
A fatal adverse reaction of cardiac arrest occurred in 1 (1.1%) patient receiving ANKTIVA with BCG.
Permanent discontinuation of ANKTIVA with BCG due to adverse reactions occurred in 7% of patients.
Adverse reactions (>2%) resulting in permanent discontinuation of ANKTIVA with BCG included musculoskeletal pain (2.3%).
Dosage interruptions due to adverse reactions occurred in 34% of patients receiving ANKTIVA with BCG.
Adverse reactions (≥5%) that resulted in interruption of ANKTIVA with BCG were urinary tract infection (10%), dysuria (8%), hematuria (6%), and bladder irritation (6%).
Dosage reductions due to adverse reactions were not permitted for ANKTIVA; however, dose reduction of BCG was allowed for adverse reactions and occurred in 3.4% of patients including (>1%) urinary tract infection (2.3%), hematuria (1.1%), urinary frequency (1.1%), and bladder irritation (1.1%).
The most common (≥15%) adverse reactions, including laboratory test abnormalities, were increased creatinine, dysuria, hematuria, urinary frequency, micturition urgency, urinary tract infection, increased potassium, musculoskeletal pain, chills and pyrexia.
Table 1 summarizes the adverse reactions in Cohort A of QUILT-3.032.
Table 1: Adverse Reactions Occurring in ≥15% of Patients in Cohort A in QUILT-3.032 1 Includes other related terms Adverse Reaction ANKTIVA with BCG (n=88) All Grades % Grades 3 or 4 % Dysuria 32 0 Hematuria 1 32 3.4 Urinary Frequency 27 0 Micturition Urgency 1 25 0 Urinary Tract Infection 1 24 2.3 Musculoskeletal Pain 1 17 2.3 Chills 15 0 Pyrexia 15 0 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%).
Table 2 summarizes the laboratory test abnormalities occuring in ≥15% of patients in QUILT-3.032.
Table 2: Select Laboratory Test Abnormalities (≥15%) That Worsened From Baseline in Patients in Cohort A of QUILT-3.032 1 The denominator used to calculate the rates was 88 based on the number of patients with a baseline value and at least one post-treatment value.
Laboratory Abnormality ANKTIVA with BCG 1 (n=88) All Grades % Grades 3 or 4 % Increased Creatinine 76 0 Increased Potassium 18 2