BLADDER CANCER
Bladder cancer is one of the more common forms of cancer. Approximately 75% to 80% of newly diagnosed bladder cancers are classified as non-muscle invasive bladder cancer (NMIBC)—a type of cancer that has grown through the lining of the bladder but has not yet invaded the muscle layer. NMIBC is associated with high rates of recurrence (between 30% and 80%) and the risk of progression to invasive and metastatic disease. Treatment and care of individuals with high-risk NMIBC, including those with carcinoma in situ (CIS), often involves removing the tumor followed by Bacillus Calmette-Guérin (BCG) bladder instillation therapy to reduce the risk of recurrence. Few effective treatment options exist for patients who develop BCG-unresponsive disease. The failure to achieve a complete response, or the disappearance of all signs of cancer as seen on cystoscopy, biopsied tissue, and urine, is associated with an increased risk of death or a disease-worsening event.
NOGAPENDEKIN ALFA INBAKICEPT-PMLN (ANKTIVA)
Nogapendekin alfa inbakicept-pmln (Anktiva) is an interleukin-15 (IL-15) receptor agonist indicated with BCG for the treatment of adult patients with BCG-unresponsive NMIBC with CIS with or without papillary tumors.
PEER-REVIEWED LITERATURE
SUMMARY
The safety and effectiveness of nogapendekin alfa inbakicept-pmln (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. Patients received 400 mcg nogapendekin alfa inbakicept-pmln (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 nogapendekin alfa inbakicept-pmln (Anktiva) with BCG administered to patients was 12 (range, 2–30) doses. The median duration of exposure to nogapendekin alfa inbakicept-pmln (Anktiva) with BCG was 7.1 months (range, 0.26–36.3 months).
Serious adverse reactions occurred in 16% of patients receiving nogapendekin alfa inbakicept-pmln (Anktiva) with BCG. Serious adverse
reactions that occurred in 2% or more of patients who received (Anktinva) nogapendekin alfa inbakicept-pmln (Anktiva) with BCG included hematuria (3.4%). A
fatal adverse reaction of cardiac arrest occurred in one (1.1%) patient receiving nogapendekin alfa inbakicept-pmln (Anktiva) with BCG. 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. Clinically relevant adverse reactions in fewer than 15% of patients who received nogapendekin alfa inbakicept-pmln (Anktiva) with BCG included fatigue
(14%), nausea (14%), bladder irritation (11%), diarrhea (9%), and nocturia (7%).
OFF-LABEL INDICATIONS
There may be additional indications contained in the Policy section of this document due to the evaluation of criteria highlighted in the Company's off-label policy, and/or review of clinical guidelines issues by leading professional organizations and government entities.
