FDA approved Anktiva (Nogapendekin Alfa Inbakicept) with BCG for BCG-Unresponsive NMIBC with CISFDA approved new bladder cancer drug for patients who did not respond to standard therapy

Anktiva is an interleukin-15 (IL-15) receptor agonist. The exact mechanism of action in combination with BCG is not fully described in the label.

Anktiva, in combination with 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. BCG-unresponsive high-risk NMIBC was defined in the trial 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 at least 5 of 6 doses of an initial induction course plus either at least 2 of 3 doses of maintenance therapy or at least 2 of 6 doses of a second induction course.

For intravesical use only. Do not administer by subcutaneous, intravenous, or intramuscular routes.

Induction: 400 mcg administered intravesically with BCG once a week for 6 weeks. A second induction course may be administered if complete response is not achieved at month 3.

Maintenance: After induction, 400 mcg with BCG once a week for 3 weeks at months 4, 7, 10, 13, and 19 (total of 15 doses). For patients with an ongoing complete response at month 25 and later, additional maintenance instillations with BCG may be administered once a week for 3 weeks at months 25, 31, and 37 (maximum of 9 additional instillations).

The recommended duration of treatment is until disease persistence after second induction, disease recurrence or progression, unacceptable toxicity, or a maximum of 37 months.

Preparation: Draw 0.4 mL of Anktiva into a small syringe and add to the saline containing the BCG suspension. Mix gently and withdraw to a final volume of 50 mL. Total time from vial puncture to completion of instillation should not exceed 2 hours. If not used immediately, store refrigerated at 2°C to 8°C and use within 2 hours.

Administration: Instill the admixture into the bladder via catheter. Retain for 2 hours and then void. Do not repeat dose if patient voids before 2 hours.

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. Prior to treatment, all patients with Ta or T1 disease had undergone TURBT to remove all resectable disease. Residual CIS not amenable to complete resection was permitted. The trial excluded patients with muscle invasive, locally advanced, metastatic, or extra-vesical bladder cancer. Patients received 400 mcg Anktiva with BCG weekly for 6 consecutive weeks during induction, then once a week every 3 weeks at months 4, 7, 10, 13, and 19 for patients with no or low grade disease. Patients with persistent CIS or high grade Ta disease at 3 months were eligible for a second induction course. Patients with ongoing CR at 25 months were eligible for additional instillations at months 25, 31, and 37. Assessment of tumor status was performed every 3 months for up to two years. The major efficacy outcome measures were complete response at any time and duration of response. Complete response rate and duration data are