FDA Approves ImmunityBio's Anktiva Combo

ImmunityBio, Inc. has announced the FDA approval of Anktiva (N-803, or Nogapendekin alfa inbakicept-PMLN) plus Bacillus Calmette-Guérin (BCG) for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. This novel immunotherapy activates the body’s natural killer (NK) and killer T-cell immune system to attack tumor cells. The therapy stimulates memory T cells, leading to a long duration of complete response exceeding 47 months and ongoing to date, with a median duration of response yet to be determined.

The efficacy outcome of complete responses (CR) and duration of complete response (DOR) in the single-arm, multicenter trial of 77 evaluable patients showed a CR rate of 62%, with the upper end of the confidence interval being 73%. The duration of complete response as of the November 2023 cut-off was more than 47 months and is ongoing to date. These prolonged duration of complete response results beyond 24 months with Anktiva and BCG exceed the benchmark for the magnitude of meaningful clinical results suggested by a panel of experts at the International Bladder Cancer Group (IBCG).

The press release indicates that 58% of patients with CR had a DOR ≥ 12 months and 40% had a DOR ≥ 24 months. Anktiva in combination with BCG is approved for maintenance therapy for up to 37 months with tolerable side effects ranging from 0% to 3% grade 3/4 adverse events.

Anktiva is expected to be available in the U.S. by mid-May 2024, and the company anticipates that it could represent a new standard of care for patients with NMIBC, potentially reducing the need for cystectomy in many patients worldwide.

Bladder cancer is the 10th most commonly diagnosed cancer globally, and in the U.S., the American Cancer Society estimates there will be 83,190 new cases and 16,840 deaths from bladder cancer in 2024. At the time of diagnosis, about 80% of cases are NMIBC.

Anktiva has been studied in more than 700 patients in multiple phase 1 and 2 trials in both liquid and solid tumors. In addition to trials in NMIBC, it is currently being studied in trials for non-small-cell lung cancer, colorectal cancer, non-Hodgkin’s lymphoma, glioblastoma, solid tumors, and HIV. Future studies are planned for platinum-resistant ovarian cancer and acute myeloid leukemia.

The company's management will discuss the FDA approval of Anktiva in combination with BCG for the treatment of BCG-unresponsive NMIBC via a conference call and webcast on April 26, 2024, at 11 am EDT. Today the company's shares have moved 1.4% to a price of $5.01. For more information, read the company's full 8-K submission here.

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