The Food and Drug Administration (FDA) has approved Anktiva, an immunotherapy developed by ImmunityBio, for the treatment of bladder cancer in patients unresponsive to standard Bacillus Calmette-Guerin (BCG) therapy. This approval marks a significant advancement in bladder cancer treatment, offering a new option for patients who have exhausted conventional therapies. The clinical trial leading to this approval was spearheaded by UCLA, demonstrating that patients responding to Anktiva were less likely to require complete or partial bladder removal surgery.
Clinical Trial Results
In a clinical trial, patients treated with Anktiva in combination with BCG showed significantly better outcomes compared to those who received Anktiva alone. Among 82 patients who received both drugs, 55% had a successful response at three months, 56% at six months, and 45% after a full year. Specifically, in a group of 72 patients with a certain type of bladder cancer, 55.4% had a successful response at 12 months, decreasing to 48% by 24 months. The median duration of cancer-free status post-treatment was 19.3 months, as reported in NEJM Evidence. The most common side effects included pain or discomfort during urination, frequent urination, and blood in the urine.
Mechanism of Action and Clinical Significance
Anktiva is designed to mimic a type of cell that stimulates the immune system to produce memory killer T cells, which recognize and attack bladder cancer cells. Dr. Karim Chamie, who led the clinical trial, stated that Anktiva offers a compelling alternative for patients who have exhausted conventional treatment options, providing a long-lasting response and demonstrating improved safety and efficacy compared to other options for BCG-unresponsive patients.
Bladder Cancer Landscape
Bladder cancer is a significant health concern, with the National Cancer Institute estimating 83,190 new diagnoses and 16,840 deaths in the United States this year. It accounts for 4.2% of all new cancer cases and 2.8% of cancer deaths, with a higher prevalence in individuals aged 65 and older and in men. The first-line treatment typically involves surgical removal of visible tumors, followed by BCG administration. However, approximately 20% of patients do not respond to BCG, often leading to bladder removal surgery.
Expert Commentary and Availability
Dr. Ashish Kamat noted the excitement of developing a new immunotherapy that builds on BCG knowledge. However, Dr. Kyle Richard pointed out the current worldwide shortage of BCG, which could limit Anktiva's accessibility. ImmunityBio anticipates Anktiva's availability by mid-May. Evaluate has estimated that the drug could reach $878 million in annual sales by 2028.
