A new frontier of immunotherapy for bladder cancer
Anktiva plus BCG works by turning back on natural killer cells that have learned to evade the immune system.
N-803, also known as nongapendekin alfa inbakicept, or Anktiva, with BCG is a new standard of care for patients with non-muscle invasive bladder cancer carcinoma in situ (NMIBC CIS) who have failed Bacillus Calmette-Guerin (BCG) and other therapies.
Anktiva received Breakthrough Therapy Designation and approval from the FDA on April 22, 2024, based on interim safety, efficacy and complete response and duration of complete response data from QUILT 3032, an open-label, three-cohort, multicenter phase 2/3 study, with a cutoff of Nov. 30, 2023. The interleukin-15 immunotherapy plus BCG helps harness the natural power of the immune system to attack bladder cancer, leading to a long-term duration of complete response that, for some patients, exceeds 47 months. Patients’ tumor status will continue to be assessed with cystoscopy and urine cytology for up to five years.
“Median duration is yet to be determined, and duration is everything,” said Patrick Soon-Shiong, MD, executive chair, global chief scientific and medical officer of ImmunityBio. On Friday afternoon, Dr. Soon-Shiong spoke with Sam Chang, MD, MBA, the Patricia and Rodes Hart Endowed professor of urological surgery and oncology and the chief surgical officer at Vanderbilt University Medical Center, during an engaging conversation in the Learning Lab about the new FDA approval of Anktiva and the next generation of immunotherapy for NMIBC.
“Anktiva not only proliferates and activates the patient’s own natural killer cells and CD8+ killer T cells, but it activates CD4+ T helper cells to enhance the proliferation of memory killer T cells, to mount ‘a triangle offense’ against bladder cancer,” Dr. Soon-Shiong said. “With Anktiva, we have found a way to reactivate natural killer cells, turning cold tumors that have learned to evade the immune system into hot tumors that respond to therapy,” he said.
“The FDA’s approval of Anktiva marks the launch of a next-generation immunotherapy beyond checkpoint inhibitors,” Dr. Soon-Shiong said. Anktiva is expected to be available in the U.S. momentarily. ImmunityBio has its own U.S.-based large-scale facilities that will produce both Anktiva and BCG, with special distributors “up and ready.”
Anktiva will be available to all patients who need it. “I’m most proud of our patient assistance program, which will limit copays to $100 and provide the drug for free for patients without insurance who can’t afford it,” Dr. Soon-Shiong said.
Anktiva plus BCG for patients with NMIBC CIS is only the beginning. In development are studies investigating Anktiva plus BCG for all tumor types and the promise of the first cancer prevention vaccine for patients with Lynch syndrome, which carries an 80% chance of developing colon cancer.