Data presented in bladder and pancreatic cancer at ASCO underscore the company’s vision of using NK cells and T cells to target difficult-to-treat cancers.
ImmunityBio Executive Chairman Patrick Soon Shiong/Courtesy of ImmunityBio
ImmunityBio posted positive data from two oncology studies in its QUILT program, one in bladder cancer and one in pancreatic cancer. Data from both studies underscore the company’s vision of using NK cells and T cells to target difficult-to-treat cancers.
At the American Society of Oncology’s annual meeting, California-based Patrick Soon Shiong, executive chairman and global chief scientific and medical officer at ImmunityBio, said combination therapies and immunotherapies are an important theme being presented at the annual oncology meeting. For ImmunityBio, Soon Shiong said the data presented is validation of the approach that uses a combination of NK and T cells. That approach could lead to potential regulatory approval of the company’s therapy, Anktiva, in bladder cancer.
In the Phase II/III QUILT 3032 study, ImmunityBio said 71% of patients with non-muscle invasive bladder cancer patients who were unresponsive to Bacillus Calmette-Guérin demonstrated a complete response following treatment with the company’s IL-15 superagonist Anktiva (N-803). Those patients saw a median duration of response of 26.6 months, the company said. Data also showed a 96% avoidance of bladder cancer progression at 24 months in responders, the company said.
Additionally, ImmunityBio said the QUILT 3032 patients had a cystectomy avoidance rate of 91% and 100% bladder cancer overall survival at 24 months. Cystectomy is an aggressive surgery to remove the entire bladder.
Prior to the start of ASCO ImmunityBio submitted a Biologics License Application to the U.S. Food and Drug Administration for Anktiva plus Bacillus Calmette-Guérin (BCG) for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS) with or without Ta or T1 disease. The BLA is supported by data from the QUILT 3032 study. If approved, this combination would be the first new immunotherapy for this indication in 23 years that can be delivered directly to the bladder to induce natural killer cells and T cells.
The FDA previously granted Anktiva Breakthrough Therapy and Fast Track designations when used in combination with BCG for the treatment of BCG-unresponsive NMIBC CIS.
The Phase II QUILT 88 study in advanced metastatic pancreatic cancer also saw positive results. ImmunityBio said treatment with its Nant Vaccine, which combines the company’s adenoviral and yeast-based cancer antigen vaccines with its proprietary natural killer cell platform and Anktiva, provided patients with more than double the median overall survival rate compared to historical survival data for these patients. Median overall survival for patients with third- to sixth-line pancreatic cancer was 6.2 months, the company said.
Sandeep Bobby Reddy, chief medical officer at ImmunityBio noted that bladder cancer and pancreatic cancer combine to claim more than 500,000 lives each year across the globe. Many patients with both types of cancer often fail on current standards of care, Reddy said.
“In dozens of studies, we have shown that N-803 proliferates NK and T cells and thus serves as an enhancing secondary boost, augmenting the immunological response when given in combination with BCG or a checkpoint inhibitor. This mechanism of action of inducing trained innate immune memory, through the combination of N-803 and a prime, contributes we believe to the compelling results we’re seeing in these important trials,” Reddy said in a statement.
