In the U.S., pancreatic cancer is the fourth leading cause of cancer-related death in both men and women and has one of the highest mortality rates of all major cancers, taking nearly 50,000 lives every year, with a five-year survival rate for late-stage cases of only 3%, according to the American Society of Clinical Oncology.
Pancreatic Cancer Clinical Trial
ImmunityBio has previously conducted exploratory Phase 1b/2 trials in patients with second-line or greater metastatic pancreatic cancer. The trials combined Anktiva and aldoxorubicin with off-the-shelf NK (haNK) cells, other agents, and stereotactic body radiotherapy (SBRT), and showed encouraging results in patients with advanced disease. On the basis of these exploratory trials and other preclinical findings, we initiated a first- through third-line pancreatic cancer clinical trial that uses our immunotherapy and cell therapy platforms.
QUILT 88 – Combination Immunotherapy Plus Standard-of-Care Chemotherapy Versus Standard-of-Care Chemotherapy for First-and-Second Line Treatment of Locally Advanced or Metastatic Pancreatic Cancer.
This is a phase 2, three-cohort, open-label study to evaluate the comparative efficacy and overall safety of standard-of-care chemotherapy versus standard-of-care chemotherapy in combination with aldoxorubicin, Anktiva (N-803), and PD-L1 t-haNK in subjects with locally advanced or metastatic pancreatic cancer. Each treatment setting (i.e., first- and second-line advanced and third-line and beyond) will be evaluated independently as a separate cohort. As of January, 2023, the median overall survival rate in this highly advanced group of patients was 6.3 months, more than double the historic survival rate.
Our unique approach to orchestrating the innate and adaptive immune systems to induce immunogenic cell death may provide an important new option for pancreatic cancer patients, who have a poor prognosis and are among the most challenging cancer patients to treat.