NantKwest, ImmunityBio Announce Positive Interim Data on Survival Rates in Metastatic Pancreatic Cancer Trials

NantKwest, Inc. (NASDAQ: NK), a clinical-stage, natural killer cell-based therapeutics company, and ImmunityBio, Inc., a privately-held immunotherapy company, today announced early interim results of its PD-L1 t-haNK protocols showing median survival rates more than doubled that of the historic rate in patients with advanced metastatic pancreatic cancer for which no other FDA-approved treatment exists. These trials, which were based on the original Cancer Moonshot hypothesis and exploratory QUILT trials initiated in 2017, appear to validate the theory that by orchestrating natural killer and T-cell therapy, survival rates could be improved without high-dose chemotherapy.

The early collaborative Cancer Moonshot trials involved the combination of cell therapy and immunotherapeutics from multiple biotech and pharmaceutical companies, including NantKwest, ImmunityBio, Celgene, and Pfizer. These trials explored the hypothesis that by activating the patient’s own immune system, a paradigm change in cancer therapy could evolve to eradicate cancer cells without high-dose chemotherapy. From 2017 to 2020, multiple QUILT clinical trials exploring this combination of cell therapy, immunomodulating antibodies, adenovirus-based cancer vaccines, and low-dose chemotherapy provided preliminary results showing the median survival rate can be more than doubled and a complete remission can be achieved in patients with metastatic pancreatic cancer for which there are no other FDA-approved treatment options. Based on the data from these trials, ImmunityBio is conducting a pivotal, three-cohort pivotal trial (QUILT 88) in metastatic pancreatic cancer.

Interim Study Results

• In the Cancer Moonshot QUILT trials of haNK combined with PD-L1 inhibitor avelumab, which were completed in 2019, the median overall survival rate more than doubled (three months historic control versus 8 months in the treatment arm) in the 12-patient study. See related press release here for details.
• A complete remission was achieved when replacing haNK and PD-L1 inhibitor avelumab with PD-L1 t-haNK and four out of five patients who had not yet reached median survival time (three months) are alive 8-16 months since beginning treatment on these expanded protocols
• A single-arm Phase 2 study (QUILT 88, Cohort C) was initiated in October 2020, for which the primary endpoint is overall survival and 15 out of 18 (83%) of patients enrolled with second-line or greater pancreatic cancer remain alive to date.
• A randomized Phase 2 study (QUILT 88, Cohorts A and B) for first- and second-line metastatic pancreatic cancer is actively enrolling at three sites.

“The goal of the Cancer Moonshot program was to explore the hypothesis that by orchestrating natural killer cells and T cells, a paradigm change for the treatment of cancer could evolve. The initial results of these Cancer Moonshot trials combining immunotherapy molecules—including Abraxane from Celgene, haNK from NantKwest, Anktiva from ImmunityBio, and a PD-L1 inhibitor Avelumab from Pfizer—provided promising early data that a doubling of median overall survival rate in patients with advanced metastatic disease across multiple tumor types was possible,” said Patrick Soon-Shiong, M.D., Chairman, and CEO of ImmunityBio.