NantKwest, Inc. and ImmunityBio, Inc. 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. 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.