On October 6, 2020 NantKwest, Inc. (NASDAQ: NK), a clinical-stage, natural killer cell-based therapeutics company, and ImmunityBio, a privately-held immunotherapy company, reported they have added a third cohort to their ongoing Phase 2 trial of a novel immunotherapy for locally advanced or metastatic pancreatic cancer (Press release, NantKwest, OCT 6, 2020, View Source [SID1234568167]). The third cohort enables pancreatic cancer patients who have failed all approved standards of care to participate in the trial.

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The randomized, open-label study is evaluating safety and efficacy of a combination immunotherapy comprising NantKwest’s PD-L1 t-haNK, ImmunityBio’s IL-15 superagonist Anktiva (N-803), and aldoxorubicin, plus standard of care. The results will be compared to standard-of-care chemotherapy for first- and second-line treatment; the third-line cohort is a single arm, with no comparator. Each cohort will be studied independently to provide more precise comparative data for each disease stage.

"Pancreatic cancer is one of the deadliest forms of cancer, with a five-year survival rate of just five percent, so new and more effective therapies are desperately needed," said Patrick Soon-Shiong, M.D., Chairman and Chief Executive Officer of NantKwest and ImmunityBio. "By adding the third cohort to this important study, we’re able to enroll patients at all stages of the disease, even those who experience disease progression after the first- or second-line treatment."

Trial Sites and Enrollment

Currently, three trial sites have been activated: Hoag Memorial Hospital Presbyterian in Orange County, Calif., The Chan Soon-Shiong Institute for Medicine in Los Angeles County, Calif., and Avera McKennan Hospital and University Health Center in Sioux Falls, South Dakota, which will serve patients in the tri-state area (Iowa, Nebraska and South Dakota). Forty patients are currently enrolled in or being evaluated for the trial.

NantKwest and ImmunityBio’s combination immunotherapy is designed to harness the body’s immune system to target, kill, and "remember" cancer cells. The agents in this trial are designed to find pancreatic cancer cells and initiate a large immune response against them. This may allow the body to develop its own antibodies to fight the cancer.

"Our research in pancreatic cancer, as well as many other forms of cancer, is focused on how we can recruit and amplify the power of the human body’s own immune system to target and destroy even the most difficult cancer cells," said Dr. Soon-Shiong. "Our goal is to attack the disease aggressively so that we can provide more time and a higher quality of life to patients who today have a very poor prognosis."

Study Details

This Phase 2, randomized, three-cohort, open-label study will evaluate the comparative efficacy and overall safety of standard-of-care chemotherapy versus standard-of-care chemotherapy, in combination with PD-L1 t-haNK, Anktiva (N-803), and aldoxorubicin in subjects with locally advanced or metastatic pancreatic cancer (QUILT-88, NCT04390399). Each treatment setting, as well as each first- and second-line or later maintenance treatment, will be evaluated independently as Cohort A, Cohort B, and Cohort C, respectively, with cohorts A and B having independent experimental and control arms. The study will initially enroll 298 subjects across all three cohorts. The primary objective of cohorts A and B is progression-free survival (PFS) and the objective of cohort C is overall survival (OS) per RECIST V1.1. Secondary objectives include initial safety and additional efficacy measures, including overall response rate (ORR), complete response (CR) rate, durability of response (DoR), disease control rate (DCR), and overall survival (OS).

Pancreatic cancer is the fourth leading cause of cancer-related death in the US, with an estimated 47,050 deaths and 57,600 new cases expected in 2020.1. It is the 12th most common cancer worldwide, with around 338,000 new cases diagnosed in 2012 (2% of all cancer diagnoses).

1.Siegel RL, Miller KD, and Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020;70:7-30