- Third cohort added to independently evaluate the efficacy of NantKwest’s PD-L1 t-haNK natural killer cells plus ImmunityBio’s IL-15 superagonist Anktiva™ (N-803) in third-line or greater therapy for patients with locally advanced or metastatic pancreatic cancer.
- Two other cohorts for first-line maintenance and second-line randomized against standards of care chemotherapy.
- 40 patients are currently enrolled in or being evaluated for the Phase 2 trial at three sites.
- Metastatic pancreatic cancer patients treated with PD-L1 t-haNK and Anktiva (N-803) through single-patient Expanded Access INDs continue to have ongoing stable disease and a durable complete response >11 months after initial treatment.
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
Trial Sites and Enrollment
Currently, three trial sites have been activated:
“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
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
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Forward-looking statements are based on management’s current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements.
These and other risks regarding NantKwest’s business are described in detail in its
ImmunityBio’s platform is based on the foundation of three separate modalities: antibody cytokine fusion proteins, synthetic immunomodulators, and second-generation human adenovirus (hAd5) vaccine technologies.
Anktiva™ (ImmunityBio’s lead cytokine infusion protein) is a novel interleukin-15 (IL-15) superagonist complex and has received Breakthrough Therapy and Fast Track Designations from the
ImmunityBio is also developing therapies, including vaccines, for the prevention and treatment of HIV, influenza, and the coronavirus SARS-CoV-2 with its second-generation human adenovirus (hAd5) vaccine technologies.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements concerning or implying that ImmunityBio will be successful in improving the treatment of various diseases, including, but not limited to the novel coronavirus and cancer. Risks and uncertainties related to this endeavor include, but are not limited to, the company’s beliefs regarding the success, cost, and timing of its development activities and clinical trials.
Forward-looking statements are based on management’s current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. These forward-looking statements speak only as of the date hereof, and we disclaim any obligation to update these statements except as may be required by law.
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