On October 13, 2021 ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, reported it has fully accrued the initial planned number of participants in Cohort C (third-line or greater) of its Phase 2 trial studying a combination immunotherapy (Nant Cancer Vaccine) in advanced metastatic pancreatic cancer (Press release, ImmunityBio, OCT 13, 2021, View Source [SID1234591162]). The majority of participants in the study to date remain on therapy and 90% (43/48) of the evaluable patients have exceeded the approximately two-month historical survival rate. Of the 48 evaluable patients, 23 (48%) had extremely advanced disease upon enrollment (i.e. had progressed after three to six prior lines of therapy) and, of these patients, 20 out of 23 (87%) have exceeded historical survival rates. On the strength of this early data and significant unmet medical need, the company has submitted an amendment to increase enrollment in Cohort C.

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"Patients with advanced metastatic pancreatic cancer who have failed all standards of care have very grave prognoses with few treatment options. This study was to explore if the Nant Cancer Vaccine could address this unmet need," said Patrick Soon-Shiong, M.D., Founder and Global Chief Scientific and Medical Officer of ImmunityBio, Inc. "It is gratifying to note that patients in this study, who had progressed after up to six lines of prior therapy, have exceeded historical survival rates despite having very advanced pancreatic cancer upon enrollment."

QUILT 88 is an open-label study to evaluate the safety and efficacy of the Nant Cancer Vaccine, comprising ImmunityBio’s IL-15 receptor agonist Anktiva (N-803), its off-the-shelf targeted natural killer cells (PD-L1 t-haNK), and aldoxorubicin, an albumin-modulated agent, plus low-dose chemotherapy. This combination therapeutic vaccine will be randomized against standard-of-care high-dose chemotherapy for first- and second-line treatment; the third-line cohort, with a target of 50 patients, is a single arm with the primary endpoint of overall survival.

Pancreatic cancer is the fourth leading cause of cancer-related death in the United States and has one of the highest mortality rates of all major cancers, taking nearly 50,000 lives in the U.S. every year. Surgery and subsequent adjuvant chemotherapy are the preferred treatment options for pancreatic cancer today and the five-year survival rate for late-stage cases is just 3%. For the majority of patients who present with more advanced disease, treatment typically consists of chemotherapy alone or supportive care for metastatic patients, and chemotherapy with or without radiation for those with locally advanced disease.

"Achieving robust enrollment in this patient group and early promising efficacy evidence are important milestones in ImmunityBio’s effort to develop this therapeutic with the potential to improve survival rates and provide a replacement for toxic chemotherapy," continued Soon-Shiong. "As the historical survival rate for third- to sixth-line pancreatic cancer patients is approximately two months, we are encouraged by this early data and have decided to open this cohort to more patients with advanced metastatic disease who have no further treatment options."

QUILT-88 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 (NCT04390399). Each treatment setting, as well as each first- and second-line or later maintenance treatment, will be evaluated independently as Cohorts A, B, and 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) per RECIST V1.1, and the objective of Cohort C is overall survival (OS). 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).

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 serves patients in the tri-state area (Iowa, Nebraska and South Dakota).