ImmunityBio Announces Phase 2 Results of Nant Cancer Vaccine in Third-Line Metastatic Pancreatic Cancer, Doubling Historical Survival with 6.3-Month Median Overall Survival
Jan 21, 2022 01:10
CST Updated
01:10
ImmunityBio
Developer of Immunotherapy Products
News on January 20, 2022 /BioValleyBIOON/ --ImmunityBio is a clinical-stage immunotherapy company. Recently, the company announced at the 2022 American ClinicalTumorNant Cancer Vaccine (Combined Immunotherapy) Phase 2 Trial Results in Third-Line Treatment of Metastatic Pancreatic Cancer (N=63) Presented at ASCO GI SymposiumClinical Trial(QUILT 88) Interim Results. The data show that in patients who have previously received two treatments,After receiving the Nant cancer vaccine treatment, the patient survival rate was twice the historical survival rate (Manax ASCO GI 2019).The data also showed a low incidence of treatment-related serious adverse events (8%), with no reports of treatment-related deaths. Based on these findings, ImmunityBio plans to collaborate with the United States in 2022.FDAMeeting to Discuss Pathways for Approving Combined Immunotherapy for Pancreatic Cancer
Pancreatic cancer is the fourth leading cause of cancer-related deaths in the United States and one of the cancers with the highest mortality rates among all major cancers, claiming nearly 50,000 lives annually in the U.S. Surgical intervention followed by adjuvant chemotherapy is currently the preferred treatment for pancreatic cancer, but the five-year survival rate for advanced-stage patients is only 3%. For most patients with more advanced disease, treatment typically involves either chemotherapy alone or supportive care for metastatic cases, and chemotherapy (with or without radiation) for locally advanced disease. Therefore, there is an urgent need for new therapies in this field.
Nant Cancer Vaccine Includes ImmunityBio’s IL-15 Receptor Agonist Anktiva (N-803), Off-the-Shelf Targeted Natural Killer Cells (PD-L1 t-haNK), Aldoxorubicin, and Low-Dose Chemotherapy.PD-L1 t-haNK Cells are Human-Derived Allogeneic NK Cell Lines Engineered to Express a Chimeric Antigen Receptor (CAR) Targeting PD-L1, Originating from NantKwest's Proprietary NK-92 (aNK) Master Cell Bank. In Addition to Targeting PD-L1, PD-L1 t-haNK is Also Engineered to Express a High-Affinity Variant of the CD16 Receptor (V158 FcγRIIIa), Which Mediates Antibody-Dependent Cellular Cytotoxicity (ADCC) by Attaching to Monoclonal Antibodies Previously Bound to Cancer Cells, Facilitating the Clearance of Cancer Cells.
In January 2021, ImmunityBio announced the early interim results of the PD-L1 t-haNK trial. The data showed that, without otherFDAIn patients with advanced metastatic pancreatic cancer who have approved treatment regimens, the median survival rate of those treated with the PD-L1 t-haNK combination therapy is twice the historical survival rate. These trials are based on the initial Cancer Moonshot hypothesis and the exploratory QUILT trial launched in 2017. The trial results appear to validate a theory:By coordinating NK cell and T cell therapies, survival rates can be improved without high-dose chemotherapy.
QUILT 88 is a randomized, three-cohort, open-label study (NCT04390399) designed to evaluate the safety and efficacy of the Nant cancer vaccine in treating locally advanced or metastatic pancreatic cancer. In the study, this combination Nant cancer vaccine is randomly compared with standard-of-care high-dose chemotherapy for first- and second-line treatment; the third-line or multiple-line cohort is a single group with an initial target of 50 patients, representing a highly advanced patient population who have experienced 2 to 6 prior treatment failures. The primary endpoint for this cohort is overall survival (OS).
As of now, 27% of patients (17/63) in the third-line or multi-line cohort remain in the study.In this group of highly advanced-stage patients, the median overall survival after receiving the Nant cancer vaccine was 5.8 months (95% CI: 3.9, 6.9 months), surpassing the historical median overall survival of approximately 3 months.Among these 63 patients, 30 (48%) had disease progression after two prior treatments. The median overall survival in this group was 6.3 months (95% CI: 5.0, 9.8 months), more than double the historical overall survival. Based on these early data and significant unmet medical needs, the company expanded the enrollment for the third-line or greater cohort.
Patrick Soon Shiong, M.D., founder and global chief scientific and medical officer of ImmunityBio, stated: "Patients with advanced pancreatic cancer have very few treatment options. Based on the encouraging data from the QUILT 88 trial, we hope that the Nant Cancer Vaccine will potentially address this significant unmet medical need. Additionally, we have designed this therapeutic candidate for outpatient treatment, which will enable patients to access the Nant Cancer Vaccine more easily in the future compared to traditional immune checkpoint inhibitors." (Bioon.com)