Data from the phase 2 QUILT-88 study were presented at the 2022 ASCO GI symposium.
The novel combination of aldoxorubicin, N-803 IL-15 superagonist, and PDL1- natural killer (NK) cell therapy after chemo-radiation has shown efficacy as third-line or greater treatment in patients with metastatic or locally advanced pancreatic cancer.1
Data from the phase 2 QUILT-88 study (NCT04390399) assessing the combination therapy, dubbed the Nant Cancer Vaccine (ImmunityBio), was presented at the 2022 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers (GI) Symposium, January 20-22, 2022, by Tara Seery, MD, oncologist, Hoag Memorial Hospital.
“Pancreatic cancer claimed an estimated 47,050 lives in the USA in 2020, with an expected median overall survival (OS) of 3 months in 3rd line... with no evidence of disease control in these late-stage patients. We hypothesize that effective response against pancreatic cancer requires orchestration of both the innate and adaptive immune system to accomplish immunogenic cell death with survival benefit,” Hoag and colleagues wrote.1
The QUILT-88 study has treated 55 participants with low dose, chemo radiation nab-paclitaxel (100 mg/m2 IV), gemcitabine (600 mg/m2 IV), cyclophosphamide (50 mg PO BID) and low dose SBRT followed by the combination of aldoxorubicin (150 mg/m2 IV), N-803, (15 μg/kg SC) and PD-L1 t-haNK (̃2 × 109 cells/dose IV).
As of data cut-off, participants have been followed-up for a median of 3.9 months. Participants are a median age of 62 years with a male to female ratio of 35:20. Most participants (92%) have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. In terms of safety, 75% (n = 41) experienced at least a grade 3 adverse event related to chemo. These included anemia (44%), neutropenia (24%), thrombocytopenia (11%), and others. Few patients (9%; n = 5) experienced serious AEs. No treatment-related deaths have occurred.
In terms of efficacy, investigators found that overall survival (OS) was 81.8% (n = 36; 95% CI, 67.3-91.8) in the 44 evaluable patients at 3-month follow-up, which is more than double the historical median OS in patients who had progressed after 2 prior lines of therapy.2 Disease control rate was 36.2% (95% CI, 22.7-51.5) in 47 evaluable patients. Sixteen participants are continuing to receive treatment. The longest treatment duration to date is 14 months. Median OS is not yet able to be assessed. The median progression-free survival is 2.4 months (95% CI, 2.0-3.7) and 36% of participants have not progressed to date.
“There are thousands of patients in advanced stages of this disease and there are few, if any, treatment options for them,”Patrick Soon-Shiong, MD, founder and global chief scientific and medical officer, ImmunityBio, said in a statement.2“Based on this encouraging data from our QUILT 88 trial, we are hopeful that our Nant Cancer Vaccine can potentially address this unmet need. What’s more, we designed this therapeutic candidate to be administered in an outpatient setting making it more accessible to future patients than traditional immune checkpoint inhibitors.”
ImmunityBio plans to meet with the FDA in 2022 to discuss the pathway to approval for the Nant Cancer Vaccine.