Phase 2 trial to assess natural killer cell therapy regimen for advanced pancreatic cancer
NantKwest and ImmunityBio have partnered on a phase 2 trial to examine the efficacy and safety of a chemoimmunotherapy regimen for treatment of metastatic or locally advanced pancreatic cancer.
The study is expected to open this month and has been approved by the FDA, according to a press release issued by the companies.
The randomized, two cohort, open-label QUILT-88 trial will evaluate a treatment regimen including PD-L1 tumor-targeted natural killer cells (PD-L1 t-haNK, NantKwest), the interleukin-15 superagonist N-803 (ImmunityBio) and standard-of-care chemotherapy compared with standard-of-care chemotherapy alone as first- and second-line treatment of locally advanced or metastatic pancreatic cancer.
“Our cell therapy candidate, PD-L1-t-haNK, is a novel natural killer cell-based immuno-oncology therapy that includes a PD-L1-based chimeric antigen receptor engineered into our proprietary haNK natural killer cell,” Patrick Soon-Shiong, MBBCh, MSS, FRCS(C), chairman and CEO of NantKwest and ImmunityBio, told Healio. “This targeted, next-generation therapy has been shown to significantly enhance cancer cell killing and improve overall response rates in preclinical studies and has the potential to target solid tumors.”
The companies have seen some success with the natural killer cell-based therapy for advanced Merkel cell carcinoma, both alone and in combination with N-803, as previously reported by Healio.
The investigational new drug application to the FDA was based on the “promising results” of a phase 1 trial, Soon-Shiong said. In that study, more than 130 doses of the natural killer cell therapy were given with no severe adverse events.
Four patients with metastatic pancreatic cancer were treated with PD-L1 t-haNK plus N-803 under single-patient INDs, he added. One patient had an ongoing complete response at 6-month follow-up, whereas another patient achieved stable disease.
The phase 2 trial will evaluate each treatment setting, and first- and second-line or later maintenance, independently as cohort A and cohort B, with separate experimental and control groups for each cohort. Researchers expect to enroll 268 patients across both cohorts.
The study’s primary objective will be comparative efficacy measured by PFS according to RECIST version 1.1. Secondary objectives comprise safety and additional efficacy measures, including ORR, complete response rate, durability of response, disease control rate and OS.
“Pancreatic cancer is a devastating disease and the fourth leading cause of cancer-related death,” Soon-Shiong told Healio. “Less than 5% of these patients will live for more than 5 years after diagnosis, and finding a suitable treatment is crucial for patients who have very few options.”