ImmunityBio Announces Results of Phase 2 Metastatic Pancreatic Cancer Trial at ASCO GI With Median Overall Survival of 6.3 Months in Patients With Third-Line Disease, More Than Doubling Historical Survival

ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, today announced interim results (N=63) in its metastatic pancreatic cancer trial (QUILT 88) showing that the overall survival rate for patients doubled compared to historical survival rate of three months after two prior lines of therapy (Manax ASCO GI 2019). The data of the Phase 2 trial studying a combination immunotherapy (Nant Cancer Vaccine) also show treatment-related serious adverse events were uncommon (8%) and no treatment-related deaths were reported. Based on these findings, ImmunityBio plans to meet with the FDA in 2022 to discuss the path for the approval of combination therapies for pancreatic cancer.

The results were presented today at the American Society of Clinical Oncology Gastrointestinal conference, which is being held virtually.

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, but 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, leaving patients seeking new options.

“There are thousands of patients in advanced stages of this disease and there are few, if any, treatment options for them,” said Patrick Soon-Shiong, M.D., Founder and Global Chief Scientific and Medical Officer of ImmunityBio, Inc. “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.”

To date, 27% of third-line or greater patients (17/63) remain on study. The median overall survival in this highly advanced group of patients, who failed two to six prior lines of treatment, is 5.8 months (95% CI: 3.9, 6.9 months) exceeding the approximately three-month historical median overall survival. Of the 63 patients, 30 (48%) had progressed after two prior lines of therapy. Median overall survival in this group was 6.3 months (95% CI: 5.0, 9.8 months), more than doubling the historical overall survival. On the strength of this early data and significant unmet medical need, the company has expanded enrollment in the third-line or greater cohort.