Leukocyte interleukin injection improved OS in patients with oral cancer expressing low tumor PD-L1 levels.
Leukocyte interleukin injection (Multikine) displayed an overall survival (OS) benefit compared with standard-of-care (SOC) treatment in patients with oral cancer expressing low tumor PD-L1 levels, according to data from the phase 3 IT-MATTERS trial (NCT01265849).1
Findings from the study demonstrated that the 5-year OS rate among patients with newly diagnosed, previously untreated, resectable, locally advanced head and neck cancer with low tumor PD-L1 expression and no lymph node involvement who received leukocyte interleukin injection prior to SOC was 73% compared with 45% in patients who received SOC alone. The risk of death was reduced from 55% to 27%. A manuscript detailing findings from IT-MATTERS trial has been accepted for publication in Oral Oncology.
"The acceptance of this manuscript by Oral Oncology represents another important validation of the quality and significance of our clinical data," Geert Kersten, chief executive officer of CEL-SCI, stated in a news release. "Publication in leading peer-reviewed journals expands awareness of [leukocyte interleukin injection] among oncologists, head and neck surgeons and cancer researchers around the world. As we prepare to begin patient enrollment in our confirmatory registration study, we believe growing recognition within the scientific community will further strengthen the foundation supporting [leukocyte interleukin injection’s] potential to become an important new treatment option for patients with low PD-L1 head and neck cancer."
Unlike currently available immune checkpoint inhibitors, which are directed primarily at patients with higher PD-L1 expression, leukocyte interleukin injection is being developed specifically for those with low PD-L1 tumor expression. The agent is administered immediately after diagnosis and before surgery, radiation, or chemotherapy, with the intent of activating antitumor immunity before conventional treatment weakens the immune system.
Leukocyte interleukin injection has been dosed in more than 740 patients across its clinical development program and holds FDA Orphan Drug designation for the neoadjuvant treatment of squamous cell carcinoma of the head and neck.
IT-MATTERS was an open-label, randomized, multicenter controlled study that enrolled patients with advanced primary squamous cell carcinoma of the oral cavity.2 Patients were required to be at least 18 years old, have a life expectancy of greater than 6 months, have normal immune function, have no immunosuppression within 1 year of entry, and a Karnofsky Performance Status of greater than 70/100.
In the investigational arm, patients received leukocyte interleukin injection as neoadjuvant therapy prior to SOC. In the control arm, patients received SOC alone; SOC consisted of cisplatin and radiotherapy. Patients in both arms underwent surgery.
The primary end points were OS and OS in low-risk patients. Secondary end points included local regional control, local regional control in low-risk patients, progression-free survival (PFS), PFS in low-risk patients, and quality of life measures.
CEL-SCI said it is preparing to begin enrollment in its global, approximately 212-patient confirmatory registration study, which is designed to confirm the OS benefit observed in the predefined target population from the completed phase 3 trial.¹ The study is planned to enroll patients at clinical centers across the United States, Europe, and Asia and is powered at approximately 97% to detect the previously observed OS HR of 0.34 in the same selected population.
