ASCO 2022: Phase III IT-MATTERS study Highlights

CEL-SCI’s leukocyte interleukin injection, an immunity booster for patients with Head and Neck squamous cell carcinoma!

Multikine is CEL-SCI’s lead investigational immunotherapy product being developed as a potential first-line neoadjuvant therapy in patients with advanced primary squamous cell carcinoma of the head and neck. The company presented the results of its IT-MATTERS Phase III study at the ASCO 2022 annual meeting. This Phase III study evaluated whether leukocyte interleukin (LI) administered in combination with cyclophosphamide, indomethacin, and zinc (CIZ) in a multivitamin combination before the standard of care therapy (surgery followed by radiotherapy or concurrent radio chemotherapy) is safe and will increase the overall survival of subjects with previously untreated squamous cell carcinoma of the oral cavity or soft palate at a median of 3 years or not.

According to the presented results, differences in the safety results were not very much significant in the treatment groups. The Leukocyte Interleukin (LI), as neoadjuvant therapy, was not seen to add any additional safety concerns or raise any treatment-emergent adverse events (TEAEs). In the intent to treat population (ITT), IL treatment was observed to be helpful in decreasing mortality and was seen as prognostic/predictive of the overall survival (OS). 14% absolute OS benefit was seen in the lower-risk treatment cohort.

This IT-MATTERS Phase III study has shown the effect on the OS in the advanced primary squamous cell carcinoma of head and neck lower-risk patients.  Such results are claimed to be the first in a randomized study in the past 25+ years. Based on this pivotal Phase III study results, CEL-SCI is looking forward to filing a Biologic License Application with the US Food and Drug Administration (FDA) for approval of this indication.

KOL insights:

“Multikine has shown some significant results, specifically for the low-risk patients. This category of patients represents the unmet patient population. Non-toxic effects and better OS are very important for analyzing any drug for the patients, and Multikine has shown good results for both of them. We can expect a change in the standard of care if BLA for Multikine is approved by the FDA.”– Expert Opinion.


Multikine is a leukocyte interleukin injection being developed by CEL-SCI Corporation and is a first-in-line product focusing on neoadjuvant settings. Results from the Phase III study, IT-MATTERS, have shown results consistent with those of Phase II and also that the drug was able to provide good survival benefits to patients and at the same time was found to have no additional safety issues. The effect of this drug on the OS of the lower-risk advanced primary SCCHN patients is seen as the first in any of the randomized clinical trials in the past 25 years. Based on the IT-MATTERS study results, CEL-SCI intends to file a Biologic License Application (BLA) with the US FDA for the approval of this therapy.

Previously in a 9.5-year pivotal Phase III study of Multikine, the drug missed its primary endpoint because it was able to show great survival benefits in the first treatment arm (surgery plus radiation), but the same did not happen with the second arm.

Multikine, if it continues to perform well in future trials, might emerge as an effective immunity booster in the HNSCC treatment space with the capability to change SOC. If approved, this therapy is expected to change the standard of care (SOC) being followed for patients with advanced primary head and neck cancer.