On June 7, 2022 CEL-SCI Corporation (NYSE American: CVM) reported that its abstract and poster titled "Leukocyte interleukin injection (LI) immunotherapy extends overall survival (OS) in treatment-naive low-risk (LR) locally advanced primary squamous cell carcinoma of the head and neck: The IT-MATTERS study" was presented on June 6, 2022 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s 2022 ASCO (Free ASCO Whitepaper) Annual Meeting in Chicago, Illinois (Press release, Cel-Sci, JUN 7, 2022, View Source [SID1234615715]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Presented by CEL-SCI’s Chief Scientific Officer, Eyal Talor, Ph.D., to the largest gathering of cancer experts from academia, industry, patient advocacy and policy, the poster provided detailed data on Multikine’s (Leukocyte Interleukin, Inj.)* efficacy in extending overall survival in treatment-naive low-risk (LR) locally advanced primary squamous cell carcinoma of the head and neck. The abstract was selected by ASCO (Free ASCO Whitepaper) for poster presentation and was well received by oncology experts at the conference.
Based on the results of this pivotal Phase 3 study, including data in the ASCO (Free ASCO Whitepaper) poster presentation, CEL-SCI intends to file a Biologic License Application with the U.S. Food and Drug Administration (FDA) for approval of this indication.
Link to poster: View Source
Link to ASCO (Free ASCO Whitepaper) abstract 6032: View Source
The conclusions presented in the poster are as follows:
Safety results were not significantly different between treatment groups.
Leukocyte Interleukin, LI (MK) neoadjuvant immunotherapy did not add excess safety issues or TEAEs.
In the Randomized ITT population, early LI (MK) response decreases mortality and is prognostic/predictive of OS.
ITT Lower Risk LI (MK)+CIZ+SOC absolute OS advantage over SOC alone (Control) increased over time to 14.1% at 5-years; the 0.68 HR corresponds to a 47% prolongation of median survival, having a 46-month median OS advantage over SOC alone. The SCCHN population studied has been without any new therapy options in decades.