On October 17, 2022 CEL-SCI Corporation (NYSE American: CVM) reported the availability to the public of an oral presentation delivered by Dr. Philip Lavin of groundbreaking tumor response and increased overall survival in head and neck cancer (Press release, Cel-Sci, OCT 17, 2022, View Source [SID1234622081]). This presentation includes data presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress on September 10, 2022 in Paris, France. The ESMO (Free ESMO Whitepaper) poster presentation was titled "Early response to Neoadjuvant Leukocyte Interleukin Injection (LI) immunotherapy extends overall survival (OS) in locally advanced primary squamous cell carcinoma (SCC) of the head & neck (HN): the IT-MATTERS Study (Clinicaltrials.gov NCT01265849)."
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The summary of the most recent data presented from this Phase 3 clinical trial is that a 3-week administration of CEL-SCI’s investigational Multikine* (LI) treatment achieved groundbreaking tumor response and increased overall survival in treatment naïve locally advanced primary head and neck cancer patients who are scheduled to receive surgery and radiotherapy as their indicated treatment.
The study had 45 early tumor responses, including 5 complete and 40 partial responses; all were early tumor responses in that they followed a three-week Multikine treatment, were observed at surgery and occurred before radiotherapy. Early tumor response to Multikine treatment was both prognostic and predictive of overall survival. The Multikine tumor response was differentiating in that it was observed within a week after completion of the fixed 3-week Multikine treatment. The degree of response had a significant impact on subsequent survival, which qualifies Multikine early tumor response as a surrogate marker.
CEL-SCI strongly recommends that readers listen to the oral presentation at View Source
Dr. Lavin is a well-known biostatistician with a long history of supporting clinical trials for product registrations, reimbursements, and public health advancement. He has served on the faculty of Harvard Medical School at the Harvard School of Public Health for over 25 years and has been in the oncology field since 1974. Dr. Lavin also advised the FDA from 1983 through 2015 on product approvals and public policy matters as a Special Government Employee.
CEL-SCI’s 928-patient Phase 3 IT-MATTERS study was designed to determine if Multikine provided survival and other clinical benefits to patients suffering from locally advanced primary squamous cell carcinoma of the head and neck (SCCHN), oral cavity and soft-palate. Multikine is a mixture of naturally occurring cytokines that regulate the immune system. It is the first investigational cancer immunotherapy being developed as a first-line neo-adjuvant treatment to be provided to previously untreated locally advanced disease SCCHN patients before they receive the current standard of care (SOC), which is either surgery plus radiotherapy or surgery plus radio-chemotherapy. IT-MATTERS was conducted in 23 countries. CEL-SCI is preparing to submit a Biologics License Application (BLA) for marketing approval with the U.S. Food and Drug Administration (FDA) for Multikine.
The presentation available at the LINK includes the following:
5 patients were complete responders, with surgical confirmation of clearing all signs of cancer in the oral cavity, and 40 patients were partial responders to Multikine after 3 weeks of Multikine treatment, prior to any SOC treatment. Complete early tumor responses have not ever been reported in the scientific literature for locally advanced primary head and neck cancer according to medical experts.
The presentation delivered by Dr. Lavin included images of two patients who had a complete early response to treatment with Multikine within 5 weeks and prior to the standard of care surgery and radiotherapy and anonymized patient profiles for all the 5 complete responders. Images clearly show tumors in the patients’ oral cavity prior to treatment with Multikine and the disappearance of these tumors before surgery.