On September 12, 2022 CEL-SCI Corporation (NYSE American: CVM) reported two poster presentations were delivered at the European Society for Medical Oncology (EMSO) annual Congress on September 10, 2022 in Paris, France (Press release, Cel-Sci, SEP 12, 2022, View Source [SID1234619458]). Data presented were from the Company’s pivotal Phase 3 study, the largest study ever conducted in newly diagnosed locally advanced squamous cell carcinoma of the head and neck.
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Poster Presentation: 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)
Summary of findings presented by Dr. Philip Lavin:
Early tumor response (early response) to neoadjuvant Multikine-Treatment is noted before surgery (occurring at median 5 weeks post-randomization) adding credibility to the isolated impact of early treatment
Early response provides a positive signal to both patients and care providers (early in the treatment course)
Early response was noted only in the Multikine* (Leukocyte Interleukin Injection) treatment groups and not in the control group
Early response occurs in both the Lower Risk and Higher Risk groups for recurrence (Risk as defined per NCCN Guidelines)
Early response is prognostic and predictive for overall survival in:
The overall population; and
The Lower Risk population
Benefit was also seen in Multikine-treated Lower Risk non-responders
Dr. Lavin commented, "The IT-MATTERS study is groundbreaking by having achieved 45 RECIST documented neoadjuvant responses including 5 complete responses confirmed at surgery by pathology. All responses were limited to the Multikine treatment groups, which is a 1 in 100 billion chance event. Response mattered; the overall survival was >3x longer for responders vs non-responders."
Dr. Lavin is a well-known biostatistician with a long history supporting clinical trials for product registrations, reimbursements, and public health advancement. He has served as the Lead Biostatistician for 80 FDA approvals including 43 PMAs, 23 NDAs, 8 510Ks, 4 BLAs, and 2 de novos with more pending. These approvals have resulted in >$25B in increased valuations. Dr. Lavin also advised the FDA from 1983 through 2015 on product approvals and public policy matters as a Special Government Employee.
Poster Presentation: Histopathology (HP) biomarkers confirm Leukocyte Interleukin Injection (LI) treatment (Tx) outcome in naïve locally advanced primary head & neck squamous cell carcinoma (SCCHN) the IT-MATTERS Study (Clinicaltrials.gov NCT01265849)
Summary of findings presented by Dr. József Tímár:
Pre-defined markers, ratios, and combinations derived from Multikine treated tumor samples at surgery contribute to Multikine efficacy for all three efficacy endpoints (OS), progression free survival (PFS), and local regional control (LRC)
Broad representation of markers, ratios, and combinations overall and for Lower Risk (LR) for the OS, PFS, LRC efficacy study endpoints
There were 61 (21.9%) favorable overall and 54 (19.4%) favorable Lower Risk treatment group outcomes (much beyond 2.5% chance) and only a total of five instances (1.9%) [all High Risk] having unfavorable treatment group outcome (within the realm of chance)
These biomarkers were prognostic for superior efficacy of the post surgery adjuvant radiotherapy as compared to adjuvant chemoradiotherapy
The results support the Lower Risk treatment advantage (0.68 HR, Wald p<0.05) significantly favoring Multikine+CIZ+ SOC vs SOC alone
Dr. Timar stated, "Biomarker analysis indicated that low expression of tumor cell PDL1, high density of most of the immune cell types (CD4, CD8, T cells, B cells, macrophages), high CD4/CD8 and low CD8/FOXP3 ratios as well as high density of CTLA4 and CD25 positive cells, were all predictive of Multikine efficacy in the Multikine treated population."
József Tímár MD, PhD, DSc, is a prominent and highly respected pathologist. He is Professor Department of Pathology, Forensic and Insurance Medicine at Semmelweis University in Budapest, Hungary, and served as the Director of the Central Pathology Laboratory for the IT-MATTERS study. With 174 peer reviewed studies published, Dr. Timar is a founding editor, editor in chief, or a member of the editorial board of four oncology journals. He is the recipient of a dozen honors and awards for excellence in cancer research and teaching.