CEL-SCI Presents Head & Neck Cancer Data at Iddst Annual Congress in Budapest: Risk of Death Cut in Half for Patients Treated With Multikine in the Target Population

Rhea-AI Summary

CEL-SCI announced promising data for its investigational drug Multikine at the IDDST Annual Congress in Budapest. Dr. Eyal Talor presented findings showing that Multikine significantly improves overall survival in head and neck cancer patients with low PD-L1 expression levels. Specifically, the 5-year survival rate for Multikine-treated patients was 73%, compared to 45% in the control group. The hazard ratio was 0.35, indicating a 5-year death risk reduction from 55% to 27%. The company is planning a confirmatory FDA registration study.

Positive

• Multikine showed a statistically significant improvement in 5-year overall survival.
• 5-year survival rate for Multikine-treated patients was 73%, compared to 45% in the control arm.
• Hazard ratio of 0.35 indicates a 5-year death risk cut in half.
• The study involved 750 patients, providing extensive data on safety and efficacy.
• CEL-SCI is preparing for a confirmatory FDA registration study.

Negative

• Multikine's efficacy is to patients with low levels of tumor cell PD-L1 expression.
• The confirmatory FDA study is required, indicating that the drug is not yet approved for market use.
• There is uncertainty about the timeline and outcome of the FDA registration process.

Oncology Doctor

The data suggesting that Multikine significantly increases overall survival in patients with low levels of tumor cell PD-L1 expression is noteworthy. This finding is compelling because it contrasts with approved checkpoint inhibitors like Keytruda and Opdivo, which typically benefit patients with higher levels of PD-L1 expression. In simple terms, checkpoint inhibitors are drugs that help the immune system recognize and attack cancer cells but are generally more effective when the tumor has high PD-L1 levels. Multikine’s effectiveness in a different patient subset offers a new treatment avenue for those who might not have responded well to existing therapies. From a clinical perspective, this could potentially alter the treatment landscape for head and neck cancer, providing an alternative for a previously underserved group. The reduction in the 5-year risk of death from 55% to 27% is particularly impressive and speaks to the drug's potential efficacy.

Rating: 1

Medical Research Analyst

The reported hazard ratio of 0.35 in the Phase 3 trial for Multikine is a strong indicator of its potential efficacy. A hazard ratio below 1 suggests a reduction in the risk of death for the treatment group compared to the control group. In this context, a hazard ratio of 0.35 implies that the risk of death is reduced by 65%, a substantial improvement. Additionally, a log rank p-value of 0.0015 indicates that the survival difference is statistically significant, meaning it is highly unlikely to be due to chance. The next step involving a confirmatory registration study with the FDA will be critical. If these findings are replicated, it could pave the way for FDA approval, making Multikine a new standard of care in this patient population. This trial phase often scrutinizes safety and broader efficacy, so upcoming data will be important in further evaluating Multikine's viability.

Rating: 1

Market Research Analyst

The financial implications of these clinical results could be significant for CEL-SCI Corporation. Positive phase 3 trial results often lead to increased investor confidence, which can boost stock prices. The fact that Multikine targets a different subset of patients compared to existing checkpoint inhibitors means less direct competition and potentially a niche market with high unmet medical needs. However, it's essential to remain cautious until the confirmatory FDA registration study is completed, as approval hinges on these results. If successful, the company could see substantial revenue growth, driven by patient adoption and insurance reimbursements. The results reported so far will likely attract attention from both investors and potential partners or acquirers, looking to capitalize on this new therapeutic avenue in oncology.

Rating: 1

• Multikine significantly increases overall survival in patients with low levels of tumor cell PD-L1 expression in contrast to approved checkpoint inhibitors
• 73% survival for Multikine vs 45% in the control arm at 5 years
• Statistically significant log rank p = 0.0015
• 5-year risk of death cut in half from 55% to 27%
• Hazard ratio = 0.35 (95% CIs [0.19, 0.66])
• Working to commence FDA confirmatory Registration Study for Multikine

VIENNA, Va.--(BUSINESS WIRE)-- CEL-SCI Corporation (NYSE American: CVM) today announced the Company’s Chief Scientific Officer, Dr. Eyal Talor, delivered a presentation titled “Neoadjuvant Immunotherapy for Head and Neck Cancer: Low Tumor PD-L1 Expression - IT-MATTERS – RCT” at the International Drug Discovery Science & Technology (IDDST) 20th Annual Congress in Budapest, Hungary on Tuesday, June 18, 2024. Dr. Talor presented during the Cancers/Tumors session which he Chaired along with Dr. Elizabeth Tran of Purdue University.

(Graphic: Business Wire)

Multikine* (Leukocyte Interleukin, Injection) is the first investigational pre-surgical cancer drug intended for use in newly diagnosed locally advanced resectable head and neck cancer. There is extensive affirmative safety and efficacy data from 750 patients who have been treated with Multikine. A randomized, controlled, Phase 3 trial (RCT) in head and neck cancer revealed that Multikine significantly increases overall survival in patients with low levels of tumor cell PD-L1 expression in contrast to checkpoint inhibitors (e.g. Keytruda, Opdivo) which show longer survival benefit in patients with a higher level of tumor cell PD-L1 expression. Tumor cell PD-L1, also known as Programmed Death-Ligand 1, is a protein that plays a crucial role in immune system regulation. It is the target pathway for immune checkpoint inhibitors, a major class of immune-oncology drugs which work by blocking the interaction between tumor cell PD-L1 and the PD-1 receptor on immune effector cells, thereby favoring immune evasion by the tumor.

“The survival benefit of Multikine we observed from previous data for the same study population is much higher than that which will be required to be successful in the confirmatory study,” stated Dr. Talor.

The presentation may be accessed on CEL-SCI’s website at the following:

https://cel-sci.com/wp-content/uploads/2024/06/Scientific_Presentation_June-2024-Final.pdf

About CEL-SCI Corporation

CEL-SCI believes that boosting a patient’s immune system while it is still intact should provide the greatest possible impact on survival. Multikine is designed to help the immune system "target" the tumor at a time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor.

Multikine (Leukocyte Interleukin, Injection), a true first-line cancer therapy, has been dosed in over 750 patients and received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck. Multikine significantly extended life in its target patient population demonstrating a 73% survival rate with Multikine treatment regimen plus standard of Care (SOC) vs. only 45% for SOC without Multikine, at 5 years after treatment, Kaplan-Meier life table log rank p-value 0.0015. Based on this very strong data, the FDA concurred with CEL-SCI’s target patient selection criteria and gave the go-ahead to conduct a smaller, focused, confirmatory Registration Study of 212 patients. CEL-SCI will enroll newly diagnosed treatment naïve locally advanced primary SCC of the head and neck (oral cavity) cancer patients with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy). Globally, there are approximately 100,000 patients meeting these diagnostic criteria annually.

The Company has operations in Vienna, Virginia, and near/in Baltimore, Maryland.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, the words "intends," "believes," "anticipated," "plans" and "expects," and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI's filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K for the year ended September 30, 2023. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

* Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy. This proprietary name is subject to FDA review in connection with the Company's future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240618624058/en/

Gavin de Windt

CEL-SCI Corporation

(703) 506-9460

Source: CEL-SCI Corporation

FAQ

What is the significance of CEL-SCI's Multikine in head and neck cancer treatment?

Multikine significantly increases overall survival rates in patients with low levels of tumor cell PD-L1 expression, showing a 73% survival rate at 5 years vs. 45% in the control arm.

What were the main findings presented by CEL-SCI at the IDDST Congress?

CEL-SCI presented data showing that Multikine reduces the 5-year risk of death by half in head and neck cancer patients with low PD-L1 levels.

What is the hazard ratio for Multikine in CEL-SCI's study?

The hazard ratio for Multikine was 0.35, indicating a significant reduction in the risk of death over 5 years.

When was CEL-SCI's presentation on Multikine delivered?

The presentation was delivered on June 18, 2024, at the IDDST 20th Annual Congress in Budapest.

What is the next step for CEL-SCI following the Multikine study results?

CEL-SCI is planning to commence a confirmatory FDA registration study for Multikine.