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Cel-Sci To Present Abstract at 2022 ASCO Annual Meeting Regarding Multikine Study

As a part of the ASCO Annual Meeting that is going to be held between 3rd – 7th June 2022, Dr. Eyal Talor is going to present their abstract publication on the behalf of their team this time. 

Eyal Talor, Ph.D.is a part of the CEL-SCI Corporation in Vienna, VA. They are known for their research-related expertise in the disciplines that revolve around biotechnology, immunology, and oncology. Most recently the team completed a pivotal Phase 3 Multikine® (Leukocyte Interleukin, Inj.) which is what the abstract and data presentation is expected to reflect.

This time as well, the abstract that awaits its audience at the ASCO Annual Meeting is from one such discipline, namely head and neck cancers.  

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Overview Of Abstract

Squamous cell carcinomas of the head and neck region are among the most common types of cancers that occur in this region. 

Approximately 90% of all cases of cancer are diagnosed as SCCHN. The incidence of these cancers is seen to have risen over time. 

Provided that the cure and survival rate of these cancers depends on how early they are diagnosed and treated, it is often seen that these cancers are diagnosed quite late in the course of their progression when only supportive treatment could be given to the patient to prolong their survival. 

The standard treatment protocol that is followed currently is the surgical excision of the tumor, which is followed by radiotherapy and chemotherapy to minimize the chances of any recurrences that might occur. 

However, the main goal of Cel-Sci is to devise treatment plans that could make it possible for the low-risk patients (N0 – N1 of the TNM staging) and those without any extracapsular spread to the cervical lymph nodes to get treated before undergoing surgery. 

The plan was to reflect on such approaches that could make it possible for these people to undergo treatment with Multikine before they went for surgery. 

It was decided that a 2-step exclusion algorithm should be designed. This algorithm will consist of two steps – one being the ‘N’ classification of the locally-advanced tumor and the other being the employment of imaging modalities (CT, MRI, PET-CT, PET-MRI) to detect the clinical features. 

In this way, it would become possible for the low-risk (N0 – N1) patients to get screened and excluded before they underwent any surgery. These patients could then benefit from the neoadjuvant immunotherapy protocol and experience the shrinkage or reduced progression of their tumor without having to face the extremities of invasive surgery first. 

Study Background

In a scientific study, the 3-week peritumoral administration of an investigational proinflammatory cytokine complex biologic (LI) with a low dose of cyclophosphamide, indomethacin, and Zinc to oral and soft-palate SCCHN patients resulted in an early response prior to surgery. It significantly prolonged OS in the NCCN-defined LR (low-risk) intent-to-treat population compared to SOC (Standard of Care) alone. Positive results from phase 2 OS and early responders prompted this important trial.

In this study, subjects were randomized 3:1:3 to treatment arms LI, which received 200IU peritumoral and the same dose peri-lymphatically every day for three weeks before surgery. Subjects with a low risk of recurrence were given RTx, while those with a high risk of recurrence were given CRTx after surgery.

This study reported that LI immunotherapy did not result in any additional safety concerns. Early LI response lowers mortality and is associated with a better overall prognosis. ITT LR LI+CIZ+SOC absolute OS advantage over SOC alone has grown over time.

Study Results

CEL-SCI’s Multikine immunotherapy has shown a significant 14.1% 5-year survival rate in patients who received surgery and radiotherapy, 62.7% compared to 48.6% in the control group. This is a landmark study of head and neck cancer patients that could change the way these cancers are treated in the future.

The findings show that there is a significant overall survival gain for patients who received the Multikine treatment strategy, followed by surgery and radiation therapy. The group with the significant survival advantage (no chemotherapy) makes up roughly 155,000 people each year worldwide, which is approximately 40% of the newly diagnosed advanced primary head and neck cancer patient cases.

The Multikine treatment regimen followed by surgery and radiation therapy (without chemotherapy) led to a statistically significant OS benefit compared to Standard of Care (SOC) alone.

The probability of surviving 3 years was 4.9% higher (72.4% vs 67.5%), and the 5-year survival advantage was 14.1% (62.7% vs 48.6%). The Multikine treatment regimen, which includes surgery and radiotherapy (but not chemotherapy), resulted in a consistent OS benefit, with a median follow-up time of more than 7 years for those still alive.

The company is currently working to gain FDA approval for Multikine immunotherapy based on significant OS benefits demonstrated in the study along with the favorable safety profile.

If approved, this would make Multikine this would make Multikine the first immunotherapy drug available to patients with head and neck cancer.

The study was conducted to evaluate whether CEL-SCI’s immune checkpoint therapy would help improve survival in advanced primary head and neck cancer. The positive outcomes of this group of patients, according to CEL-SCI, signify the first success of a neoadjuvant cancer immunotherapy in advanced primary head and neck cancer.

The analysis of the separate group is expected to meet regulatory requirements for FDA submission. This is an important milestone for CEL-SCI and provides hope to patients suffering from this aggressive form of cancer.

Cancer immunotherapy is an area of great interest in oncology research. This study provides strong evidence that neoadjuvant cancer immunotherapy can be an effective treatment for advanced primary head and neck cancer. The results of this study will help inform future research in this area and could potentially lead to new treatments for this aggressive form of cancer.

The group with the significant survival advantage (no chemotherapy) makes up roughly 155,000 people each year worldwide, which is approximately 40% of the newly diagnosed advanced primary head and neck cancer patient cases.

The Multikine treatment regimen followed by surgery and radiation therapy (without chemotherapy) led to a statistically significant OS benefit compared to Standard of Care (SOC) alone.

The probability of surviving 3 years was 4.9% higher (72.4% vs 67.5%), and the 5-year survival advantage was 14.1% (62.7% vs 48.6%). The Multikine treatment regimen, which includes surgery and radiotherapy (but not chemotherapy), resulted in a consistent OS benefit, with a median follow-up time of more than 7 years for those still alive.

CEL-SCI plans to seek FDA approval for Multikine immunotherapy based on the demonstrated significant OS benefit and favorable safety profile seen in unmet medical need for head and neck cancer patients who received Multikine, surgery, and radiotherapy as part of their standard of care (SOC). If approved, this would make Multikine this would make Multikine the first immunotherapy drug available to patients with head and neck cancer.

The study was conducted to evaluate whether CEL-SCI’s immune checkpoint therapy would help improve survival in advanced primary head and neck cancer. The positive outcomes of this group of patients, according to CEL-SCI, signify the first success of a neoadjuvant cancer immunotherapy in advanced primary head and neck cancer.

The analysis of the separate group is expected to meet regulatory requirements for FDA submission. This is an important milestone for CEL-SCI and provides hope to patients suffering from this aggressive form of cancer.

Cancer immunotherapy is an area of great interest in oncology research. This study provides strong evidence that neoadjuvant cancer immunotherapy can be an effective treatment for advanced primary head and neck cancer. The results of this study will help inform future research in this area and could potentially lead to new treatments for this aggressive form of cancer.

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