CEL-SCI's revolutionary advances are impressive; their data shows that overall survival increased by almost 4 years, and some tumors even dissipated after a mere three weeks of Multikine therapy. The passionate group at CEL-SCI is completing the necessary confirmations for their manufacturing plant with efficiency while collaborating closely with the FDA to submit a BLA. It appears they are on the brink of presenting their application and obtaining expedited review from the FDA - taking them one step closer to revolutionizing healthcare.

CEL-SCI Presents New Data from Multikine Phase
CEL-SCI Presents New Data from Multikine Phase 3 Clinical Trial Pixabay

We first explored CEL-SCI in a 2020 story titled A Biotech Giant Patiently Waits: CEL-SCI, Multikine, and the Future Ahead.

Attending the 10th European Congress on Head & Neck Oncology in March 2023, CEL-SCI proudly announced that their Multikine Phase 3 Cancer Study showed a 43% increase in patient survival. This encouraging revelation was backed up by six different efficacy measures which demonstrated how adding Multikine to standard treatment for cancer patients can yield long overdue advantages after too many decades of no new therapy options.

CEL-SCI Corporation (NYSE American: CVM) recently shared the findings from its landmark Phase 3 study, which is now regarded as the largest ever conducted in relation to newly diagnosed cases of locally advanced squamous cell carcinoma of the head and neck (SCCHN).

On March 8th, 2023 at the 10th European Congress on Head & Neck Oncology (ECHNO) in Lisbon, Portugal, Eyal Talor Ph.D., CEL-SCI's Chief Scientific Officer gave a riveting poster presentation entitled "Leukocyte Interleukin Injection (LI) immunotherapy followed by radiotherapy extends overall survival (OS) in treatment naïve locally advanced primary squamous cell carcinoma of the head & neck: The IT-MATTERS Study".

With the goal of gaining FDA and other global regulatory agency approval, CEL-SCI is planning to submit a Biologics License Application (BLA) for Multikine®* (Leukocyte Interleukin, Injection) to treat newly diagnosed SCCHN in lower risk patients. According to NCCN guidelines, this patient population consists of around 210,000 cases globally every year.

The data presented is crucial due to its distinct focus on the patient population from IT-MATTERS (n=352). CEL-SCI aims for marketing approval of locally advanced primary head and neck cancer patients who are set to receive radiotherapy without chemotherapy after surgery.

According to the NCCN guidelines, Low Risk (LR) patients typically receive radiotherapy as their sole post-operative treatment. On the other hand, those with a higher risk of recurrence are prescribed concurrent chemoradiotherapy - that is chemotherapy given at the same time as radiation therapy immediately after surgery.

The IT-MATTERS study assessed 44 patients who had a potential for recurrence after surgery but only received radiotherapy instead of the recommended chemoradiotherapy. These higher risk individuals were accounted for in the initial survival assessment conducted by the IT-MATTERS study.

By excluding the 44 patients from the analysis, CEL-SCI have been able to gain a better understanding of Multikine's impact on long-term patient survival. In fact, at ECHNO 2023 Congress, CEL-SCI's presentation shows evidence that demonstrates those who used Multikine post-surgery lived significantly longer than control participants (n=352) who only underwent radiation therapy.

After studying the intended patient population who had undergone surgery and were following National Comprehensive Cancer Network (NCCN) guidelines for radiotherapy, CEL-SCI observed noteworthy outcomes. Specifically:

  1. Over time, the survival benefit of adding Multikine+CIZ to the treatment regimen skyrocketed compared to Standard of Care (SOC) alone. This advantage increased from 2.8% at 3 years (36 months), to 8.3% at 4 years (48 months), and eventually up to 15.6 % after 5 full years(60 months). After five long-term trials, it was observed that control groups had a 49.7 % survival rate while those receiving Multikine treatments achieved an impressive 65.3%.
  2. The hazard ratio of 0.70 signified a 43% extended survival rate (95% CI: [0.49 - 1.00]), demonstrating the efficacy and potential of this particular treatment option.
  3. After five years, the progression-free survival rate of those treated with Multikine +CIZ + SOC was 8.4% higher than that of individuals who only received SOC control treatments alone.
  4. Following 3 weeks of Multikine treatment, nearly one-sixth (16.5%) of patients proved to be early tumor responders - including complete responders after subsequent pathologic confirmation - compared with no responder in the group treated exclusively by standard-of-care protocol.
  5. The Multikine patients who had an early response to their tumors demonstrated remarkable improvement in survival rates, with only a 15.6% death rate compared to the 48.7% mortality of those who did not receive treatment.
  6. Even though there wasn't an early tumor response for some of the patients, their overall survival rate was still much better than that of those in the control group; 43.8% death rate compared to 48.7%.

CEL-SCI CEO Commentary on Latest Data Presentation

"Our pivotal study, the largest ever of its kind in head and neck cancer, continues to produce impressive data that demonstrate Multikine's ability to improve outcomes and extend survival for newly diagnosed patients who have not had the benefit of a new treatment in decades," stated CEL-SCI CEO, Geert Kersten.

"These data are presented at the world's leading scientific peer-reviewed conferences, underscoring Multikine's potential as we work toward an FDA marketing approval submission."

Geert Kersten was recently honored by Life Sciences Voice as one of their Top Industry Leaders, due to his pioneering efforts and substantial contributions to the field. This impressive list of leaders includes executives from renowned companies like Novartis, Biogen, AbbVie and Merck among many others.

About CEL-SCI Corporation

CEL-SCI Corporation is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative immunotherapy products. Their lead compound, Multikine (Leukocyte Interleukin Injection or LIL), is being developed to treat newly diagnosed head and neck cancer patients prior to any definitive treatment. Its advanced clinical trials have been consistently producing promising results, with the ultimate goal of improving cancer treatment outcomes for patients around the world.

The IT-MATTERS Study

The IT-MATTERS study (Intergroup Trial for Multikine Plus Cisplatin and 5-Fluorouracil in Advanced Metastatic Squamous Cell Carcinoma) is a randomized, double-blind Phase 3 clinical trial evaluating the efficacy of Multikine+CIZ+SOC (cisplatin and 5-fluorouracil) versus SOC alone in the treatment of advanced metastatic squamous cell carcinoma.

The results from this trial could provide support for marketing authorization of Multikine as a first-line treatment in advanced metastatic squamous cell carcinoma. This could be an important breakthrough in the treatment of cancer, and may improve survival rates and quality of life for patients around the world.

Consequently, for the Phase 3 study, CEL-SCI tested out Multikine on individuals newly identified with locally advanced primary squamous cell carcinoma of the head and neck before they received treatment such as surgery plus concurrent radiotherapy and chemotherapy (the generally accepted approach to treating these patients).

CEL-SCI has pioneered a one-of-a-kind cancer immunotherapy method. Unlike other therapies, Multikine (Leukocyte Interleukin, Injection) is dispensed even before conventional treatments are applied or unsuccessful. The FDA recognized this approach and granted it Orphan Drug status for neoadjuvant therapy in individuals with head and neck squamous cell carcinoma. As far as the company knows, their Phase 3 study is the largest of its kind worldwide to treat primary locally advanced head and neck cancer cases.

About Multikine

Multikine (Leukocyte Interleukin Injection, or LIL) is a complex mixture of over 10 cytokines, or immune system-regulating proteins. This unique blend of cytokines has the potential to create an immuno-stimulatory effect on the body's natural defenses and help fight cancer cells. It was developed specifically for use as a neoadjuvant therapy in individuals with newly diagnosed primary head and neck cancer.

The FDA has granted Multikine an Orphan Drug designation, which is reserved for treatments that are intended to treat rare diseases or conditions. This status provides incentives to the company to continue its work on developing this groundbreaking treatment in order to bring it to market.

CEL-SCI is motivated to make a difference in the fight against cancer and is dedicated to researching cutting edge therapies that could revolutionize treatment for individuals everywhere. Already, their IT-MATTERS clinical trial has made an impact with its results, demonstrating how the company's dedication offers hope of a brighter future in healthcare. By embracing innovation within treatments and cures, CEL-SCI is paving the way towards transforming how we treat cancer across the globe.

CEL-SCI has registered the trade name Multikine (Leukocyte Interleukin, Injection) for their investigational therapy. Despite this title being under evaluation by the FDA with respect to its potential approval, Multikine hasn't been approved yet and is still unverified in regards to its safety and effectiveness from any use.

CEL-SCI's innovative immunotherapy, Multikine, is designed to activate the immune system in its highest functioning condition and fight cancerous tumors. Phase 3 trials for this remarkable therapy began in 2011 with an impressive 928 participants; by September 2016 enrollment was completed as planned.

To prove that this therapy is effective in prolonging life, 298 deaths should be measured between two comparison groups. CEL-SCI has established its headquarters in Vienna, Virginia and subsidiaries near/in Baltimore, Maryland - taking steps towards revolutionizing the healthcare landscape by pushing their research goals. They are setting a new precedent worldwide for health care treatments.

In Closing

CEL-SCI is making strides in the fight against cancer by pioneering a one-of-a-kind immunotherapy method. Multikine (Leukocyte Interleukin, Injection) has received Orphan Drug status from the FDA and Phase 3 trials began in 2011 with an impressive 928 participants.

CEL-SCI is dedicated to researching cutting edge therapies that could revolutionize treatment for individuals everywhere and prove that their therapy is effective in prolonging life. They are setting a new precedent worldwide for health care treatments and offer hope of a brighter future in healthcare.