CEL-SCI’s Phase 3 Population Analysis for Upcoming Confirmatory Registration Study in Head & Neck Cancer Demonstrates Well Balanced Patient Population, Confidence in Clinical Results
CEL-SCI (NYSE American: CVM) reported positive results from a bias analysis for its Phase 3 study of Multikine in head and neck cancer treatment. The analysis showed no bias in the study, with comparable demographics and baseline characteristics between Multikine-treated and control arms. This supports the reliability of the study data, which demonstrated Multikine's efficacy in extending patient life.
Key findings include:
- 5-year survival rate of 73% in Multikine-treated patients vs. 45% in control group for the target population
- Hazard ratio of 0.35 with an upper limit of 0.66, suggesting a high chance of repeating the survival benefit
- No confounding baseline parameters detected
CEL-SCI is preparing to submit data to regulators for a 212-patient confirmatory registration study, agreed upon with the FDA.
CEL-SCI (NYSE American: CVM) ha riportato risultati positivi da un'analisi imparziale per il suo studio di Fase 3 su Multikine nel trattamento del cancro testa-collo. L'analisi ha mostrato nessun bias nello studio, con caratteristiche demografiche e parametri di base comparabili tra i gruppi trattati con Multikine e il gruppo di controllo. Questo supporta l'affidabilità dei dati dello studio, che ha dimostrato l'efficacia di Multikine nel prolungare la vita dei pazienti.
I principali risultati includono:
- tasso di sopravvivenza a 5 anni di 73% nei pazienti trattati con Multikine rispetto al 45% nel gruppo di controllo per la popolazione target
- rapporto di rischio di 0.35 con un limite superiore di 0.66, suggerendo un'elevata possibilità di ripetere il beneficio di sopravvivenza
- Nessun parametro di base confondente rilevato
CEL-SCI si sta preparando a presentare i dati alle autorità di regolamentazione per uno studio di registrazione confermativo su 212 pazienti, concordato con la FDA.
CEL-SCI (NYSE American: CVM) informó resultados positivos de un análisis imparcial para su estudio de Fase 3 sobre Multikine en el tratamiento del cáncer de cabeza y cuello. El análisis mostró sin sesgo en el estudio, con características demográficas y de base comparables entre los grupos tratados con Multikine y el grupo de control. Esto apoya la fiabilidad de los datos del estudio, que demostraron la eficacia de Multikine para extender la vida de los pacientes.
Los hallazgos clave incluyen:
- tasa de supervivencia a 5 años de 73% en pacientes tratados con Multikine frente al 45% del grupo de control para la población objetivo
- razón de riesgos de 0.35 con un límite superior de 0.66, lo que sugiere una alta probabilidad de repetir el beneficio en la supervivencia
- No se detectaron parámetros de base confusos
CEL-SCI se está preparando para presentar datos a los reguladores para un estudio de registro confirmatorio de 212 pacientes, acordado con la FDA.
CEL-SCI (NYSE American: CVM)는 Multikine의 두경부 암 치료를 위한 3상 연구의 편향 분석에서 긍정적인 결과를 보고했습니다. 분석 결과는 연구에서 편향이 없음을 보여주었으며, Multikine 치료 그룹과 대조군 간의 인구 통계학적 특성과 기초 특성이 유사했습니다. 이는 환자 생존 연장을 입증한 Multikine의 효능 데이터 신뢰성을 지원합니다.
주요 발견 사항은 다음과 같습니다:
- Multikine 치료 환자의 5년 생존율이 73%로 대조군의 45%에 비해 높습니다.
- 위험비가 0.35로 상한선이 0.66로 나타나 생존 혜택 재현의 높은 가능성을 시사합니다.
- 혼란스러운 기초 매개변수는 발견되지 않았습니다.
CEL-SCI는 FDA와 합의한 212명 환자의 확인 등록 연구를 위해 데이터를 규제 기관에 제출할 준비를 하고 있습니다.
CEL-SCI (NYSE American: CVM) a rapporté des résultats positifs d'une analyse biaisée pour son étude de Phase 3 sur Multikine dans le traitement du cancer de la tête et du cou. L'analyse a montré aucun biais dans l'étude, avec des caractéristiques démographiques et des paramètres de base comparables entre les groupes traités par Multikine et le groupe témoin. Cela soutient la fiabilité des données de l'étude, qui ont démontré l'efficacité de Multikine à prolonger la vie des patients.
Les principaux résultats incluent :
- taux de survie à 5 ans de 73 % chez les patients traités par Multikine contre 45 % dans le groupe témoin pour la population cible
- rapport de risque de 0.35 avec une limite supérieure de 0.66, suggérant une forte probabilité de répéter le bénéfice de survie
- Aucun paramètre de base de confusion détecté
CEL-SCI se prépare à soumettre des données aux régulateurs pour une étude d'enregistrement confirmatoire de 212 patients, convenue avec la FDA.
CEL-SCI (NYSE American: CVM) berichtete über positive Ergebnisse einer Bias-Analyse für seine Phase-3-Studie zu Multikine bei der Behandlung von Kopf- und Halskrebs. Die Analyse zeigte keine Verzerrungen in der Studie, mit vergleichbaren demografischen Daten und Basismerkmalen zwischen den mit Multikine behandelten und den Kontrollgruppen. Dies unterstützt die Zuverlässigkeit der Studiendaten, die die Wirksamkeit von Multikine beim Verlängern des Lebens von Patienten zeigte.
Wichtige Ergebnisse umfassen:
- 5-Jahres-Überlebensrate von 73% bei mit Multikine behandelten Patienten im Vergleich zu 45% in der Kontrollgruppe für die Zielpopulation
- Hazard Ratio von 0.35 mit einer oberen Grenze von 0.66, was auf eine hohe Chance hinweist, den Überlebensvorteil zu wiederholen
- Keine verwirrenden Basisparameter festgestellt
CEL-SCI bereitet sich darauf vor, Daten für eine 212-Patienten-bestätigende Registrierungsstudie einzureichen, die mit der FDA vereinbart wurde.
- Positive bias analysis results support the reliability of Multikine's efficacy data
- 73% 5-year survival rate in Multikine-treated patients vs. 45% in control group for target population
- Hazard ratio of 0.35 with upper limit of 0.66, indicating strong survival benefit
- Agreement with FDA to conduct a 212-patient confirmatory registration study
- None.
Insights
The bias analysis results for CEL-SCI's Phase 3 study of Multikine in head and neck cancer treatment are indeed significant. As a medical research analyst, I find the lack of confounding baseline parameters and the absence of bias particularly noteworthy. This strengthens the credibility of the reported
The hazard ratio of 0.35 with an upper limit of 0.66 is remarkably strong. In layman's terms, this suggests that patients treated with Multikine had about a
However, it's important to note that these results are from a subgroup analysis of 114 patients. While promising, the upcoming 212-patient confirmatory study will be critical in validating these findings. If replicated, it could significantly alter the standard of care for newly diagnosed, resectable, locally advanced primary head and neck cancer patients with no lymph node involvement and low PD-L1 tumor expression.
From a financial perspective, CEL-SCI's announcement carries substantial weight. The positive bias analysis results significantly de-risk the upcoming confirmatory registration study, potentially increasing the likelihood of FDA approval. This could have a profound impact on CEL-SCI's future revenue streams and market valuation.
Investors should note that the head and neck cancer market is projected to reach
However, it's important to temper enthusiasm with caution. While the results are promising, the biotech sector is notoriously volatile. Regulatory hurdles, potential competitors and the need for substantial capital to bring the drug to market are all factors that could impact CEL-SCI's financial outlook. Investors should closely monitor the progress of the confirmatory study and any updates on the company's cash position and burn rate.
As an oncologist, I find the potential of Multikine as a neoadjuvant immunotherapy for head and neck cancer intriguing. The reported
The focus on patients with no lymph node involvement and low PD-L1 expression is particularly interesting. This subgroup has traditionally had options for immunotherapy, as many current treatments target PD-L1 high tumors. Multikine's mechanism of action, which appears to be independent of PD-L1 status, could fill a significant unmet need.
However, it's important to maintain a measured perspective. While the results are promising, they come from a subgroup analysis of a larger trial. The upcoming confirmatory study will be pivotal in validating these findings. Additionally, we'll need to see comprehensive safety data and understand how Multikine integrates with current standard-of-care treatments.
If the confirmatory study replicates these results, Multikine could potentially become a standard part of the treatment regimen for eligible head and neck cancer patients, administered before surgery to prime the immune system and improve long-term outcomes.
- Multikine, a true first-line cancer immunotherapy, cut the 5-year risk of death by half compared to control in its target population
- Bias analysis conducted in preparation for submission of data to regulatory agencies including the FDA for confirmatory registration study
- Detailed data on parameters including patient age, sex, race, tumor locations, and staging demonstrate balance between the treatment and control arms, no bias found, supporting confidence in Multikine’s efficacy results
The above table includes detailed results from the bias analysis involving the 2 groups, treated vs. control (Graphic: Business Wire)
CEL-SCI’s bias analysis concluded that the treatment group demographics and baseline characteristics were comparable for the Multikine treated and control arms of the Phase 3 study. There were no confounding baseline parameters in the Multikine-treated versus control population. No bias was present in the study and none was detected in favor of the investigational product, Multikine. As such, the study data are reliably interpretable, statistically significant and have been shown to support the clinical effect of neoadjuvant (pre-surgery) Multikine immunotherapy in extending the life of these patients in the Phase 3 study.
This is critically important information because CEL-SCI, with the FDA’s agreement, will be conducting a 212-patient confirmatory registration study for Multikine. The target population for the confirmatory study shows a 5-year survival in advanced primary head and neck cancer of
“Multikine’s efficacy results in the target population are truly impressive and the bias analysis is critical to demonstrate a high degree of confidence in the data. A hazard ratio of 0.35 with an upper limit of 0.66 is excellent and suggests a very high chance to repeat the great survival benefit from Multikine. The bias analysis showed that the survival benefit is truly from Multikine as opposed to an imbalance in the patient population,” stated CEL-SCI CEO Geert Kersten. “We are pleased to share the baseline results as we prepare to submit the data to regulators ahead of our upcoming confirmatory registration study.”
The bias analysis was conducted for the entire Phase 3 study population of 923 patients with newly diagnosed resectable, locally advanced primary head and neck cancer, as well as the subgroup of 114 patients who had no lymph node involvement and had low PD-L1 tumor expression (determined via biopsy), the target population for CEL-SCI’s upcoming confirmatory registration study.
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
The Company has operations in
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. Such statements include, but are not limited to, statements about the terms, expected proceeds, use of proceeds and closing of the offering. 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/20240726306579/en/
Gavin de Windt
CEL-SCI Corporation
(703) 506-9460
Source: CEL-SCI Corporation
FAQ
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