New Study in the Scientific Journal “Cancer Cell” Supports CEL-SCI’s Strategy to Seek Early Approval for Multikine in Head and Neck Cancer Based on Pre-Surgical Tumor Responses
CEL-SCI (NYSE American: CVM) has received support for its strategy to seek early approval for Multikine in head and neck cancer treatment. A new study in Cancer Cell validates that pre-surgical tumor responses lead to improved survival outcomes.
Key findings from CEL-SCI's Phase 3 trial showed that patients treated with Multikine before surgery achieved a 73% five-year survival rate compared to 45% in the control group. The study demonstrated 45 objective early responders, including 5 complete pathological responders, with a significant 306% overall survival prolongation. Responders showed a notably lower death rate of 22.2% versus 54.1% for non-responders.
The company has received FDA approval for a 212-patient Confirmatory Registration Study to verify these results. Multikine is administered as a neoadjuvant therapy immediately after diagnosis and before surgery.
CEL-SCI (NYSE American: CVM) ha ricevuto supporto per la sua strategia di ottenere un'approvazione anticipata per Multikine nel trattamento del cancro testa-collo. Un nuovo studio pubblicato su Cancer Cell convalida che le risposte tumorali pre-chirurgiche portano a migliori risultati di sopravvivenza.
I risultati chiave del trial di Fase 3 di CEL-SCI hanno mostrato che i pazienti trattati con Multikine prima dell'intervento chirurgico hanno raggiunto un 73% di tasso di sopravvivenza a cinque anni rispetto al 45% del gruppo di controllo. Lo studio ha dimostrato 45 rispondenti obiettivi precoci, inclusi 5 rispondenti patologici completi, con un significativo 306% di prolungamento della sopravvivenza globale. I rispondenti hanno mostrato un tasso di mortalità notevolmente più basso del 22,2% rispetto al 54,1% per i non rispondenti.
L'azienda ha ricevuto l'approvazione della FDA per uno studio di Registrazione Confermativa su 212 pazienti per verificare questi risultati. Multikine viene somministrato come terapia neoadiuvante immediatamente dopo la diagnosi e prima dell'intervento chirurgico.
CEL-SCI (NYSE American: CVM) ha recibido apoyo para su estrategia de buscar una aprobación temprana para Multikine en el tratamiento del cáncer de cabeza y cuello. Un nuevo estudio en Cancer Cell valida que las respuestas tumorales prequirúrgicas conducen a mejores resultados de supervivencia.
Los hallazgos clave del ensayo de Fase 3 de CEL-SCI mostraron que los pacientes tratados con Multikine antes de la cirugía lograron una tasa de supervivencia del 73% a cinco años en comparación con el 45% en el grupo de control. El estudio demostró 45 respondedores objetivos tempranos, incluidos 5 respondedores patológicos completos, con un prolongamiento de la supervivencia global del 306% significativo. Los respondedores mostraron una tasa de mortalidad notablemente más baja del 22,2% frente al 54,1% de los no respondedores.
La compañía ha recibido la aprobación de la FDA para un Estudio de Registro Confirmatorio de 212 pacientes para verificar estos resultados. Multikine se administra como terapia neoadyuvante inmediatamente después del diagnóstico y antes de la cirugía.
CEL-SCI (NYSE American: CVM)는 두경부 암 치료를 위한 Multikine의 조기 승인을 추구하는 전략에 대한 지원을 받았습니다. Cancer Cell에 발표된 새로운 연구는 수술 전 종양 반응이 생존 결과를 개선한다는 것을 확인합니다.
CEL-SCI의 3상 시험에서 주요 결과는 수술 전에 Multikine으로 치료받은 환자들이 대조군의 45%에 비해 73%의 5년 생존율을 달성했다는 것입니다. 이 연구는 45명의 객관적인 조기 반응자를 포함하여 5명의 완전 병리학적 반응자를 보여주었으며, 306%의 전반적인 생존 기간 연장을 나타냈습니다. 반응자들은 비반응자에 비해 22.2%의 현저히 낮은 사망률을 보였습니다(비반응자는 54.1%).
회사는 이러한 결과를 검증하기 위해 212명의 환자를 대상으로 하는 FDA의 확인 등록 연구 승인을 받았습니다. Multikine은 진단 직후 수술 전에 보조 요법으로 투여됩니다.
CEL-SCI (NYSE American: CVM) a reçu un soutien pour sa stratégie visant à obtenir une approbation précoce pour Multikine dans le traitement du cancer de la tête et du cou. Une nouvelle étude dans Cancer Cell valide que les réponses tumorales préchirurgicales conduisent à de meilleurs résultats de survie.
Les résultats clés de l'essai de Phase 3 de CEL-SCI ont montré que les patients traités avec Multikine avant la chirurgie ont atteint un taux de survie à cinq ans de 73% contre 45% dans le groupe témoin. L'étude a démontré 45 répondants objectifs précoces, dont 5 répondants pathologiques complets, avec un prolongement de la survie globale de 306% significatif. Les répondants ont montré un taux de mortalité remarquablement plus bas de 22,2% contre 54,1% pour les non-répondants.
L'entreprise a reçu l'approbation de la FDA pour une étude d'enregistrement confirmatoire de 212 patients afin de vérifier ces résultats. Multikine est administré comme une thérapie néoadjuvante immédiatement après le diagnostic et avant la chirurgie.
CEL-SCI (NYSE American: CVM) hat Unterstützung für seine Strategie erhalten, eine frühzeitige Genehmigung für Multikine zur Behandlung von Kopf- und Halskrebs zu suchen. Eine neue Studie in Cancer Cell bestätigt, dass präoperative Tumorreaktionen zu verbesserten Überlebensraten führen.
Die wichtigsten Ergebnisse der Phase-3-Studie von CEL-SCI zeigten, dass Patienten, die vor der Operation mit Multikine behandelt wurden, eine 73%ige Fünf-Jahres-Überlebensrate im Vergleich zu 45% in der Kontrollgruppe erreichten. Die Studie wies 45 objektive frühe Ansprecher aus, darunter 5 vollständige pathologische Ansprecher, mit einer signifikanten 306%igen Verlängerung der Gesamtüberlebenszeit. Die Ansprecher wiesen eine bemerkenswert niedrigere Sterberate von 22,2% im Vergleich zu 54,1% bei den Nicht-Ansprechern auf.
Das Unternehmen hat die Genehmigung der FDA für eine Bestätigungsregistrierungsstudie mit 212 Patienten erhalten, um diese Ergebnisse zu überprüfen. Multikine wird als neoadjuvante Therapie unmittelbar nach der Diagnose und vor der Operation verabreicht.
- 73% five-year survival rate in treated patients vs 45% in control group
- 306% overall survival prolongation in responders
- Significantly lower death rate in responders (22.2%) vs non-responders (54.1%)
- 45 objective early responders, including 5 complete tumor disappearances
- FDA approval received for Confirmatory Registration Study
- Additional confirmatory study required before potential approval
- Results to pre-surgical (neoadjuvant) treatment window
Insights
This third-party validation in Cancer Cell provides significant credibility to CEL-SCI's clinical approach for Multikine. The correlation between pre-surgical tumor response and improved survival outcomes in head and neck cancer patients represents a crucial scientific finding that aligns perfectly with CEL-SCI's development strategy.
The Phase 3 results are particularly noteworthy: patients receiving Multikine before surgery showed a
The FDA's agreement to proceed with a 212-patient Confirmatory Registration Study indicates regulatory recognition of this approach. The
This announcement reveals a strategic regulatory approach that could accelerate Multikine's path to market. CEL-SCI is pursuing an efficient approval strategy by leveraging early tumor response as a surrogate endpoint—a pathway that has successfully secured accelerated approvals for numerous oncology drugs.
The independent validation from the Cancer Cell study provides critical external support for their regulatory argument. With both their own Phase 3 data and now third-party evidence indicating pre-surgical tumor responses correlate with survival in head and neck cancer, CEL-SCI has strengthened their case for an accelerated approval pathway.
The FDA's clearance of their 212-patient Confirmatory Registration Study design suggests regulatory receptiveness to this approach. While full approval would typically require overall survival data, the surrogate endpoint strategy could potentially trim years off the development timeline. The specific survival improvements (
Head and neck cancer patients treated with Multikine who had complete or partial tumor responses before surgery had improvements in overall survival, suggesting pre-surgical tumor response is a strong indicator of efficacy and leads to improved overall survival
A third-party head and neck cancer study published in “Cancer Cell” confirms the observation that pre-surgical tumor responses in head and neck cancer leads to improved survival
The concept that tumor responses predict survival has been acknowledged for many cancer types and has led to accelerated approval of many cancer drugs. The study in Cancer Cell, which had 41 evaluable patients, gives further support that this is also true in the neoadjuvant pre-surgical immunotherapy treatment of head and neck cancer.
“The data from both our completed Multikine neoadjuvant Phase 3 study and the study published in Cancer Cell show that newly diagnosed locally advanced head and neck cancer patients who were treated with immune therapies before surgery and had tumor responses, were also likely to have better overall survival. This is quite logical—when a person’s tumor shrinks in response to immunotherapy treatment before the tumor is removed by surgery—their survival outcome is expected to be better,” stated CEL-SCI CEO Geert Kersten. “We believe that the recent greater availability of peer-reviewed published data specific to neoadjuvant therapy and early tumor response in head and neck cancer supports our development and regulatory efforts.”
CEL-SCI’s 212-patient Confirmatory Registration Study, which has received the FDA’s go-ahead, is designed to verify the statistically significant efficacy and safety results from the Company’s previously completed Phase 3 randomized controlled Multikine trial.
During the Multikine Phase 3 clinical trial, the 5-year survival rate of the target patient population for the confirmatory study increased to
As a neoadjuvant therapy, Multikine is given to patients right after diagnosis, prior to surgery. In the Phase 3 study, pre-surgery objective early tumor response to treatment with Multikine was confirmed by pathology at surgery. There were 45 objective early responders, of which 5 were complete pathological responders, whose tumors completely disappeared in the Multikine treated group, within the 3-weeks of Multikine treatment. There were zero responders reported in the control group pre-surgery. Pre-surgical responders exhibited a
About CEL-SCI Corporation
CEL-SCI has been a pioneer in advocating the use of neoadjuvant cancer immunotherapy. We believe that the greatest benefit for patients can only be achieved if you boost a patient’s immune system before surgery, radiotherapy and chemotherapy have damaged it. 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), given right after diagnosis and before surgery, has been dosed in over 740 patients and received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck. Based on the data from the completed randomized controlled Phase 3 study, the FDA concurred with CEL-SCI’s target patient selection criteria and gave the go-ahead to conduct a confirmatory Registration Study. The study will enroll 212 newly diagnosed locally advanced primary treatment naïve resectable head and neck cancer patients with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy), representing about 100,000 patients annually.
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. 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, inability to finalize a partnering agreement 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, 2024. 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.
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Gavin de Windt
CEL-SCI Corporation
(703) 506-9460
Source: CEL-SCI Corporation
FAQ
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