U.S. FDA and CEL-SCI Agree on Use of PD-L1 Biomarker to Select Head and Neck Cancer Patients for Marketing Registration Study to Commence Q1 2025
CEL-SCI (NYSE: CVM) announced FDA agreement on using PD-L1 biomarker for patient selection in its upcoming Multikine Registration Study for head and neck cancer, starting Q1 2025. The study will focus on patients with low PD-L1 tumor expression, following promising results from a previous Phase 3 study where patients showed 73% vs. 45% five-year survival rate compared to control group. The new study will enroll approximately 212 patients with newly diagnosed locally advanced primary head and neck cancer without lymph node involvement. Multikine shows better effectiveness in patients with low PD-L1 expression, which represents about 70% of head and neck cancer cases.
CEL-SCI (NYSE: CVM) ha annunciato l'accordo della FDA per l'uso del biomarker PD-L1 nella selezione dei pazienti per il suo prossimo studio di registrazione Multikine per il cancro testa-collo, che avrà inizio nel primo trimestre del 2025. Lo studio si concentrerà su pazienti con bassa espressione tumorale di PD-L1, dopo i risultati promettenti di un precedente studio di fase 3 in cui i pazienti hanno mostrato un tasso di sopravvivenza a cinque anni del 73% contro il 45% rispetto al gruppo di controllo. Il nuovo studio recluterà circa 212 pazienti con cancro testa-collo primario localmente avanzato di recente diagnosi, senza coinvolgimento dei linfonodi. Multikine mostra una maggiore efficacia nei pazienti con bassa espressione di PD-L1, che rappresentano circa il 70% dei casi di cancro testa-collo.
CEL-SCI (NYSE: CVM) anunció el acuerdo de la FDA para usar el biomarcador PD-L1 en la selección de pacientes para su próximo estudio de registro de Multikine para el cáncer de cabeza y cuello, que comenzará en el primer trimestre de 2025. El estudio se centrará en pacientes con baja expresión tumoral de PD-L1, tras los resultados prometedores de un estudio de fase 3 anterior donde los pacientes mostraron un tasa de sobrevivencia del 73% frente al 45% en comparación con el grupo de control. El nuevo estudio inscribirá aproximadamente a 212 pacientes con cáncer de cabeza y cuello primario localmente avanzado recién diagnosticado, sin involucramiento de ganglios linfáticos. Multikine muestra una mejor eficacia en pacientes con baja expresión de PD-L1, que representan aproximadamente el 70% de los casos de cáncer de cabeza y cuello.
CEL-SCI (NYSE: CVM)는 다가오는 두경부 암에 대한 Multikine 등록 연구에서 환자 선정을 위해 PD-L1 바이오마커를 사용할 수 있다는 FDA의 합의를 발표했습니다. 연구는 2025년 1분기부터 시작됩니다. 이전 3상 연구의 유망한 결과에 따라 PD-L1 종양 발현이 낮은 환자에 초점을 맞출 것입니다. 그 연구에서 환자들은 대조군과 비교하여 5년 생존율이 73%대 45%를 나타냈습니다. 새로운 연구는 림프절 침범 없이 새롭게 진단된 국소 진행성 두경부 암 환자 약 212명을 등록할 예정입니다. Multikine은 PD-L1 발현이 낮은 환자에서 더 나은 효과를 보이며, 이는 두경부 암 사례의 약 70%를 차지합니다.
CEL-SCI (NYSE: CVM) a annoncé un accord avec la FDA pour utiliser le biomarqueur PD-L1 dans la sélection des patients lors de son prochain étude d'enregistrement Multikine pour le cancer de la tête et du cou, qui débutera au premier trimestre 2025. L'étude se concentrera sur des patients avec une faible expression tumorale de PD-L1, suite à des résultats prometteurs d'une étude de phase 3 précédente où les patients ont montré un taux de survie à cinq ans de 73 % contre 45 % par rapport au groupe témoin. La nouvelle étude inscrira environ 212 patients nouvellement diagnostiqués avec un cancer primitif avancé de la tête et du cou sans atteinte des ganglions lymphatiques. Multikine montre une meilleure efficacité chez les patients avec une faible expression de PD-L1, représentant environ 70 % des cas de cancer de la tête et du cou.
CEL-SCI (NYSE: CVM) gab bekannt, dass die FDA dem Einsatz des PD-L1 Biomarkers zur Patienten Auswahl in ihrer bevorstehenden Multikine Registrierungsstudie für Kopf- und Halskrebs zugestimmt hat, die im ersten Quartal 2025 beginnen wird. Die Studie wird sich auf Patienten mit geringer PD-L1 Tumorexpression konzentrieren, nach vielversprechenden Ergebnissen aus einer früheren Phase-3-Studie, in der Patienten eine 5-Jahres-Überlebensrate von 73% gegenüber 45% im Vergleich zur Kontrollgruppe zeigten. Die neue Studie wird voraussichtlich rund 212 Patienten mit neu diagnostiziertem lokal fortgeschrittenem primärem Kopf- und Halskrebs ohne Lymphknoteneinbeziehung rekrutieren. Multikine zeigt eine bessere Wirksamkeit bei Patienten mit niedriger PD-L1-Expression, die etwa 70% der Fälle von Kopf- und Halskrebs darstellen.
- Previous Phase 3 study showed significant survival improvement (73% vs 45%) in target population
- FDA agreement on patient selection method strengthens study design
- Large potential market as 70% of head and neck cancer patients have low PD-L1 expression
- Unique positioning in $48 billion global checkpoint inhibitor market
- New Registration Study won't start until Q1 2025
- patient enrollment of 212 participants in upcoming study
Insights
The FDA's agreement on using PD-L1 as a biomarker for patient selection represents a significant milestone for CEL-SCI's Multikine development. The data showing
The inverse relationship between PD-L1 levels and Multikine efficacy provides a clear differentiation from existing checkpoint inhibitors like Keytruda and Opdivo. This positions Multikine uniquely in the
This development strengthens CEL-SCI's market positioning in the head and neck cancer space. With Keytruda projected at
The FDA's agreement on the biomarker strategy adds regulatory clarity and reduces development risk. For a company with a
- Biomarker used to select patients who are more likely have favorable outcomes, supporting a successful confirmatory Registration Study
-
Patients with low PD-L1 expression treated with Multikine in the target population had a 5-year survival of
73% vs.45% in the control group in the prior randomized controlled Phase 3 study
PD-L1 is a widely used biomarker for cancer patient selection for checkpoint inhibitors, a class of cancer drugs representing a
“To our knowledge, Multikine is the only neoadjuvant immunotherapy that has shown overall survival benefit in the low and negative PD-L1 head and neck cancer population. This underscores the critical importance of having reached an agreement with the FDA on the method for identifying and selecting patients with low PD-L1 tumor expression for our upcoming confirmatory Registration study,” stated CEL-SCI CEO Geert Kersten.
“Patient selection based on low PD-L1 as a biomarker can boost the success of our upcoming confirmatory trial, further enhancing our confidence based on the retrospective data from our Phase 3 study. We appreciate the ongoing dialog, exchange of ideas and information with the FDA in support of CEL-SCI’s groundbreaking work as we aim to treat an unmet need in cancer patients with low PD-L1 expression.”
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 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 very strong 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 small, focused, confirmatory Registration Study which will enroll 212 patients. CEL-SCI will enroll 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 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.
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Gavin de Windt
CEL-SCI Corporation
(703) 506-9460
Source: CEL-SCI Corporation
FAQ
When will CEL-SCI (CVM) start its new Multikine Registration Study?
What was the survival rate difference in CVM's Phase 3 Multikine study?
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What percentage of head and neck cancer patients have low PD-L1 expression suitable for CVM's Multikine?
