FDA’s Oncologic Drugs Advisory Committee Decision on Checkpoint Inhibitors Substantiates Potential of CEL-SCI’s Multikine® to Address Major Treatment Gap for PD-L1 Negative Cancer Patients
CEL-SCI (NYSE American: CVM) announced potential positive implications for its immunotherapy Multikine® following a recent FDA Oncologic Drugs Advisory Committee (ODAC) meeting. The ODAC voted against the risk-benefit profile of PD-L1 inhibitors in various cancers for patients with low PD-L1 expression. This decision highlights a major treatment gap for low and negative PD-L1 cancer patients.
CEL-SCI's Multikine has shown survival benefit and favorable safety profile in a Phase 3 study of treatment-naïve resectable locally advanced head and neck cancer patients with low PD-L1 expression. The company believes Multikine is the only neoadjuvant immunotherapy demonstrating overall survival benefit in this population. CEL-SCI plans to use low PD-L1 expression as a selection criterion in its upcoming FDA confirmatory Registration Study.
CEL-SCI (NYSE American: CVM) ha annunciato potenziali implicazioni positive per la sua immunoterapia Multikine® a seguito di una recente riunione del Comitato Consultivo sui Farmaci Oncologici (ODAC) della FDA. L'ODAC ha votato contro il rapporto rischio-beneficio degli inibitori PD-L1 in vari tumori per pazienti con bassa espressione di PD-L1. Questa decisione evidenzia un importante gap terapeutico per i pazienti oncologici con PD-L1 basso e negativo.
Multikine di CEL-SCI ha dimostrato un beneficio in termini di sopravvivenza e un profilo di sicurezza favorevole in uno studio di Fase 3 su pazienti affetti da cancro testa-collo localmente avanzato, resecabili e naïve al trattamento, con bassa espressione di PD-L1. La società ritiene che Multikine sia l'unica immunoterapia neoadiuvante a dimostrare un beneficio in termini di sopravvivenza globale in questa popolazione. CEL-SCI prevede di utilizzare la bassa espressione di PD-L1 come criterio di selezione nel suo prossimo Studio di Registrazione di conferma FDA.
CEL-SCI (NYSE American: CVM) anunció posibles implicaciones positivas para su inmunoterapia Multikine® tras una reciente reunión del Comité Asesor de Medicamentos Oncológicos (ODAC) de la FDA. El ODAC votó en contra del perfil riesgo-beneficio de los inhibidores de PD-L1 en varios tipos de cáncer para pacientes con baja expresión de PD-L1. Esta decisión destaca una importante brecha en el tratamiento para pacientes con cáncer de PD-L1 bajo y negativo.
El Multikine de CEL-SCI ha mostrado un beneficio en la supervivencia y un perfil de seguridad favorable en un estudio de Fase 3 en pacientes con cáncer de cabeza y cuello localmente avanzado, resecables y naïve al tratamiento, con baja expresión de PD-L1. La empresa cree que Multikine es la única inmunoterapia neoadyuvante que demuestra un beneficio en la supervivencia global en esta población. CEL-SCI planea utilizar la baja expresión de PD-L1 como criterio de selección en su próximo Estudio de Registro de confirmación de la FDA.
CEL-SCI (NYSE American: CVM)는 최근 FDA 종양약물 자문 위원회(ODAC) 회의 이후 면역요법 Multikine®의 잠재적인 긍정적인 함의를 발표했습니다. ODAC는 낮은 PD-L1 발현을 가진 환자에 대해 다양한 암에서 PD-L1 억제제의 위험-이익 프로필에 반대하는 투표를 했습니다. 이 결정은 PD-L1이 낮거나 부정적인 암 환자들에 대한 중요한 치료 격차를 강조하고 있습니다.
CEL-SCI의 Multikine은 낮은 PD-L1 발현을 가진 수술 가능한 국소 진행성 두경부암 환자를 대상으로 한 3상 연구에서 생존 이점과 유리한 안전성 프로필을 보여주었습니다. 회사는 Multikine이 이 인구 집단에서 생존 이점을 입증한 유일한 보조 면역요법이라고 믿고 있습니다. CEL-SCI는 다가오는 FDA 확인 등록 연구에서 낮은 PD-L1 발현을 선정 기준으로 사용할 계획입니다.
CEL-SCI (NYSE American: CVM) a annoncé des implications potentielles positives pour sa thérapie immunitaire Multikine® suite à une récente réunion du Comité Consultatif des Médicaments Oncologiques (ODAC) de la FDA. L'ODAC a voté contre le profil risque-bénéfice des inhibiteurs de PD-L1 dans divers cancers pour les patients ayant une faible expression de PD-L1. Cette décision souligne un important trou de traitement pour les patients atteints de cancer à faible et négatif PD-L1.
Le Multikine de CEL-SCI a montré un bénéfice en termes de survie et un profil de sécurité favorable dans une étude de Phase 3 sur des patients ayant un cancer de la tête et du cou localement avancé, resectables et naïfs de traitement avec une faible expression de PD-L1. L'entreprise estime que Multikine est la seule immunothérapie néoadjuvante à démontrer un bénéfice global en matière de survie dans cette population. CEL-SCI prévoit d'utiliser la faible expression de PD-L1 comme critère de sélection dans son prochaine étude d'enregistrement confirmatoire de la FDA.
CEL-SCI (NYSE American: CVM) hat potenzielle positive Auswirkungen für seine Immuntherapie Multikine® nach einer jüngsten Sitzung des Onkologischen Arzneimittelbeirats (ODAC) der FDA bekannt gegeben. Der ODAC stimmte gegen das Risiko-Nutzen-Profil von PD-L1-Inhibitoren bei verschiedenen Krebsarten für Patienten mit niedriger PD-L1-Expression. Diese Entscheidung hebt eine wesentliche Behandlungslücke für Patienten mit niedrigem und negativem PD-L1 hervor.
Multikine von CEL-SCI zeigte in einer Phase-3-Studie an behandlungsnaiven resektablen, lokal fortgeschrittenen Patienten mit Kopf- und Halskrebs und niedriger PD-L1-Expression einen Überlebensvorteil und ein günstiges Sicherheitsprofil. Das Unternehmen ist der Ansicht, dass Multikine die einzige neoadjuvante Immuntherapie ist, die in dieser Population einen Gesamtüberlebensvorteil zeigt. CEL-SCI plant, die niedrige PD-L1-Expression als Auswahlkriterium in seiner bevorstehenden FDA-Bestätigungsregistrierungsstudie zu verwenden.
- Multikine showed survival benefit in Phase 3 study for low PD-L1 expression head and neck cancer patients
- Potential market opportunity in addressing treatment gap for low and negative PD-L1 cancer patients
- Multikine has potential as a combination drug with current checkpoint inhibitors like Keytruda
- CEL-SCI plans to use low PD-L1 expression as a selection criterion in upcoming FDA confirmatory Registration Study
- None.
Insights
The ODAC's decision highlights a significant gap in treatment options for low PD-L1 expressing cancer patients. This presents a potential opportunity for Multikine, which has shown survival benefits in this underserved population. The 70% of head and neck cancer patients with low PD-L1 expression represent a substantial market.
Multikine's neoadjuvant approach and favorable safety profile could position it well as both a standalone therapy and in combination with existing checkpoint inhibitors. The upcoming FDA confirmatory Registration Study will be important in validating Multikine's efficacy. If successful, it could address a critical unmet need and potentially capture a significant portion of the
While the ODAC decision is promising for CEL-SCI, investors should remain cautious. The company's market cap of
Potential partnership opportunities with major pharma companies marketing checkpoint inhibitors could emerge, as Multikine may complement their existing portfolios. However, CEL-SCI will need substantial funding to complete the confirmatory trial. Investors should monitor the company's cash position and any potential dilutive financing events. The long-term potential is significant if Multikine can capture even a small portion of the multi-billion dollar market, but near-term risks remain high.
- Oncologic Drugs Advisory Committee (ODAC) determines risks outweigh benefits in some cancers for frontline immune checkpoint inhibitors, including blockbuster drugs such as Keytruda and Opdivo, in patients with low PD-L1 expression
- Multikine has shown survival benefit and favorable safety profile in a randomized controlled Phase 3 study of treatment naïve resectable locally advanced head and neck cancer patients with low PD-L1 expression
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Multikine has potential as a combination drug with current checkpoint inhibitors such as Keytruda which is projected to be the top selling drug in the world with
$27 billion - To the Company’s 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
FDA advisory committees provide independent expert advice to the FDA on the safety and effectiveness of new and marketed drugs and help the agency make sound and informed decisions. Advisory committees make non-binding recommendations to the FDA, which generally follows the recommendations but is not legally bound to do so.
The September 27, 2024 ODAC meeting evaluated the use of checkpoint inhibitors on patients with various cancers. PD-L1 is the biomarker most often used for patient selection for checkpoint inhibitors, the most successful class of cancer drugs including Keytruda and Opdivo. The FDA sought the ODAC’s opinion on the following:
- adequacy of PD-L1 expression as a predictive biomarker for patient selection in this patient population
- differing risk-benefit assessments in different subpopulations defined by PD-L1 expression
- adequacy of the cumulative data to restrict the approvals of immune checkpoint inhibitors based on PD-L1 expression
Following a thorough analysis of peer-reviewed published data, the panel of experts on the ODAC voted 10-2 and 11–1 against the risk-benefit profile for PD-L1 inhibitors in various cancers in two separate votes. Most ODAC members expressed concerns about the lack of benefit demonstrated for patients with low PD-L1 expression, while some members pointed to evidence that the use of the immune checkpoint inhibitors may add unnecessary toxicities for patients while also increasing financial burdens on patients.
Checkpoint inhibitors were an estimated
“The FDA advisory committee’s findings and public statement on the risk-benefit of checkpoint inhibitors based on PD-L1 expression is potentially a turning point in cancer treatment, pointing to a major treatment gap in low and negative PD-L1 patients. While the approved blockbuster checkpoint inhibitors, including Keytruda which is expected to be the biggest selling drug in 2024, work well in high PD-L1 expressing patients, to our knowledge, Multikine is the only immunotherapy that is targeted to and has shown survival benefit in the low and negative PD-L1 population. CEL-SCI has already identified in our prior study low PD-L1 expression as a predictive biomarker, representing about
“The FDA’s ODAC decision further supports our belief that Multikine holds strong potential in treating patients across a wider range of solid tumor cancer indications alone and in combination regimens,” Kersten concluded.
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 agreed to 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 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 over 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
What was the outcome of the FDA's Oncologic Drugs Advisory Committee meeting regarding checkpoint inhibitors?
How does the ODAC decision potentially impact CEL-SCI's Multikine (CVM)?
What percentage of head and neck cancer patients have low PD-L1 expression according to CEL-SCI's study?
What is the potential market size for checkpoint inhibitors that Multikine (CVM) could potentially address?
