CEL-SCI’s Multikine® Increased 5-Year Survival Rate to 82.6% in Locally Advanced Resectable Head & Neck Cancer Patients Who Were Deemed to be in the Treatment Group for Surgery and Radiation
CEL-SCI (NYSE American: CVM) reported new data from its Phase 3 study of Multikine® at the ESMO 2024 Congress. The data shows that Multikine increased the 5-year survival rate to 82.6% in locally advanced resectable head and neck cancer patients deemed low risk for recurrence, compared to 47.3% with standard care alone. The treatment also demonstrated a 73% reduction in overall risk of death (hazard ratio of 0.27).
These results are highly relevant to CEL-SCI's upcoming 212-patient confirmatory Registration Study, which has received FDA approval. The study will focus on patients with newly diagnosed locally advanced primary head and neck cancer with no lymph node involvement and low PD-L1 tumor expression. The data suggests that better diagnostic technology, such as PET scans, could further optimize patient selection and improve Multikine's efficacy.
CEL-SCI (NYSE American: CVM) ha riportato nuovi dati dal suo studio di Fase 3 su Multikine® al Congresso ESMO 2024. I dati mostrano che Multikine ha aumentato il tasso di sopravvivenza a 5 anni all'82,6% nei pazienti con tumori testa-collo avanzati e resecabili, ritenuti a basso rischio di recidiva, rispetto al 47,3% con la sola cura standard. Il trattamento ha anche dimostrato una riduzione del 73% del rischio complessivo di morte (rapporto di rischio di 0,27).
Questi risultati sono particolarmente rilevanti per il prossimo studio di registrazione confermativo su 212 pazienti di CEL-SCI, che ha ricevuto l'approvazione della FDA. Lo studio si concentrerà su pazienti con tumori primari testa-collo localmente avanzati, recentemente diagnosticati, senza coinvolgimento dei linfonodi e con bassa espressione del tumore PD-L1. I dati suggeriscono che tecnologie diagnostiche migliori, come le scansioni PET, potrebbero ulteriormente ottimizzare la selezione dei pazienti e migliorare l'efficacia di Multikine.
CEL-SCI (NYSE American: CVM) informó nuevos datos de su estudio de Fase 3 sobre Multikine® en el Congreso ESMO 2024. Los datos muestran que Multikine aumentó la tasa de supervivencia a 5 años al 82,6% en pacientes con cáncer de cabeza y cuello localmente avanzado, resecables y considerados de bajo riesgo de recurrencia, en comparación con el 47,3% con el tratamiento estándar solo. El tratamiento también demostró una reducción del 73% en el riesgo general de muerte (ratio de hazard de 0,27).
Estos resultados son muy relevantes para el próximo estudio de registro confirmatorio de CEL-SCI, que incluye a 212 pacientes y que ha recibido la aprobación de la FDA. El estudio se centrará en pacientes con cáncer de cabeza y cuello primario localmente avanzado recién diagnosticado, sin afectación de ganglios linfáticos y con baja expresión del tumor PD-L1. Los datos sugieren que mejores tecnologías de diagnóstico, como las exploraciones PET, podrían optimizar aún más la selección de pacientes y mejorar la eficacia de Multikine.
CEL-SCI (NYSE American: CVM)는 ESMO 2024 Congress에서 Multikine®에 대한 3상 연구의 새로운 데이터를 보고했습니다. 데이터에 따르면 Multikine은 국소적으로 진행된 절제 가능한 두경부암 환자에서 5년 생존율을 82.6%로 증가시켰습니다, 재발 위험이 낮은 환자와 비교할 때 표준 치료만 사용할 경우 47.3%였습니다. 이 치료는 또한 전체 사망 위험을 73% 감소 시켰습니다 (위험 비율 0.27).
이 결과는 FDA 승인을 받은 CEL-SCI의 향후 212명 환자를 대상으로 한 확인 등록 연구와 매우 관련이 있습니다. 이 연구는 림프절 침범이 없고 낮은 PD-L1 종양 발현을 가진 새로 진단된 국소적으로 진행된 두경부암 환자에 초점을 맞출 것입니다. 데이터는 PET 스캔과 같은 더 나은 진단 기술이 환자 선택을 더욱 최적화하고 Multikine의 효능을 향상시킬 수 있음을 시사합니다.
CEL-SCI (NYSE American: CVM) a rapporté de nouvelles données de son étude de Phase 3 sur Multikine® lors du Congrès ESMO 2024. Les données montrent que Multikine a augmenté le taux de survie à 5 ans à 82,6% chez les patients atteints de cancer de la tête et du cou localement avancé et résécable, jugés à faible risque de récidive, par rapport à 47,3% avec le traitement standard seul. Le traitement a également montré une réduction de 73% du risque global de décès (ratio de risque de 0,27).
Ces résultats sont d'une grande pertinence pour l'étude d'enregistrement confirmatoire de CEL-SCI sur 212 patients, qui a reçu l'approbation de la FDA. L'étude se concentrera sur des patients récemment diagnostiqués avec un cancer primitif de la tête et du cou localement avancé sans atteinte des ganglions lymphatiques et avec une faible expression du PD-L1. Les données suggèrent que de meilleures technologies de diagnostic, comme les scannings PET, pourraient encore optimiser la sélection des patients et améliorer l'efficacité de Multikine.
CEL-SCI (NYSE American: CVM) berichtete über neue Daten aus seiner Phase-3-Studie zu Multikine® auf dem ESMO 2024 Kongress. Die Daten zeigen, dass Multikine die 5-Jahres-Überlebensrate auf 82,6% bei lokal fortgeschrittenen resektablen Kopf-Hals-Krebspatienten erhöht hat, die als niedriges Rückfallrisiko eingeschätzt wurden, im Vergleich zu 47,3% mit Standardbehandlung allein. Die Behandlung zeigte auch eine 73%ige Verringerung des Gesamtrisikos des Todes (Hazard Ratio von 0,27).
Diese Ergebnisse sind äußerst relevant für die bevorstehende Bestätigungsregistrierungsstudie von CEL-SCI, die 212 Patienten umfasst und die FDA-Zulassung erhalten hat. Die Studie wird sich auf Patienten mit neu diagnostiziertem lokal fortgeschrittenem primärem Kopf-Hals-Krebs ohne Lymphknotenbeteiligung und niedriger PD-L1-Tumorexpression konzentrieren. Die Daten deuten darauf hin, dass bessere Diagnose-Technologien wie PET-Scans die Patientenauswahl weiter optimieren und die Wirksamkeit von Multikine verbessern könnten.
- Multikine increased 5-year survival rate to 82.6% in low-risk patients vs 47.3% with standard care
- 73% reduction in overall risk of death (hazard ratio of 0.27) for low-risk patients
- FDA approved 212-patient confirmatory Registration Study
- Potential for further optimization of patient selection using PET scans
- Multikine showed no survival benefit for high-risk patients requiring chemotherapy
Insights
The new data from CEL-SCI's Phase 3 study of Multikine® in head and neck cancer patients is highly promising. The 82.6% 5-year survival rate for low-risk patients treated with Multikine, compared to 47.3% for standard care, is a significant improvement. The 73% reduction in overall risk of death (hazard ratio 0.27) is particularly impressive.
These results suggest Multikine could be a game-changer for certain head and neck cancer patients. The study's focus on patients with no lymph node involvement and low PD-L1 expression appears to be a key factor in identifying those who benefit most. The potential to improve outcomes further with advanced diagnostic tools like PET scans is intriguing.
However, it's important to note that these results are from a subset analysis of the original study. While promising, they need confirmation in the upcoming 212-patient Registration Study. If replicated, Multikine could significantly improve the standard of care for a specific subset of head and neck cancer patients.
The results for Multikine in locally advanced resectable head and neck cancer are remarkably positive. The 82.6% 5-year survival rate in low-risk patients is exceptional, considering the typical survival rates for this disease are below 50%. The hazard ratio of 0.27 indicates a substantial reduction in mortality risk.
What's particularly interesting is the enhanced efficacy in patients not receiving chemotherapy post-surgery. This aligns with our understanding of immunotherapy's mechanisms, which can be hindered by chemotherapy's immunosuppressive effects. The potential to use PET scans for better patient selection could further optimize these outcomes.
However, we must be cautious. These results come from a subset analysis, which can sometimes overestimate treatment effects. The upcoming Registration Study will be important in validating these findings. If confirmed, Multikine could represent a significant advance in neoadjuvant immunotherapy for head and neck cancer, potentially changing treatment paradigms for selected patients.
CEL-SCI's latest data on Multikine® presents a potentially significant market opportunity. The 82.6% 5-year survival rate in selected patients is a substantial improvement over current standards, which could drive strong demand if approved. The 73% reduction in overall risk of death is a compelling statistic that could influence treatment decisions and payer policies.
The company's focus on a specific patient subset (no lymph node involvement, low PD-L1 expression) could lead to a targeted market strategy. This approach might result in faster adoption and potentially higher pricing power. The planned 212-patient Registration Study is a critical next step. Positive results could significantly boost CEL-SCI's market position and valuation.
However, investors should note that the path to market still involves regulatory hurdles. The company's financial position and ability to fund the upcoming study and potential commercialization will be important factors to monitor. While the data is promising, the stock remains a speculative investment until Multikine achieves regulatory approval.
-
5-year survival rate of
82.6% and73% reduction in overall risk of death (hazard ratio of 0.27) are the strongest Multikine efficacy results reported to date, reflecting results in patients who met the CEL-SCI confirmatory Registration Study target population criteria and were deemed at low risk for recurrence, therefore not recommended per NCCN guidelines to receive chemotherapy post-surgery - Data provide further evidence that the selection criteria for CEL-SCI’s upcoming confirmatory Registration Study may yield improved clinical outcomes
-
Future advances in diagnostic technologies that improve patient selection, such as PET scans (which will be used in the confirmatory study), may further optimize patient selection and Multikine’s already strong efficacy results from the current 5-year Overall Survival at
73% up into the82% range -
Clear unmet need: the 5-year survival rate remains below
50% in locally advanced resectable head and neck cancer patients who receive standard of care only
CEL-SCI’s Multikine® Increases Head and Neck Cancer 5-Year Survival Rate to
Summary of Phase 3 Study: Multikine-treated patients who were recommended treatment of surgery and radiotherapy had a nearly 4-year survival benefit over control group
As previously reported, CEL-SCI’s completed Phase 3 study of 923 patients showed that newly diagnosed head and neck cancer patients who were deemed at low risk for recurrence after surgery (and therefore recommended to receive only radiotherapy after surgery) had a median overall survival (OS) benefit of 46.5-months, almost 4-years, over control patients. However, patients who were deemed to be high risk for recurrence after surgery (and therefore recommended to have chemotherapy added to the radiotherapy after surgery) showed no survival benefit.
Upcoming FDA Confirmatory Registration Study
Since the completed Phase 3 study showed clear survival benefit for some, but not all of the patients, the FDA requested that CEL-SCI conduct a confirmatory Registration Study focusing on the patients who showed the best survival benefit. Based on the data, CEL-SCI determined this target population to be patients with newly diagnosed locally advanced primary head and neck cancer with no lymph node involvement and with low PD-L1 tumor expression. Applying these selection criteria to the completed Phase 3 study of 923 patients resulted in the target population (n=114) having a
Summary of New Data Presented at ESMO
The new data presented at ESMO includes a further analysis of the 114 patients in the completed Phase 3 study who met these target population selection criteria and form the basis for the confirmatory study. Specifically, the new analysis focused on those patients who were deemed low risk for recurrence (recommended to be given only radiotherapy – but no chemotherapy, per National Comprehensive Cancer Network “NCCN” guidelines) following surgery (n=79) as opposed to the selected patients who were deemed high risk for recurrence and who were recommended to have chemotherapy added to their treatment following surgery per the same guidelines (n=35).
While the overall survival benefit was clear and statistically significant (log rank p=0.0015) for the entire target population (n=114), the 79 patients who were recommended to receive only radiotherapy benefited to an even greater degree from pre-surgery treatment with Multikine than the group of 114 as a whole. This target low risk population (n=38) had a 5-year overall survival of
Management Commentary
“The additional data presented this weekend at ESMO 2024 provides further evidence that we have identified the target population that has the greatest survival benefit from Multikine, and that our study criteria can select for these patients upon diagnosis, before surgery,” stated CEL-SCI CEO Geert Kersten. “It makes sense that Multikine, an immunotherapy, provides even greater benefit to patients who are not scheduled to receive chemotherapy following surgery, given the known detriments of chemotherapy on the immune system. Seeing more clearly than ever that patients who were not recommended chemotherapy benefited the most begs the question: What if, through better diagnostic technology such as the PET scan, which we will be using in the confirmatory study, resulting in better patient selection, we could treat only those patients who are supposed to be treated with radiotherapy alone, and not chemotherapy? The data presented at ESMO is clear. This would lead to even better 5-year survival,
CEL-SCI’s CSO Eyal Talor, Ph.D. commented, “The criteria we developed for selecting these locally advanced head and neck cancer patients clearly showed that when patients were treated with Multikine before surgery, they demonstrated an overall survival advantage over control irrespective of whether these patients were characterized as being at low- or high-risk for recurrence following surgery. With this new analysis we also saw that patients selected by these criteria who are deemed low risk for recurrence post-surgery have a further improved survival outcome with a hazard ratio of 0.27, which even is better than the already exceptional hazard ratio of 0.34 seen for the overall selected population.”
The data were presented at ESMO 2024 by the study’s co-author József Tímár MD, PhD, DSc, Professor Department of Pathology, Forensic and Insurance Medicine at Semmelweis University in
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240916023296/en/
Gavin de Windt
CEL-SCI Corporation
(703) 506-9460
Source: CEL-SCI Corporation
FAQ
What is the 5-year survival rate for Multikine-treated low-risk head and neck cancer patients?
What is the reduction in overall risk of death for Multikine-treated patients in the CVM study?
Has the FDA approved CEL-SCI's (CVM) confirmatory Registration Study for Multikine?
What patient group showed the best results with Multikine in CEL-SCI's (CVM) Phase 3 study?
