New Data to be Presented from EFTISARC-NEO Phase II Evaluating Novel Triple Combination including Immutep’s Efti in Soft Tissue Sarcoma
Immutep (ASX: IMM; NASDAQ: IMMP) announced new data from the EFTISARC-NEO Phase II trial will be presented at the Connective Tissue Oncology Society 2024 Annual Meeting. The trial evaluates a novel triple combination of eftilagimod alpha (efti), radiotherapy, and KEYTRUDA® (pembrolizumab) for soft tissue sarcoma (STS) patients. This is the first trial to assess efti in a neoadjuvant setting, providing access to tumor tissue before and after treatment.
Initial efficacy data from May 2024 showed promising results, with most of the first six patients experiencing deep responses rarely seen in STS. STS is an orphan disease with high unmet medical need, affecting ~23,400 cases annually in Europe and an estimated 13,590 new cases in the US in 2024. The open-label study will treat up to 40 patients and is primarily funded by a Polish government grant.
Immutep (ASX: IMM; NASDAQ: IMMP) ha annunciato che nuovi dati dal trial di Fase II EFTISARC-NEO saranno presentati al Congresso Annuale della Connective Tissue Oncology Society 2024. Il trial valuta una novel combinazione tripla di eftilagimod alpha (efti), radioterapia e KEYTRUDA® (pembrolizumab) per i pazienti con sarcoma dei tessuti molli (STS). Questo è il primo trial a valutare efti in un contesto neoadiuvante, fornendo accesso ai tessuti tumorali prima e dopo il trattamento.
I dati iniziali sull’efficacia di maggio 2024 hanno mostrato risultati promettenti, con la maggior parte dei primi sei pazienti che hanno sperimentato risposte profonde rare nel STS. Lo STS è una malattia orfana con un elevato bisogno medico non soddisfatto, che colpisce circa 23.400 casi all'anno in Europa e un stima di 13.590 nuovi casi negli Stati Uniti nel 2024. Lo studio in aperto tratterà fino a 40 pazienti ed è principalmente finanziato da un grant del governo polacco.
Immutep (ASX: IMM; NASDAQ: IMMP) anunció que nuevos datos del ensayo de Fase II EFTISARC-NEO serán presentados en el Congreso Anual de la Connective Tissue Oncology Society 2024. El ensayo evalúa una nueva combinación triple de eftilagimod alpha (efti), radioterapia y KEYTRUDA® (pembrolizumab) para pacientes con sarcoma de tejidos blandos (STS). Este es el primer ensayo en evaluar efti en un contexto neoadyuvante, lo que proporciona acceso al tejido tumoral antes y después del tratamiento.
Los datos iniciales de eficacia de mayo de 2024 mostraron resultados prometedores, con la mayoría de los primeros seis pacientes experimentando respuestas profundas rara vez vistas en el STS. El STS es una enfermedad huérfana con una alta necesidad médica no satisfecha, que afecta aproximadamente a 23.400 casos anuales en Europa y se estima que habrá 13.590 nuevos casos en EE. UU. en 2024. El estudio de etiqueta abierta tratará hasta 40 pacientes y está financiado principalmente por una subvención del gobierno polaco.
Immutep (ASX: IMM; NASDAQ: IMMP)는 EFTISARC-NEO 2상 시험의 새로운 데이터가 2024년 조직 결합 종양학회 연례 회의에서 발표될 것이라고 발표했습니다. 이 시험은 eftilagimod alpha (efti), 방사선 치료 및 KEYTRUDA® (펨브롤리주맙)의 신규 삼중 조합을 연조직 육종 (STS) 환자에 대해 평가합니다. 이 시험은 치료 전후에 종양 조직에 접근할 수 있는 신보조요법 설정에서 efti를 평가하는 첫 번째 시험입니다.
2024년 5월의 초기 효능 데이터는 유망한 결과를 보여주었으며, 첫 6명의 환자 대부분이 STS에서 드물게 나타나는 깊은 반응을 경험했습니다. STS는 연간 약 23,400건의 케이스가 발생하는 유럽에서 높은 의료적 미충족 수요를 가진 고아병입니다. 2024년에는 미국에서 약 13,590건의 새로운 사례가 발생할 것으로 추정됩니다. 공개 라벨 연구는 최대 40명의 환자를 치료하며, 주로 폴란드 정부의 보조금으로 자금을 지원받습니다.
Immutep (ASX: IMM; NASDAQ: IMMP) a annoncé que de nouvelles données de l'
Les données initiales d'efficacité de mai 2024 ont montré des résultats prometteurs, la plupart des six premiers patients ayant connu des réponses profondes rarement observées dans le STS. Le STS est une maladie orpheline avec un fort besoin médical non satisfait, touchant environ 23 400 cas annuels en Europe et estimant 13 590 nouveaux cas aux États-Unis en 2024. L'étude en ouvert traitera jusqu'à 40 patients et est principalement financée par une subvention du gouvernement polonais.
Immutep (ASX: IMM; NASDAQ: IMMP) hat angekündigt, dass neue Daten aus der EFTISARC-NEO Phase-II-Studie auf dem Jahreskongress der Connective Tissue Oncology Society 2024 präsentiert werden. Die Studie bewertet eine neuartige dreifache Kombination aus eftilagimod alpha (efti), Strahlentherapie und KEYTRUDA® (Pembrolizumab) für weichteilsarkom (STS) Patient:innen. Dies ist die erste Studie, die efti in einem neoadjuvanten Setting bewertet und den Zugang zu Tumorgewebe vor und nach der Behandlung ermöglicht.
Die ersten Wirksamkeitsdaten vom Mai 2024 zeigten vielversprechende Ergebnisse, wobei die meisten der ersten sechs Patienten tiefe Reaktionen zeigten, die im STS selten zu beobachten sind. STS ist eine orphan disease mit einem hohen ungedeckten medizinischen Bedarf, der in Europa jährlich etwa 23.400 Fälle betrifft, mit schätzungsweise 13.590 neuen Fällen in den USA im Jahr 2024. Die offene Studie wird bis zu 40 Patienten behandeln und wird hauptsächlich durch einen Fördermittel des polnischen Staates finanziert.
- Novel triple combination therapy showing promising initial results in soft tissue sarcoma
- First trial evaluating efti in a neoadjuvant setting, allowing assessment of tumor microenvironment changes
- Majority of first six patients showed deep responses rarely seen with standard treatments
- Study primarily funded by Polish government grant, reducing company expenses
- Small patient sample size (six patients) for initial efficacy data
- Soft tissue sarcoma is a rare disease with market potential
Insights
The upcoming presentation of data from the EFTISARC-NEO Phase II trial is a significant development for Immutep's eftilagimod alpha (efti). This trial marks the first evaluation of efti in a neoadjuvant setting for soft tissue sarcoma (STS), an orphan disease with poor prognosis and high unmet medical need.
The novel triple combination of efti, radiotherapy and KEYTRUDA® (pembrolizumab) has shown promising initial efficacy in the first six patients, with deep responses rarely observed in STS patients using standard therapies. This could potentially revolutionize the treatment landscape for STS if the full trial results confirm these early findings.
The neoadjuvant approach allows for assessment of efti's impact on the tumor microenvironment, providing valuable insights into its mechanism of action. This data could have far-reaching implications for efti's development in other cancer types and treatment settings.
The EFTISARC-NEO trial's focus on soft tissue sarcoma (STS) is crucial, given the treatment options for this rare and aggressive cancer. With an estimated
The triple combination therapy being tested - efti, radiotherapy and pembrolizumab - is an innovative approach that could potentially enhance the immune response against STS tumors. The neoadjuvant setting is particularly valuable, as it may improve surgical outcomes and provide critical information about treatment efficacy before tumor removal.
If the full trial results corroborate the initial deep responses observed, this could represent a major breakthrough in STS treatment, potentially improving survival rates and quality of life for patients with this challenging disease.
The upcoming presentation at the CTOS 2024 Annual Meeting could be a significant catalyst for Immutep's stock (ASX: IMM; NASDAQ: IMMP). Positive data from the EFTISARC-NEO trial could boost investor confidence in efti's potential across multiple cancer indications.
The focus on an orphan disease like STS is strategically important, as it could lead to expedited regulatory pathways and potential market exclusivity. With an estimated
Investors should note that this trial is primarily funded by a Polish government grant, potentially reducing Immutep's financial burden. However, it's important to await the full data presentation, as early results from a small patient group may not necessarily translate to the entire study population.
- Results from triple combination of efti, radiotherapy and KEYTRUDA® (pembrolizumab) to be presented at the Connective Tissue Oncology Society 2024 Annual Meeting
- EFTISARC-NEO is the first trial to evaluate efti in a neoadjuvant (prior to surgery) setting
- Soft tissue sarcoma is a hard-to-treat orphan disease with poor prognosis & high unmet medical need
SYDNEY, AUSTRALIA, Sept. 18, 2024 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces new data from EFTISARC-NEO, a Phase II investigator-initiated trial of eftilagimod alpha (efti) in combination with radiotherapy plus KEYTRUDA® (pembrolizumab) for patients with soft tissue sarcoma (STS), will be presented at the Connective Tissue Oncology Society (CTOS) 2024 Annual Meeting taking place 13-16 November 2024, in San Diego, California.
| Presentation Details | |
| Title: | Preliminary Results from a Phase 2 EFTISARC-NEO Trial of Neoadjuvant Soluble LAG-3 Protein Eftilagimod Alpha, Pembrolizumab, and Concurrent Radiotherapy in Patients with Resectable Soft Tissue Sarcoma |
| Presenter: | Pawel Sobczuk, M.D., Ph.D., Department of Soft Tissue/Bone Sarcoma and Melanoma, Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland |
| Date: | Thursday, 14 November 2024 |
| Format: | Poster Presentation |
EFTISARC-NEO is the first to evaluate efti in a neoadjuvant setting, which importantly provides access to tumour tissue before and after treatment to assess efti’s impact on the tumour microenvironment. Initial efficacy data from this novel triple combination reported in May 2024 showed very encouraging results in the first six patients with the majority having deep responses rarely seen in STS patients with standard therapeutic approaches.
STS is an orphan disease with high unmet medical need and a poor prognosis for patients. The incidence of STS varies in different regions across Europe, with ~23,400 cases annually according to the RARECARE project. In the United States, the number of new STS cases in 2024 is estimated to be ~13,590 with ~5,200 deaths, according to the American Cancer Society.
The open-label EFTISARC-NEO Phase II study will treat up to 40 patients and is being conducted by the Maria Skłodowska-Curie National Research Institute of Oncology in Warsaw. The trial is primarily funded with an approved grant from the Polish government awarded by the Polish Medical Research Agency program. For more information, visit clinicaltrials.gov (NCT06128863).
Immutep will announce the data to the ASX and make the poster presentation available on the Posters & Publications section of Immutep’s website, after the presentation at CTOS 2024.
About Immutep
Immutep is a clinical-stage biotechnology company developing novel LAG-3 immunotherapy for cancer and autoimmune disease. We are pioneers in the understanding and advancement of therapeutics related to Lymphocyte Activation Gene-3 (LAG-3), and our diversified product portfolio harnesses its unique ability to stimulate or suppress the immune response. Immutep is dedicated to leveraging its expertise to bring innovative treatment options to patients in need and to maximise value for shareholders. For more information, please visit www.immutep.com.
Australian Investors/Media:
Catherine Strong, Sodali & Co.
+61 (0)406 759 268; catherine.strong@sodali.com
U.S. Media:
Chris Basta, VP, Investor Relations and Corporate Communications
+1 (631) 318 4000; chris.basta@immutep.com
FAQ
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