Immutep Receives Positive Feedback from FDA on Late-Stage Clinical Development of Eftilagimod Alfa in Head and Neck Cancer with CPS <1
Immutep (NASDAQ: IMMP) has received positive FDA feedback regarding the clinical development of eftilagimod alfa (efti) for first-line treatment of head and neck cancer patients with PD-L1 expression below 1 (CPS <1). The feedback follows encouraging data from the TACTI-003 Phase IIb trial evaluating efti in combination with KEYTRUDA®.
The FDA has outlined two potential development paths: a randomized registrational trial against standard-of-care therapy or a smaller single-arm study (70-90 patients) followed by a confirmatory randomized study. This development aligns with FDA's Project FrontRunner initiative, targeting earlier clinical settings in cancer treatment.
The company notes that up to 20% of first-line HNSCC patients have CPS <1, representing a significant unmet medical need, as current treatment options for these patients all include chemotherapy.
Immutep (NASDAQ: IMMP) ha ricevuto un riscontro positivo dalla FDA riguardo allo sviluppo clinico di eftilagimod alfa (efti) per il trattamento di prima linea dei pazienti con tumore della testa e del collo con espressione di PD-L1 inferiore a 1 (CPS <1). Il feedback segue dati incoraggianti dal trial di fase IIb TACTI-003 che valuta efti in combinazione con KEYTRUDA®.
La FDA ha indicato due possibili percorsi di sviluppo: uno studio registrativo randomizzato contro la terapia standard o uno studio a braccio singolo più piccolo (70-90 pazienti) seguito da uno studio randomizzato di conferma. Questo sviluppo è in linea con l'iniziativa Project FrontRunner della FDA, che mira a trattamenti oncologici in fasi cliniche più precoci.
L'azienda sottolinea che fino al 20% dei pazienti con HNSCC di prima linea presenta CPS <1, rappresentando un bisogno medico significativo, poiché le opzioni terapeutiche attuali per questi pazienti includono tutte la chemioterapia.
Immutep (NASDAQ: IMMP) ha recibido comentarios positivos de la FDA sobre el desarrollo clínico de eftilagimod alfa (efti) para el tratamiento de primera línea en pacientes con cáncer de cabeza y cuello con expresión de PD-L1 inferior a 1 (CPS <1). Los comentarios siguen a datos alentadores del ensayo de fase IIb TACTI-003 que evalúa efti en combinación con KEYTRUDA®.
La FDA ha señalado dos posibles vías de desarrollo: un ensayo registracional aleatorizado contra la terapia estándar o un estudio de un solo brazo más pequeño (70-90 pacientes) seguido de un estudio aleatorizado confirmatorio. Este desarrollo está alineado con la iniciativa Project FrontRunner de la FDA, que apunta a entornos clínicos más tempranos en el tratamiento del cáncer.
La compañía destaca que hasta un 20% de los pacientes con HNSCC de primera línea tienen CPS <1, representando una necesidad médica significativa, ya que las opciones de tratamiento actuales para estos pacientes incluyen siempre quimioterapia.
Immutep (NASDAQ: IMMP)는 PD-L1 발현이 1 미만(CPS <1)인 두경부암 1차 치료 환자들을 위한 eftilagimod alfa(efti)의 임상 개발에 대해 FDA로부터 긍정적인 피드백을 받았습니다. 이 피드백은 KEYTRUDA®와 병용한 TACTI-003 2상 임상시험의 고무적인 데이터에 따른 것입니다.
FDA는 두 가지 가능한 개발 경로를 제시했습니다: 표준 치료와 비교하는 무작위 등록 임상시험 또는 소규모 단일군 연구(70-90명) 후 확인 무작위 연구 진행. 이 개발은 암 치료의 초기 임상 환경을 목표로 하는 FDA의 Project FrontRunner 이니셔티브와 일치합니다.
회사는 1차 HNSCC 환자의 최대 20%가 CPS <1에 해당하며, 이 환자군은 모두 화학요법을 포함하는 현재 치료 옵션으로 인해 중요한 미충족 의료 수요가 있다고 언급했습니다.
Immutep (NASDAQ : IMMP) a reçu un retour positif de la FDA concernant le développement clinique de eftilagimod alfa (efti) pour le traitement de première ligne des patients atteints de cancer de la tête et du cou avec une expression de PD-L1 inférieure à 1 (CPS <1). Ce retour fait suite à des données encourageantes issues de l'essai de phase IIb TACTI-003 évaluant efti en combinaison avec KEYTRUDA®.
La FDA a proposé deux voies potentielles de développement : un essai d’enregistrement randomisé contre la thérapie standard ou une étude monocentrique plus petite (70-90 patients) suivie d’une étude randomisée confirmatoire. Ce développement s’inscrit dans l’initiative Project FrontRunner de la FDA, visant des contextes cliniques plus précoces dans le traitement du cancer.
La société souligne que jusqu’à 20 % des patients atteints de HNSCC en première ligne ont un CPS <1, représentant un besoin médical important, car les options de traitement actuelles pour ces patients incluent toutes une chimiothérapie.
Immutep (NASDAQ: IMMP) hat positives Feedback von der FDA zum klinischen Entwicklungsprogramm von eftilagimod alfa (efti) für die Erstlinienbehandlung von Kopf-Hals-Krebs-Patienten mit PD-L1-Expression unter 1 (CPS <1) erhalten. Das Feedback folgt auf ermutigende Daten aus der TACTI-003 Phase IIb-Studie, die efti in Kombination mit KEYTRUDA® bewertet.
Die FDA hat zwei mögliche Entwicklungswege skizziert: eine randomisierte Zulassungsstudie gegen die Standardtherapie oder eine kleinere Einarmstudie (70-90 Patienten), gefolgt von einer bestätigenden randomisierten Studie. Diese Entwicklung entspricht der Project FrontRunner-Initiative der FDA, die frühere klinische Settings in der Krebstherapie anvisiert.
Das Unternehmen weist darauf hin, dass bis zu 20 % der Erstlinien-HNSCC-Patienten einen CPS <1 aufweisen, was einen erheblichen ungedeckten medizinischen Bedarf darstellt, da die aktuellen Behandlungsoptionen für diese Patienten alle Chemotherapie einschließen.
- None.
- Company's primary focus remains on TACTI-004 Phase III for lung cancer, potentially delaying HNSCC development
- Additional strategic partners may be needed for head and neck cancer development path
Insights
FDA provides positive feedback on Immutep's efti for head & neck cancer patients with low PD-L1 expression, offering potential new treatment pathway.
The FDA's positive feedback to Immutep regarding eftilagimod alfa (efti) represents a significant development for head and neck squamous cell carcinoma (HNSCC) patients with PD-L1 expression below 1 (CPS <1). This underserved population, comprising up to 20% of first-line HNSCC patients, currently has limited treatment options, all requiring chemotherapy.
The TACTI-003 Phase IIb trial results appear compelling enough that the FDA has outlined two potential development paths: either a randomized registrational trial against standard-of-care or a smaller single-arm study (70-90 patients) focusing on safety, response rate, and duration of response, followed by a confirmatory randomized study.
What makes this particularly noteworthy is the FDA's inclusion of this development under Project FrontRunner, an initiative specifically designed to advance promising therapies to earlier treatment settings rather than waiting until patients have exhausted other options. This signals the agency recognizes both the unmet need and efti's potential to address it.
Mechanistically, efti is a first-in-class MHC Class II agonist that appears to complement pembrolizumab's PD-1 inhibition. This combination could potentially offer these low PD-L1 expressing patients an immunotherapy option without chemotherapy - something currently unavailable to them. While the company's primary focus remains on their Phase III lung cancer trial (TACTI-004), this FDA feedback creates valuable optionality for Immutep's clinical development strategy and potential partnerships.
SYDNEY, AUSTRALIA, Aug. 05, 2025 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a late-stage immunotherapy company targeting cancer and autoimmune diseases, today announces it has received positive and constructive feedback from the US Food and Drug Administration (FDA), regarding future clinical development of its first-in-class MHC Class II agonist, eftilagimod alfa (“efti”), for first line treatment of recurrent/metastatic head and neck squamous cell carcinoma (1L HNSCC) patients who have PD-L1 expression below 1 (Combined Positive Score [CPS] <1).
Based on its review of the encouraging data in 1L HNSCC with CPS <1 from the TACTI-003 (KEYNOTE-C34) Phase IIb trial evaluating efti in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 KEYTRUDA® (pembrolizumab), the FDA agreed on the potential of efti in combination with KEYTRUDA to address the high unmet need in this CPS <1 patient segment and is supportive of the combination’s further development.
Paths for future clinical development and potential accelerated approval in light of the FDA’s Project FrontRunner include a randomised registrational trial evaluating efti in combination with KEYTRUDA against standard-of-care therapy or alternatively a smaller single-arm study (e.g. 70 - 90 patients) with safety, response rate, and duration of response as key endpoints, followed by a confirmatory randomised study that builds on the existing data.
“We are pleased with the FDA’s feedback and guidance that underscores the high unmet need of head and neck cancer patients whose PD-L1 expression level is below one. The FDA feedback positions Immutep to evaluate options for future collaborative clinical development paths to bring a new, effective and safe treatment option to this underserved patient population,” said Marc Voigt, CEO of Immutep.
“Our primary focus clearly remains the pivotal TACTI-004 Phase III evaluating efti as first line therapy for non-small cell lung cancer and we are excited with its progress to date and the consistent, encouraging feedback we hear from physicians. This focus and additional considerations will be reviewed internally and discussed with stakeholders and potential strategic partners in regards to forward paths in head and neck cancer,” added Mr Voigt.
Project FrontRunner is an FDA Oncology Center of Excellence (OCE) initiative to encourage drug sponsors to consider when it may be appropriate to develop and seek approval of cancer drugs for advanced/metastatic disease, in an earlier clinical setting rather than the usual approach to develop and seek approval of a drug for treatment of patients who have received numerous prior lines of therapies or have exhausted available treatment options. In this setting, advancing new effective therapies has the greatest potential to significantly improve quantity and quality of patients’ lives.
Patients with CPS <1 in 1L HNSCC represent a treatment population with high unmet medical need. Up to
About Immutep
Immutep is a late-stage biotechnology company developing novel immunotherapies for cancer and autoimmune disease. The Company is a pioneer in the understanding and advancement of therapeutics related to Lymphocyte Activation Gene-3 (LAG-3), and its diversified product portfolio harnesses LAG-3’s 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.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
Australian Investors/Media:
Eleanor Pearson, Sodali & Co.
+61 2 9066 4071; eleanor.pearson@sodali.com
U.S. Investors/Media:
Chris Basta, VP, Investor Relations and Corporate Communications
+1 (631) 318 4000; chris.basta@immutep.com
FAQ
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