Immutep’s Efti in Combination with KEYTRUDA® (pembrolizumab) Drives Strong Overall Survival in Head and Neck Cancer with CPS <1
Immutep (NASDAQ: IMMP) has announced exceptional results from its TACTI-003 Phase IIb trial, showing a median Overall Survival (OS) of 17.6 months for head and neck cancer patients with PD-L1 CPS <1. The trial evaluated eftilagimod alfa (efti) combined with KEYTRUDA® in first-line therapy for recurrent/metastatic head and neck squamous cell carcinoma.
The results significantly outperform current standard-of-care treatments, which show OS of 10.7 months for cetuximab + chemotherapy and 11.3 months for anti-PD-1 therapy + chemotherapy. The combination therapy was well-tolerated with no new safety concerns. Notably, this represents a potential breakthrough for the 20% of patients with CPS <1, who currently have no chemotherapy-free treatment options.
The company has requested an FDA meeting to discuss potential paths to approval, leveraging its Fast Track designation in 1L HNSCC.
Immutep (NASDAQ: IMMP) ha annunciato risultati eccezionali dal suo studio di Fase IIb TACTI-003, mostrando una sopravvivenza mediana globale (OS) di 17,6 mesi per pazienti con tumore della testa e del collo con PD-L1 CPS <1. Lo studio ha valutato eftilagimod alfa (efti) in combinazione con KEYTRUDA® come terapia di prima linea per carcinoma squamoso ricorrente/metastatico della testa e del collo.
I risultati superano significativamente i trattamenti standard attuali, che mostrano una OS di 10,7 mesi per cetuximab + chemioterapia e 11,3 mesi per terapia anti-PD-1 + chemioterapia. La terapia combinata è stata ben tollerata senza nuove preoccupazioni di sicurezza. In particolare, rappresenta una possibile svolta per il 20% dei pazienti con CPS <1, che attualmente non hanno opzioni di trattamento senza chemioterapia.
L'azienda ha richiesto un incontro con la FDA per discutere potenziali vie di approvazione, sfruttando la designazione Fast Track per HNSCC di prima linea.
Immutep (NASDAQ: IMMP) ha anunciado resultados excepcionales de su ensayo de Fase IIb TACTI-003, mostrando una supervivencia global mediana (OS) de 17,6 meses para pacientes con cáncer de cabeza y cuello con PD-L1 CPS <1. El ensayo evaluó eftilagimod alfa (efti) combinado con KEYTRUDA® en terapia de primera línea para carcinoma escamoso recurrente/metastásico de cabeza y cuello.
Los resultados superan significativamente los tratamientos estándar actuales, que muestran una OS de 10,7 meses para cetuximab + quimioterapia y 11,3 meses para terapia anti-PD-1 + quimioterapia. La terapia combinada fue bien tolerada sin nuevas preocupaciones de seguridad. Notablemente, esto representa un posible avance para el 20% de pacientes con CPS <1, que actualmente no tienen opciones de tratamiento sin quimioterapia.
La compañía ha solicitado una reunión con la FDA para discutir posibles vías de aprobación, aprovechando su designación Fast Track en HNSCC de primera línea.
Immutep (NASDAQ: IMMP)는 TACTI-003 2상 임상시험에서 뛰어난 결과를 발표했습니다. PD-L1 CPS <1인 두경부암 환자에서 중앙 전체 생존 기간(OS)이 17.6개월로 나타났습니다. 이 임상시험은 재발/전이성 두경부 편평세포암 1차 치료제로서 eftilagimod alfa (efti)와 KEYTRUDA®의 병용요법을 평가했습니다.
이 결과는 기존 표준 치료법인 세툭시맙 + 화학요법(10.7개월) 및 항-PD-1 치료 + 화학요법(11.3개월)보다 현저히 우수합니다. 병용요법은 새로운 안전성 문제 없이 잘 견뎌졌습니다. 특히, CPS <1인 환자 20%에게 현재 화학요법 없는 치료 옵션이 없는 상황에서 획기적인 진전이 될 수 있습니다.
회사는 1차 HNSCC에서 Fast Track 지정 혜택을 활용하여 승인 경로 논의를 위해 FDA와의 미팅을 요청했습니다.
Immutep (NASDAQ : IMMP) a annoncé des résultats exceptionnels issus de son essai de phase IIb TACTI-003, montrant une survie globale médiane (OS) de 17,6 mois chez des patients atteints de cancer de la tête et du cou avec un PD-L1 CPS <1. L'essai a évalué l'eftilagimod alfa (efti) en combinaison avec KEYTRUDA® en traitement de première ligne pour le carcinome épidermoïde récidivant/métastatique de la tête et du cou.
Les résultats surpassent significativement les traitements standards actuels, qui affichent une OS de 10,7 mois pour le cetuximab + chimiothérapie et 11,3 mois pour la thérapie anti-PD-1 + chimiothérapie. La thérapie combinée a été bien tolérée sans nouvelles préoccupations de sécurité. Notamment, cela représente une avancée potentielle pour les 20 % de patients avec CPS <1, qui n'ont actuellement pas d'options de traitement sans chimiothérapie.
L'entreprise a demandé une réunion avec la FDA pour discuter des voies potentielles d'approbation, tirant parti de sa désignation Fast Track en HNSCC de première ligne.
Immutep (NASDAQ: IMMP) hat herausragende Ergebnisse aus seiner Phase-IIb-Studie TACTI-003 bekannt gegeben, die eine medianes Gesamtüberleben (OS) von 17,6 Monaten bei Patienten mit Kopf-Hals-Krebs und PD-L1 CPS <1 zeigen. Die Studie bewertete eftilagimod alfa (efti) in Kombination mit KEYTRUDA® als Erstlinientherapie für rezidivierenden/metastasierten Plattenepithelkarzinom des Kopfes und Halses.
Die Ergebnisse übertreffen die aktuellen Standardbehandlungen deutlich, die ein OS von 10,7 Monaten für Cetuximab + Chemotherapie und 11,3 Monate für Anti-PD-1-Therapie + Chemotherapie zeigen. Die Kombinationstherapie wurde gut vertragen, ohne neue Sicherheitsbedenken. Bemerkenswert ist, dass dies einen potenziellen Durchbruch für die 20 % der Patienten mit CPS <1 darstellt, die derzeit keine chemotherapiefreien Behandlungsoptionen haben.
Das Unternehmen hat ein Treffen mit der FDA beantragt, um mögliche Zulassungswege zu besprechen und nutzt dabei die Fast-Track-Zulassung für die Erstlinienbehandlung von HNSCC.
- Achieved exceptional 17.6-month median Overall Survival, significantly higher than current treatment options
- Treatment shows 7-fold increase in response rates compared to anti-PD-1 monotherapy
- Well-tolerated safety profile with no new safety signals
- Addresses high unmet medical need for 20% of 1L HNSCC patients
- Fast Track designation from FDA already secured
- Still requires FDA approval for commercialization
- Limited patient sample size (N=31) in the trial
Insights
Efti + Keytruda shows impressive 17.6-month survival in PD-L1 negative head and neck cancer, potentially offering chemotherapy-free option for undertreated patients.
The clinical results for eftilagimod alfa (efti) combined with pembrolizumab in head and neck cancer patients with PD-L1 CPS <1 are remarkably strong. The 17.6-month median overall survival significantly outperforms current standards: cetuximab+chemotherapy (10.7 months), anti-PD-1+chemotherapy (11.3 months), and anti-PD-1 monotherapy (7.9 months).
This represents a potential paradigm shift for these patients with "cold tumors" (low PD-L1 expression). Currently, these patients—representing up to 20% of first-line HNSCC cases—lack approved immunotherapy-only options, with all available treatments requiring chemotherapy.
The complementary mechanism of action explains these results. Efti activates antigen-presenting cells through LAG-3, essentially "warming up" cold tumors to make them responsive to pembrolizumab's PD-1 blockade. This immunotherapy-only approach has driven a 7-fold increase in response rates compared to historical anti-PD-1 monotherapy data, including multiple complete responses.
Most significantly, this represents a potential chemotherapy-free treatment pathway for patients currently required to undergo chemotherapy's toxicities and side effects. The combination maintains a favorable safety profile with no new safety signals reported.
With the FDA Fast Track designation and upcoming regulatory discussions, this could address a critical unmet need in head and neck cancer treatment.
Immutep's strong survival data provides potential regulatory pathway for efti+pembrolizumab in underserved head/neck cancer subpopulation with few treatment options.
Immutep's Phase IIb TACTI-003 results significantly strengthen the company's clinical and regulatory position. The 17.6-month median overall survival in CPS <1 head and neck cancer patients represents a substantial improvement over current standards and addresses a specific high-need patient population with limited treatment options.
The strategic focus on PD-L1 negative (CPS <1) patients is particularly astute from a development perspective. This subpopulation—comprising approximately 20% of first-line HNSCC cases—faces a substantial unmet need as they lack approved non-chemotherapy options. Current competitors have largely overlooked this specific segment, creating an opportunity for differentiation.
The regulatory pathway appears increasingly defined. With Fast Track designation already secured and an FDA meeting requested, Immutep may have potential accelerated approval opportunities if regulators find the magnitude of benefit compelling enough. The company indicates they'll discuss "potential paths to approval" with the FDA.
The chemotherapy-free approach represents a key commercial differentiator. All currently approved treatments for CPS <1 patients require chemotherapy, making this potentially the first immunotherapy-only option for this population.
While additional data updates are expected later this year as patient follow-up continues, these results provide strong momentum for Immutep's lead program in a well-defined market segment with clear unmet medical needs and limited competition.
- Complementary nature of these two immunotherapies leads to excellent 17.6-month median Overall Survival in head and neck cancer patients with PD-L1 CPS <1
- Mature overall survival data builds on encouraging high response rates with multiple complete responses
- Patients with CPS <1 represent a high unmet medical need and have no available treatment options without chemotherapy
- Meeting with FDA has now been requested to discuss next steps including potential paths to approval
SYDNEY, AUSTRALIA, May 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 an excellent median Overall Survival (OS) of 17.6 months has been achieved in Cohort B of the TACTI-003 (KEYNOTE-C34) Phase IIb trial. This part of the Phase II study evaluates eftilagimod alfa (efti) in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) as first line therapy in recurrent/metastatic head and neck squamous cell carcinoma (1L HNSCC) patients with PD-L1 expression below 1 (Combined Positive Score [CPS] <1).
The mature 17.6-months median OS in evaluable patients (N=31) with a data cut-off of 31 March 2025 compares favourably to historical results from the two current standard-of-care approaches for 1L HNSCC patients with CPS <1 including 10.7-months from cetuximab + chemotherapy and 11.3-months from anti-PD-1 therapy + chemotherapy, as well as 7.9-months from anti-PD-1 monotherapy.1,2
Patients with CPS <1 in 1L HNSCC represent a treatment population with high unmet medical need. Up to
Importantly, efti in combination with pembrolizumab continues to be well-tolerated with no new safety signals. This safety and mature OS data build on the encouraging high overall response rate with multiple complete responses achieved through combining these powerful immunotherapies in 1L HNSCC patients with CPS <1.3
“We are excited to see this strong survival benefit for head and neck cancer patients with such cold tumors. Combining these two complementary immunotherapies has led to a 7-fold increase in response rates and a more than doubling of median overall survival as compared to historical results from anti-PD-1 monotherapy. Driving durable responses that translate into clinically meaningful survival holds tremendous promise for these patients in need of more tolerable and efficacious therapies,” said Marc Voigt, CEO of Immutep.
“There is a high unmet need in 1L HNSCC patients with cold tumors and PD-L1 CPS <1, due to the lack of an approved immunotherapy-only treatment regimen and a lack of competitor trials with chemotherapy-free approaches targeting this patient population. Given the strength of the efficacy and safety results generated to date with efti in combination with pembrolizumab, we will meet with regulators to discuss next steps and potential paths to approval,” added Mr. Voigt.
Next Steps
Efti has Fast Track designation in 1L HNSCC and Immutep has requested a meeting with the U.S. Food and Drug Administration (FDA) to discuss next steps including potential paths to approval for 1L HNSCC with PD-L1 CPS <1. Patient follow up, data collection, cleaning and analysis continue for TACTI-003, and the Company plans to provide a further update later this year.
About Eftilagimod Alfa (efti)
Efti is Immutep’s proprietary soluble LAG-3 protein and MHC Class II agonist that stimulates both innate and adaptive immunity for the treatment of cancer. As a first-in-class antigen presenting cell (APC) activator, efti binds to MHC (major histocompatibility complex) Class II molecules on APC leading to activation and proliferation of CD8+ cytotoxic T cells, CD4+ helper T cells, dendritic cells, NK cells, and monocytes. It also upregulates the expression of key biological molecules like IFN-ƴ and CXCL10 that further boost the immune system’s ability to fight cancer.
Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and metastatic breast cancer. Its favourable safety profile enables various combinations, including with anti-PD-[L]1 immunotherapy and/or chemotherapy. Efti has received Fast Track designation in first line HNSCC and in first line NSCLC from the United States Food and Drug Administration (FDA).
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.
- Burtness, B. et al. Pembrolizumab Alone or With Chemotherapy for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma in KEYNOTE-048: Subgroup Analysis by Programmed Death Ligand-1 Combined Positive Score. Journal of Clinical Oncology 2022 40:21, 2321-2332.
- Burtness B. et al. Abstract LB-258: Efficacy of first-line (1L) pembrolizumab by PD-L1 combined positive score <1, 1-19, and ≥20 in recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC): KEYNOTE-048 subgroup analysis. Cancer Res 15 August 2020; 80 (16_Supplement): LB–258. https://doi.org/10.1158/1538-7445.AM2020-LB-258
- Forster M. et al., ESMO Immuno-Oncology 2024 - December 2024, TACTI-003 Cohort B: Eftilagimod Alpha (Soluble LAG-3) and Pembrolizumab in First-Line Recurrent or Metastatic Head & Neck Squamous Cell Carcinoma with CPS <1
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
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