Immutep Reports Promising New Data in Head and Neck Cancer at ESMO Immuno-Oncology 2024
Immutep (NASDAQ: IMMP) has announced promising clinical results from Cohort B of the TACTI-003 Phase IIb trial, evaluating eftilagimod alpha (efti) combined with KEYTRUDA® in head and neck cancer patients. The study shows significant improvements in patients with PD-L1 CPS <1 expression, including:
- Median overall survival (OS) not yet reached with 67% 12-month OS rate
- Progression-free survival of 5.8 months
- 35.5% objective response rate
- Complete response rate of 12.9% (RECIST 1.1) and 16.1% (iRECIST)
- Median duration of response of 9.3 months
These results significantly outperform historical controls of anti-PD-1 therapy alone, which showed 7.9-month median OS and 39% 12-month OS rate. The treatment continues to be well-tolerated with no new safety signals.
Immutep (NASDAQ: IMMP) ha annunciato risultati clinici promettenti dal Cohorte B dello studio TACTI-003 di fase IIb, che valuta l'eftilagimod alfa (efti) combinato con KEYTRUDA® in pazienti con tumori della testa e del collo. Lo studio mostra miglioramenti significativi nei pazienti con espressione di PD-L1 CPS <1, tra cui:
- Sopravvivenza overall mediana (OS) non ancora raggiunta con un tasso di OS a 12 mesi del 67%
- Sopravvivenza libera da progressione di 5,8 mesi
- Tasso di risposta obiettiva del 35,5%
- Tasso di risposta completa del 12,9% (RECIST 1.1) e 16,1% (iRECIST)
- Durata mediana della risposta di 9,3 mesi
Questi risultati superano significativamente i controlli storici della sola terapia anti-PD-1, che mostravano una sopravvivenza mediana di 7,9 mesi e un tasso di OS a 12 mesi del 39%. Il trattamento continua a essere ben tollerato senza nuovi segnali di sicurezza.
Immutep (NASDAQ: IMMP) ha anunciado resultados clínicos prometedores del Cohorte B del ensayo TACTI-003 de fase IIb, que evalúa el eftilagimod alfa (efti) combinado con KEYTRUDA® en pacientes con cáncer de cabeza y cuello. El estudio muestra mejoras significativas en pacientes con expresión de PD-L1 CPS <1, incluyendo:
- Supervivencia general mediana (OS) aún no alcanzada con una tasa de OS a 12 meses del 67%
- Supervivencia libre de progresión de 5,8 meses
- Tasa de respuesta objetiva del 35,5%
- Tasa de respuesta completa del 12,9% (RECIST 1.1) y 16,1% (iRECIST)
- Duración mediana de respuesta de 9,3 meses
Estos resultados superan significativamente los controles históricos de la terapia anti-PD-1 sola, que mostraban una supervivencia mediana de 7,9 meses y una tasa de OS a 12 meses del 39%. El tratamiento sigue siendo bien tolerado sin nuevos señales de seguridad.
Immutep (NASDAQ: IMMP)는 TACTI-003 2상 B군 임상시험에서 KEYTRUDA®와 결합된 eftilagimod alpha(efte)에 대한 유망한 결과를 발표했습니다. 이 연구는 PD-L1 CPS <1 발현을 가진 환자에서 중요한 개선 사항을 보여주고 있으며, 포함된 내용은:
- 12개월 OS 비율이 67%인 중위 전체 생존(OS) 도달되지 않음
- 무진행 생존 기간 5.8개월
- 객관적 반응율 35.5%
- 완전 반응율 12.9% (RECIST 1.1) 및 16.1% (iRECIST)
- 반응의 중위 지속 기간 9.3개월
이 결과는 단독으로 항-PD-1 치료의 역사적 대조군보다 크게 개선된 것으로, 7.9개월의 중위 OS와 39%의 12개월 OS 비율을 보여주었습니다. 이 치료는 새로운 안전성 신호 없이 잘 견디고 있습니다.
Immutep (NASDAQ: IMMP) a annoncé des résultats cliniques prometteurs de la Cohorte B de l'essai TACTI-003 de phase IIb, évaluant l'eftilagimod alpha (efti) en combinaison avec KEYTRUDA® chez des patients atteints de cancer de la tête et du cou. L'étude montre des améliorations significatives chez les patients avec une expression de PD-L1 CPS <1, y compris :
- Survie globale médiane (OS) non atteinte avec un taux de 12 mois de survie globale de 67%
- Survie sans progression de 5,8 mois
- Taux de réponse objective de 35,5%
- Taux de réponse complète de 12,9% (RECIST 1.1) et 16,1% (iRECIST)
- Durée médiane de réponse de 9,3 mois
Ces résultats surpassent significativement les contrôles historiques de la thérapie anti-PD-1 seule, qui montraient une survie médiane de 7,9 mois et un taux de survie de 12 mois de 39%. Le traitement continue d'être bien toléré, sans nouveaux signaux de sécurité.
Immutep (NASDAQ: IMMP) hat vielversprechende klinische Ergebnisse aus der Kohorte B der TACTI-003 Phase IIb Studie bekannt gegeben, die eftilagimod alpha (efti) in Kombination mit KEYTRUDA® bei Patienten mit Kopf- und Halskrebs bewertet. Die Studie zeigt signifikante Verbesserungen bei Patienten mit PD-L1 CPS <1 Expression, einschließlich:
- Medianes Gesamtüberleben (OS) noch nicht erreicht mit einer 12-Monats-OS-Rate von 67%
- Progressionsfreies Überleben von 5,8 Monaten
- Objektive Ansprechrate von 35,5%
- Vollständige Ansprechrate von 12,9% (RECIST 1.1) und 16,1% (iRECIST)
- Median der Ansprechdauer von 9,3 Monaten
Diese Ergebnisse übertreffen signifikant historische Kontrollen der alleinigen anti-PD-1-Therapie, die ein medianes OS von 7,9 Monaten und eine 12-Monats-OS-Rate von 39% zeigten. Die Behandlung wird weiterhin gut vertragen, ohne neue Sicherheitszeichen.
- Median overall survival (OS) not yet reached with 67% 12-month OS rate, significantly higher than historical 39%
- Strong progression-free survival of 5.8 months vs historical 2.1 months
- High objective response rate of 35.5% compared to historical 5.4%
- Increased complete response rate to 12.9-16.1% vs no complete responses historically
- Favorable safety profile with no new safety signals
- None.
Insights
The clinical data from TACTI-003 Phase IIb trial demonstrates remarkable efficacy in a historically difficult-to-treat patient population. The combination of efti with pembrolizumab shows significant improvements across key metrics compared to historical controls:
The durability metrics are equally impressive, with median OS not yet reached and a median duration of response of 9.3 months. This represents a substantial advancement for HNSCC patients with PD-L1 CPS <1, who typically have poor outcomes with current standard treatments. The potential to avoid chemotherapy in this population could be paradigm-shifting.
This data release significantly strengthens Immutep's market position in the competitive immuno-oncology space. The impressive efficacy in PD-L1 low expressors addresses an unmet medical need in approximately
The robust survival data and increased complete response rates could accelerate regulatory discussions and potentially lead to a faster path to market. For investors, this positive data reduces clinical risk and enhances the probability of successful commercialization. The company's market cap of
- Data shows strong overall survival, progression-free survival, and durability from novel combination of efti in combination with pembrolizumab in difficult-to-treat head and neck cancer patients with PD-L1 CPS <1
- Positively, median overall survival (OS) has not yet been reached and the 12-month OS rate is
67% , both well above historical controls - Complete response rate increases to
12.9% and16.1% , according to RECIST 1.1 and iRECIST, respectively - Treatment continues to be well tolerated
SYDNEY, AUSTRALIA, Dec. 12, 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 positive clinical results from Cohort B of the TACTI-003 (KEYNOTE-C34) Phase IIb trial. This study evaluates eftilagimod alpha (efti) in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in first line recurrent/metastatic head and neck squamous cell carcinoma (1L HNSCC) patients with negative PD-L1 expression.
The new promising data presented by Martin Forster, M.D., Ph.D., at the ESMO Immuno-Oncology (IO) Annual Congress 2024 includes strong overall survival, progression-free survival, and durability. This adds to the high response rates and favourable safety data previously reported on 12 July 2024.
Prof. Martin Forster of the UCL Cancer Institute and University College London Hospital NHS Foundation Trust, London, UK, and TACTI-003 Investigator, stated, “The new survival and durability data, coupled with increasing complete responses, build on the strong response rates already established with this novel IO combination in head and neck squamous cell cancers with PD-L1 CPS <1. This difficult-to-treat disease places a high burden on patients who unfortunately have very limited treatment options that all include chemotherapy. Collectively, these impressive results build on the potential promise of efti to improve patient outcomes and expand populations that respond to anti-PD-1.”
Results
Data as of the 31 October 2024 cut-off date in evaluable 1L HNSCC patients (N=31) whose tumours express PD-L1 below 1 (Combined Positive Score [CPS] <1) and who typically do not respond well to anti-PD-1 therapy alone shows:
- Positively, median overall survival (OS) has not yet been reached and the 12-month OS rate is
67% - Promising progression-free survival (PFS) of 5.8 months
- Strong durability with interim median duration of response (DOR) of 9.3 months
- High
35.5% objective response rate (ORR) and58.1% disease control rate (DCR), as reported on 12 July - Complete response rate increases to
12.9% and16.1% , according to RECIST 1.1 and iRECIST, respectively1 - Efti in combination with pembrolizumab continues to be well-tolerated with no new safety signals
This data compares favourably to historical results from anti-PD-1 therapy alone in 1L HNSCC patients with PD-L1 CPS <1 including a 7.9-month median OS, 12-month OS rate of
Marc Voigt, CEO of Immutep, noted, “Despite the significant progress of cancer immunotherapy over the past decade and the positive change in the therapeutic landscape it has brought to bear, head and neck cancer patients with PD-L1 expression of less than one continue to have limited treatment options that all include chemotherapy. We believe this data is an encouraging step in the right direction towards potentially bringing a new approach to this underserved population, representing up to
Next Steps
Patients with PD-L1 CPS <1 is an underserved patient population with limited treatment options. Immutep will continue to follow the maturing data from TACTI-003 and engage with regulatory authorities regarding potential paths forward.
The ESMO IO poster is available on the Posters & Publications section of Immutep’s website.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
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.
- Complete response rate was
9.6% , according to RECIST 1.1 and iRECIST, respectively, at earlier cut-off date as previously reported on 12 July 2024 - 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. Note, the
5.4% ORR and32.4% DCR are calculated from the 37 evaluable patients with CPS <1. - 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
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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