Drugs / Eftilagimod Alfa
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials · 1 met primary | ||||||
| Phase 2 | NCT07102940 | Sep 2026 → Aug 2028 expected | Her2-receptor negative breast cancer | George Washington University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06128863 | Jul 2023 → Apr 2025 overdue | soft tissue sarcoma | Maria Sklodowska-Curie National Research Institute of Oncology | Active not recruiting | Met primary |
| Phase 31 trial | ||||||
| Phase 3 | NCT06726265 | Mar 2025 → Jun 2027 expected | non-small cell lung carcinoma | Immutep S.A.S. | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 15
| Date | Issuer | Release |
|---|---|---|
| 2026-07-13 | Immutep S.A.S. | Results Immutep Provides Clinical Update in 1st line NSCLC: Positive Mature Overall Survival Data from INSIGHT-003 and Update from TACTI-004 immutep.com ↗
With a minimum of 30 months of follow-up, median Overall Survival (mOS) was 30.9 months in the overall population regardless of PD-L1 expression (N=51), with the same mOS observed in patients with TPS <50% (N=47) and 37.8 months in TPS>=50% (N=4). |
| 2026-05-28 | Immutep S.A.S. | Results Systemic immune activation with eftilagimod alfa associated with statistically significant increased overall survival in late-stage cancer patients immutep.com ↗
A clinically meaningful and significant median overall survival (OS) improvement (median +7.7 months; p=0.0017 1 ) was seen in ALC responders compared to ALC non-responders in the efti + SOC group (figure on the left). |
| 2026-04-22 | Immutep S.A.S. | Results Immutep Announces Abstract Accepted for Presentation at the American Society of Clinical Oncology (ASCO) 2026 Annual Meeting immutep.com ↗
The poster will present cumulative clinical and translational data demonstrating that eftilagimod alfa (efti), an antigen-presenting cell (APC) activator targeting MHC Class II, induces rapid and sustained lymphocyte activation. |
| 2026-04-15 | Immutep S.A.S. | Regulatory Immutep Receives FDA Orphan Drug Designation for Eftilagimod Alfa in Soft Tissue Sarcoma immutep.com ↗ |
| 2026-03-13 | Immutep S.A.S. | Results TACTI-004 Phase III Study in First Line NSCLC to be discontinued following Futility Analysis immutep.com ↗
Based on its review of the available safety and efficacy data, the IDMC recommended that the trial be discontinued for futility. |
| 2025-12-02 | Immutep S.A.S. | Results Immutep to Present New Data from AIPAC-003 Phase II at the 2025 San Antonio Breast Cancer Symposium immutep.com ↗
Time to onset of response (TTR) was comparable at 2.0 months (30 mg) versus 1.9 months (90 mg). |
| 2025-11-13 | Immutep S.A.S. | Results Translational Data and Significant Pathologic Response Rates from EFTISARC-NEO Phase II Highlighted in Oral Presentation at CTOS 2025 immutep.com ↗
In the evaluable patient population (N=38), the novel combination with efti reached a median 51.5% tumour hyalinization/fibrosis (p<0.001), meeting the study’s primary endpoint. |
| 2025-10-20 | Immutep S.A.S. | Results Two Posters at ESMO Congress 2025 Highlight Immutep’s Focus on Changing Treatment Landscape in First Line Non-Small Cell Lung Cancer immutep.com ↗
Notably, the ORR and DCR reported in INSIGHT-003 outperforms historical controls irrespective of PD-L1 levels. |
| 2025-10-20 | Immutep S.A.S. | Results Primary Endpoint Met in EFTISARC-NEO Phase II Evaluating Neoadjuvant Efti in Soft Tissue Sarcoma and Data Presented at ESMO Congress 2025 immutep.com ↗
In the evaluable patient population (N=38), the novel combination with efti reached a median 51.5% tumour hyalinization/fibrosis (p<0.001). |
| 2025-10-13 | Immutep S.A.S. | Regulatory Immutep Announces Successful Completion of FDA Project Optimus Requirements immutep.com ↗
today announces that positive and straightforward feedback has been received from the US Food and Drug Administration (“FDA”) regarding the successful completion of Project Optimus requirements and agreement on 30mg as the optimal biological dose for eftilagimod alfa (efti). |
| 2025-05-26 | Immutep S.A.S. | Results Immutep’s Efti with Radiotherapy & KEYTRUDA® (pembrolizumab) Meets Primary Endpoint in Phase II for Soft Tissue Sarcoma immutep.com ↗
The novel combination significantly exceeded the study’s prespecified median of 35% tumour hyalinization/fibrosis versus 15% for historical data from radiotherapy alone in patients with resectable soft tissue sarcoma (STS). |
| 2025-05-15 | Immutep S.A.S. | Results Immutep’s Efti with KEYTRUDA® (pembrolizumab) & Chemotherapy Achieves High Response Rates in First-Line Non-Small Cell Lung Cancer immutep.com ↗
today announces that a 60.8% response rate and 90.2% disease control rate, according to RECIST1.1, has been achieved in the investigator-initiated INSIGHT-003 trial as of the data-cut off date of 06 May 2025. |
| 2025-05-05 | Immutep S.A.S. | Results Immutep’s Efti in Combination with KEYTRUDA® (pembrolizumab) Drives Strong Overall Survival in Head and Neck Cancer with CPS <1 immutep.com ↗
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. |
| 2024-07-11 | Immutep S.A.S. | Results Immutep Reports Positive Results in First Line Head and Neck Squamous Cell Carcinoma Patients with Negative PD-L1 Expression immutep.com ↗
Efti in combination with KEYTRUDA® (pembrolizumab) achieved a 35.5% response rate in evaluable patients (N=31), according to RECIST 1.1, among the highest recorded for a treatment approach not containing chemotherapy in patients with CPS <1 |
| 2024-06-27 | Immutep S.A.S. | Results Immutep Reports Positive Topline Results from TACTI-003 Phase IIb Trial in First Line Head and Neck Cancer immutep.com ↗
Efti in combination with KEYTRUDA® (pembrolizumab) in first line head and neck squamous cell carcinoma (1L HNSCC) led to overall response rates that exceed KEYTRUDA monotherapy across all levels of PD-L1 expression |
All press releases naming this drug 19 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | eftilagimod alfa | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06726265 ↗ |
| Known as | Efti | “Eftilagimod Alfa (Efti) will be administered subcutaneously at a dose of 30 mg beginning of week 1 of the trial for a total of 3 doses (week 1, 2 and 3).” NCT07102940 ↗ |
| Action | Activate | “Eftilagimod alfa (efti) activates antigen-presenting cells, triggering T cell activation and a sustained immune response.” PMID 41383151 ↗ Dec 2025 |
| Modality | Protein / enzyme biologic | “a soluble LAG-3 protein, eftilagimod alfa (Efti)” NCT06128863 ↗ |
| Route | Subcutaneous | “Eftilagimod alfa 20 mg s.c. every 2 weeks (5 doses)” NCT06128863 ↗ |