This section highlights FDA-related milestones and regulatory updates for drugs developed by Prima BioMed (IMMP).
Over the past two years, Prima BioMed has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
eftilagimod and Eftilagimod. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
eftilagimod alpha - FDA Regulatory Timeline and Events
eftilagimod alpha is a drug developed by Prima BioMed for the following indication: For cancer and autoimmune disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- eftilagimod alpha
- Announced Date:
- May 27, 2025
- Indication:
- For cancer and autoimmune disease
Announcement
Immutep Limited announces the investigator-initiated EFTISARC-NEO Phase II trial evaluating eftilagimod alfa (efti) with radiotherapy plus KEYTRUDA® (pembrolizumab) in the neoadjuvant setting for resectable soft tissue sarcoma (STS) has met its primary endpoint.
AI Summary
Immutep Limited recently announced that its investigator-initiated EFTISARC-NEO Phase II trial has met its primary endpoint for patients with resectable soft tissue sarcoma. The trial combined eftilagimod alfa (efti) with radiotherapy and KEYTRUDA® (pembrolizumab) in the neoadjuvant setting before surgery. Researchers observed that the new treatment strategy not only exceeded the prespecified target of 35% tumor hyalinization and fibrosis but also performed significantly better than the 15% seen with radiotherapy alone.
Tumor hyalinization and fibrosis act as early indicators of treatment success, with higher levels linked to improved overall and recurrence-free survival. The encouraging results suggest that efti enhances the body’s immune response to transform the tumor environment, paving the way for stronger anti-cancer effects. Detailed findings will be presented at an upcoming medical meeting, marking an important step forward in the fight against this challenging cancer.
Read Announcement- Drug:
- eftilagimod alpha
- Announced Date:
- May 15, 2025
- Indication:
- For cancer and autoimmune disease
Announcement
Immutep Limited 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
AI Summary
Immutep Limited announced strong results from the INSIGHT-003 trial, reporting a 60.8% response rate and a 90.2% disease control rate according to RECIST1.1 evaluations as of May 6, 2025. The study investigates a combination treatment using eftilagimod alpha, pembrolizumab, and doublet chemotherapy as a first-line therapy for advanced or metastatic non-small cell lung cancer. Notably, the trial included many patients with low PD-L1 expression, an area with high unmet need, and the data demonstrate clear improvements over historical treatment results while maintaining a favorable safety profile.
These promising outcomes support further exploration of this immunotherapy strategy, and additional trial updates are expected to be presented at a forthcoming medical conference later this year.
Read Announcement - Drug:
- eftilagimod alpha
- Announced Date:
- January 22, 2025
- Indication:
- For cancer and autoimmune disease
Announcement
Immutep Limited announces that patient enrolment has been completed in the investigator-initiated EFTISARC-NEO trial. EFTISARC-NEO is evaluating eftilagimod alpha (efti) in combination with radiotherapy plus KEYTRUDA® (pembrolizumab) in the neoadjuvant setting for patients with resectable soft tissue sarcoma (STS).
AI Summary
Immutep Limited announced that the enrolment of patients in its investigator-initiated Phase II EFTISARC-NEO trial has been completed. The trial focuses on combining eftilagimod alpha (efti) with radiotherapy and KEYTRUDA® (pembrolizumab) as a neoadjuvant treatment for patients with resectable soft tissue sarcoma (STS). Conducted at the Maria Skłodowska-Curie National Research Institute of Oncology in Warsaw, Poland, the study has reached its target of 40 patients.
Early results from the trial have shown promising outcomes; the combination therapy increased tumor hyalinization/fibrosis three times compared to radiotherapy alone, a potential marker for improved survival in STS patients. Importantly, the treatment has been safe with no severe toxicities related to eftilagimod alpha or pembrolizumab. Further data from the EFTISARC-NEO trial are expected to be released in 2025.
Read Announcement- Drug:
- eftilagimod alpha
- Announced Date:
- January 22, 2025
- Indication:
- For cancer and autoimmune disease
Announcement
Immutep Limited announced that Data updates from EFTISARC-NEO expected in 2025
AI Summary
Immutep Limited announced that its EFTISARC-NEO trial has successfully enrolled 40 patients to study a new treatment approach for soft tissue sarcoma. The Phase II trial is testing eftilagimod alpha along with radiotherapy and KEYTRUDA® (pembrolizumab) in patients with resectable soft tissue sarcoma. Early findings showed a promising increase in tumor fibrosis, which is seen as a potential sign of improved patient outcomes. The trial has been conducted at a leading oncology center in Warsaw, Poland, and initial results suggest that the combination treatment is safe and may enhance the effects of radiotherapy.
The company highlighted that further data updates from the EFTISARC-NEO trial are expected in 2025. This upcoming information will help clarify the treatment’s benefits and guide future research in developing more effective immunotherapies for cancer patients.
Read Announcement- Drug:
- eftilagimod alpha
- Announced Date:
- January 6, 2025
- Indication:
- For cancer and autoimmune disease
Announcement
Immutep Limited announces that patient enrolment has been completed in the investigator-initiated INSIGHT-003 trial.
AI Summary
Immutep Limited announced that patient enrolment is now complete for the investigator-initiated INSIGHT-003 trial. This study evaluates eftilagimod alpha (efti) alongside pembrolizumab (KEYTRUDA®) and doublet chemotherapy as a first-line treatment for patients with advanced or metastatic non-squamous non-small cell lung cancer. The trial, led by the Frankfurt Institute of Clinical Cancer Research in Germany, has successfully enrolled about 50 evaluable patients across multiple clinical sites.
Early overall survival data from the INSIGHT-003 trial have already shown promising results, with a median overall survival of 32.9 months and an 81.0% survival rate at 24 months, compared to prior standard treatments. More data from the trial are expected to be released in 2025 and beyond, offering further insights into the potential benefits of this new combination therapy approach.
Read Announcement- Drug:
- eftilagimod alpha
- Announced Date:
- September 18, 2024
- Indication:
- For cancer and autoimmune disease
Announcement
Immutep Limited 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.
AI Summary
Immutep Limited announced that new data from its Phase II EFTISARC-NEO trial will be presented at the Connective Tissue Oncology Society (CTOS) 2024 Annual Meeting in San Diego, California from November 13 to 16, 2024. The trial is evaluating eftilagimod alpha (efti) in combination with radiotherapy and KEYTRUDA® (pembrolizumab) as a neoadjuvant treatment for patients with soft tissue sarcoma (STS), a hard-to-treat orphan disease with high unmet medical need.
This investigator-initiated study is the first to assess the effect of efti before surgery, allowing researchers to examine tumor tissue before and after treatment to better understand its impact on the tumor microenvironment. Early results from the trial have shown promising deep responses in patients, providing new hope in addressing the challenges of treating STS.
Read Announcement- Drug:
- eftilagimod alpha
- Announced Date:
- June 2, 2024
- Indication:
- For cancer and autoimmune disease
Announcement
Immutep Limited announced that it has entered into a clinical trial collaboration and supply agreement with MSD (Merck & Co., Inc., Rahway, NJ, USA), through a subsidiary, to evaluate eftilagimod alfa (efti) in combination with MSD's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) and chemotherapy for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) in a pivotal Phase III trial.
AI Summary
Immutep Limited has announced a new clinical trial collaboration and supply agreement with MSD, through its subsidiary, to evaluate eftilagimod alfa (efti) in combination with MSD’s anti-PD-1 therapy, KEYTRUDA®, and chemotherapy. The pivotal Phase III TACTI-004 trial will examine this combination as a first-line treatment for metastatic non-small cell lung cancer (NSCLC), aiming to set a new standard of care by enhancing treatment outcomes and expanding the pool of responsive patients.
The randomized, double-blind, multinational study will enroll approximately 750 patients, regardless of their PD-L1 expression levels. Immutep will manage the trial while MSD supplies KEYTRUDA®. The combination showed promising efficacy and a favorable safety profile in earlier studies, highlighting its potential to benefit a broader NSCLC population by overcoming current treatment limitations.
Read Announcement- Drug:
- eftilagimod alpha
- Announced Date:
- April 17, 2024
- Indication:
- For cancer and autoimmune disease
Announcement
Immutep Limited announces it has received positive feedback from the Spanish Agency for Medicines and Health Products (AEMPS) Competent Authority regarding the Company's upcoming TACTI-004 Phase III trial of eftilagimod alpha ("efti") for first line treatment of metastatic non-small cell lung cancer (1L NSCLC).
AI Summary
Immutep Limited announced that it has received positive feedback from Spain’s Agency for Medicines and Health Products (AEMPS) regarding its upcoming TACTI-004 Phase III trial. This trial will evaluate eftilagimod alpha (efti) as a first-line treatment for metastatic non-small cell lung cancer (1L NSCLC). The feedback from AEMPS supports Immutep’s plan to move forward with a registrational trial in Spain, a key region due to its active involvement in previous studies. Discussions with the agency covered important aspects of trial design, including the patient population, control arm selection, and statistical planning. The feedback highlights Spain’s involvement in the earlier Phase II study (TACTI-002), which investigated efti in combination with anti-PD-1 therapy. Immutep expressed gratitude for the constructive guidance provided, signaling further progress in their efforts to advance novel immunotherapy options for patients with 1L NSCLC.
Read Announcement
Eftilagimod alpha (efti or IMP321) MBC - FDA Regulatory Timeline and Events
Eftilagimod alpha (efti or IMP321) MBC is a drug developed by Prima BioMed for the following indication: Metastatic Breast Cancer (MBC).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Eftilagimod alpha (efti or IMP321) MBC
- Announced Date:
- November 14, 2024
- Indication:
- Metastatic Breast Cancer (MBC)
Announcement
- Immutep Limited announces the presentation of 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), at the Connective Tissue Oncology Society (CTOS) 2024 Annual Meeting.
AI Summary
Immutep Limited announced new results from its Phase II EFTISARC-NEO trial at the CTOS 2024 Annual Meeting. The study evaluated eftilagimod alpha (efti) combined with radiotherapy and KEYTRUDA® (pembrolizumab) as a neoadjuvant treatment for patients with soft tissue sarcoma (STS). Preliminary data from 21 patients showed that this triple therapy achieved a more than three‑fold increase in tumor hyalinization—reaching a median of 50% compared to the historical 15% seen with radiotherapy alone. Tumor hyalinization is an important indicator of overall survival, making these results especially promising. The trial’s principal investigators, Dr. Katarzyna Kozak and Dr. Paweł Sobczuk, expressed optimism about the treatment’s potential, highlighting its synergistic effects in improving outcomes for patients with this aggressive cancer.
Read Announcement
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