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.
Select a button below to view the list of FDA events for that drug.
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:
- April 15, 2026
- Indication:
- For cancer and autoimmune disease
Announcement
Immutep Limited announces that the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for eftilagimod alfa ("efti") for the treatment of Soft Tissue Sarcoma (STS), a rare cancer with significant unmet medical need.
AI Summary
Immutep Limited announced that the U.S. Food and Drug Administration has granted Orphan Drug Designation (ODD) to eftilagimod alfa (“efti”) for the treatment of Soft Tissue Sarcoma (STS). STS is a rare group of cancers with significant unmet medical need, and the ODD acknowledges efti’s potential role in treating patients who have limited options.
The FDA’s ODD program supports development of therapies for conditions affecting fewer than 200,000 people in the United States. Benefits can include regulatory support, potential tax credits, exemptions from certain fees, and, if approved, seven years of market exclusivity. This designation can help Immutep advance clinical development and may improve access to incentives that lower development costs and regulatory barriers for efti in STS.
Read Announcement- Drug:
- eftilagimod alpha
- Announced Date:
- October 20, 2025
- Indication:
- For cancer and autoimmune disease
Announcement
Immutep Limited announces two poster presentations at the European Society for Medical Oncology (ESMO) Congress 2025 highlight the Company's focus on changing the treatment paradigm in first line non-small cell lung cancer (1L NSCLC).
AI Summary
At the 2025 European Society for Medical Oncology (ESMO) Congress in Berlin, Immutep Limited will present two poster presentations that highlight the company’s focus on shifting the treatment paradigm in first-line non-small cell lung cancer (1L NSCLC).
The first poster, TACTI-003, offers Phase Ib data on eftilagimod alfa combined with pembrolizumab in treatment-naïve 1L NSCLC. The study reports encouraging response rates, improved progression-free survival, and robust immune activation.
The second poster, TACTI-004 (KEYNOTE-F91), outlines early findings from a pivotal Phase III trial evaluating eftilagimod alfa plus pembrolizumab in unresectable stage III/IV NSCLC. Data show a favorable safety profile and strong signs of antigen presentation.
By highlighting these posters, Immutep underscores its goal to transform first-line NSCLC care by boosting antigen presentation and exploring synergistic combinations, aiming to deliver more durable outcomes for patients facing this challenging disease.
Read Announcement- Drug:
- eftilagimod alpha
- Announced Date:
- October 13, 2025
- Indication:
- For cancer and autoimmune disease
Announcement
Immutep Limited 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).
AI Summary
Immutep Limited announced that it received positive and straightforward feedback from the FDA, confirming that the company has successfully completed the FDA’s Project Optimus requirements and agreeing that 30 mg is the optimal biological dose for eftilagimod alfa (efti). Project Optimus is the FDA’s initiative to ensure oncology drug doses are both safe and effective. This decision is a major de-risking event and lays a key foundation for future Biological License Application filings.
Chief Development Officer Christian Mueller said the alignment on the optimal dose is strategically important to Immutep’s oncology programs. He noted that this milestone builds confidence in efti’s development and brings the company closer to delivering a novel immunotherapy to cancer patients worldwide.
With the FDA’s agreement on dosing, Immutep is now advancing the global TACTI-004 (KEYNOTE-F91) Phase III trial in first-line non-small cell lung cancer. Clinical sites in the United States are in the process of opening, moving the program further toward potential approval.
Read Announcement- Drug:
- eftilagimod alpha
- Announced Date:
- September 22, 2025
- Indication:
- For cancer and autoimmune disease
Announcement
Immutep Limited announces the initiation of an investigator-initiated Phase II trial evaluating neoadjuvant eftilagimod alfa (efti) administered subcutaneously as monotherapy and then in combination with standard-of-care chemotherapy prior to surgery in patients with early-stage HR+/HER2-negative breast cancer.
AI Summary
Immutep Limited has launched an investigator-initiated Phase II trial at The George Washington University Cancer Center to test neoadjuvant eftilagimod alfa (efti) in early-stage HR+/HER2-negative breast cancer. Patients will receive efti subcutaneously as monotherapy for three weeks, followed by standard-of-care chemotherapy combined with efti before surgery.
The study plans to enroll up to 50 evaluable patients in a two-stage design. It is primarily funded by grants and the GW Cancer Center, while Immutep provides the efti doses at no cost, technical support, and limited funding. Principal Investigator Pavani Chalasani, MD, MPH, will lead the trial.
Efti is a first-in-class soluble LAG-3 protein that activates antigen-presenting cells and sparks a broad anti-cancer immune response. It boosts CD8+ T cells armed with chemotherapy-induced tumor antigens and other immune cells. The main goal is to measure pathologic complete response, with hopes of improving long-term disease-free survival in patients with stronger early-stage immune systems.
Read Announcement- Drug:
- eftilagimod alpha
- Announced Date:
- August 5, 2025
- Indication:
- For cancer and autoimmune disease
Announcement
Immutep Limited 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).
AI Summary
Immutep Limited announced positive and constructive feedback from the US FDA on its clinical plans for eftilagimod alfa (“efti”), a first-in-class MHC Class II agonist. The FDA reviewed data from the Phase IIb TACTI-003 (KEYNOTE-C34) trial combining efti with Merck’s KEYTRUDA® (pembrolizumab) in recurrent/metastatic head and neck squamous cell carcinoma (1L HNSCC) patients with PD-L1 combined positive score (CPS) below 1. Regulators agreed the combination shows promise for this underserved group and supports further study.
The FDA outlined two development paths under its Project FrontRunner initiative: a randomized registrational trial comparing efti plus KEYTRUDA against standard therapy, or a smaller single-arm study of about 70–90 patients focusing on safety, response rate and duration of response, followed by a confirmatory randomized trial. These options aim to speed development of a new therapy for up to 20% of 1L HNSCC patients who currently rely on chemotherapy.
Read Announcement- Drug:
- eftilagimod alpha
- Announced Date:
- July 28, 2025
- Indication:
- For cancer and autoimmune disease
Announcement
Immutep Limited announces three abstracts for clinical trials evaluating its first-in-class MHC Class II agonist, eftilagimod alfa (efti), have been accepted for presentation at the European Society for Medical Oncology (ESMO) Congress 2025 taking place 17-21 October in Berlin, Germany.
AI Summary
Immutep Limited, a late-stage immunotherapy company, will present three studies on its first-in-class MHC Class II agonist, eftilagimod alfa (efti), at the European Society for Medical Oncology (ESMO) Congress 2025 in Berlin from October 17–21.
A Proffered Paper will detail results from the Phase II EFTISARC-NEO trial in resectable soft tissue sarcoma. A poster will show updates from the INSIGHT-003 Phase I trial combining efti with first-line chemo-immunotherapy in metastatic non-squamous non-small cell lung cancer. A Trials in Progress ePoster will outline the pivotal TACTI-004 Phase III trial of efti plus pembrolizumab and chemotherapy versus placebo in first-line advanced/metastatic NSCLC.
These presentations highlight efti’s potential to improve patient outcomes across multiple cancer types. The abstracts will be available on the ESMO website on October 13, 2025, and the posters will appear on Immutep’s site after presentation. Immutep develops novel LAG-3-targeted therapies to boost the immune response against cancer and autoimmune diseases.
Read Announcement- 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
Eftilagimod alpha (efti or IMP321) MBC FDA Regulatory 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
