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Eftilagimod alpha

Generic Name
Eftilagimod alpha
Clinical Trials
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BMS's Opdualag Shows Strong Early Performance as First LAG-3 Checkpoint Inhibitor for Melanoma

• Bristol-Myers Squibb's Opdualag, the first FDA-approved LAG-3 inhibitor combination, generated $58 million in second-quarter sales following its March approval for metastatic melanoma. • Clinical data shows Opdualag more than doubles progression-free survival compared to PD-1 monotherapy, positioning it as a potential new standard of care with anticipated EU approval in coming weeks. • BMS expects Opdualag to reach $4 billion in peak sales across multiple cancer indications, strengthening its immuno-oncology portfolio as competitors including Merck develop rival LAG-3 inhibitors.

Novel Chemo-Immunotherapy Approach Shows Promise for Advanced HPV-Negative Head and Neck Cancer

• A Phase 2 clinical trial at UChicago Medicine demonstrated that combining nivolumab immunotherapy with chemotherapy led to tumor shrinkage in 53% of advanced HPV-negative head and neck cancer patients. • The innovative treatment approach, which included response-adaptive chemo-radiation therapy, showed improved survival outcomes and reduced toxic side effects, particularly in patients who responded well to initial treatment. • Higher PD-L1 expression levels were associated with better treatment responses, suggesting its potential as a biomarker for predicting treatment outcomes in this patient population.

LAG-3 Immunotherapies Market Poised for Explosive Growth with Next-Generation Therapies Advancing Across Major Markets

• The LAG-3 next-generation immunotherapies market is projected to grow from $463.6 million in 2024 to $5.5 billion by 2035, driven by increasing solid tumor cases and expanding treatment options. • Bristol Myers Squibb's Opdualag (nivolumab/relatlimab) has established a foundation for LAG-3 therapies, with promising candidates from Merck, Regeneron, and Immutep advancing through clinical trials. • Biomarker-driven precision medicine and strategic regulatory support are accelerating development of novel LAG-3 therapies, including monoclonal antibodies, bispecific antibodies, and soluble LAG-3 molecules.

Immutep's EFTISARC-NEO Trial Completes Enrollment for Soft Tissue Sarcoma

• Immutep's EFTISARC-NEO Phase II trial, evaluating eftilagimod alpha with radiotherapy and Keytruda, has completed enrollment of 40 patients with resectable soft tissue sarcoma. • Early data presented at CTOS 2024 showed the triple combination significantly increased tumor hyalinization/fibrosis compared to radiotherapy alone, suggesting improved survival. • The treatment combination demonstrated a favorable safety profile, with no grade ≥3 toxicities related to eftilagimod alpha and pembrolizumab reported. • Further data updates from the EFTISARC-NEO trial are anticipated in 2025, offering potential advancements in soft tissue sarcoma treatment strategies.

INSIGHT-003 Trial Completes Enrollment, Evaluating Efti Combination in Non-Small Cell Lung Cancer

• The INSIGHT-003 trial, evaluating eftilagimod alpha (efti) with pembrolizumab and chemotherapy, has completed enrollment with approximately 50 patients. • Initial overall survival data from INSIGHT-003 showed a median OS of 32.9 months and a 24-month OS rate of 81.0% in treated patients. • The trial is being conducted across multiple sites in Germany, led by the Frankfurt Institute of Clinical Cancer Research IKF. • Further data updates from the INSIGHT-003 trial are anticipated in 2025 and beyond, offering potential advancements in NSCLC treatment.

Immutep Initiates Phase III Trial of Eftilagimod Alfa for First-Line Non-Small Cell Lung Cancer

• Immutep has commenced its Phase III TACTI-004 trial to evaluate eftilagimod alfa in combination with pembrolizumab and chemotherapy for first-line metastatic non-small cell lung cancer. • The global study will enroll approximately 750 patients across 150+ clinical sites in over 25 countries, with first patient enrollment expected in Q1 2025. • The trial's dual primary endpoints are progression-free survival and overall survival, aiming to establish a new standard of care for patients with metastatic NSCLC. • Regulatory approval has been granted by the Australian Therapeutic Goods Administration, with further approvals anticipated in the UK and other countries.

Aulos Bioscience Doses First Patient in Phase 2 NSCLC Trial of AU-007, Avelumab, and Aldesleukin Combination

• Aulos Bioscience has dosed the first patient in a Phase 2 trial evaluating AU-007, avelumab, and low-dose aldesleukin for non-small cell lung cancer (NSCLC). • The trial is a collaboration with Merck KGaA and focuses on second-line treatment for PD-L1+ NSCLC patients who have progressed after first-line checkpoint inhibitor therapy. • Preclinical data showed the combination of AU-007 with avelumab and IL-2 resulted in strong anti-cancer activity, including complete tumor eradication. • Aulos Bioscience plans to share preliminary data from this Phase 2 cohort in the first half of 2025.

Immutep's Efti Shows Promise Across Multiple Cancer Trials; Enters Phase III for NSCLC

• Immutep's pivotal TACTI-004 trial of eftilagimod alfa (efti) in first-line non-small cell lung cancer (1L NSCLC) has received regulatory approval, marking the company's transition to Phase III. • INSIGHT-003 trial data in 1L NSCLC demonstrates a 32.9-month median overall survival and an 81.0% 24-month overall survival rate, significantly outperforming historical controls. • TACTI-003 trial in first-line head & neck cancer (PD-L1 CPS <1) reported at ESMO IO 2024 shows a 67% 12-month overall survival rate, exceeding historical controls. • EFTISARC-NEO Phase II trial in soft tissue sarcoma shows a three-fold increase in tumor hyalinization, the trial's primary endpoint, compared to historical radiotherapy data.

Immutep's Eftilagimod Alpha Enhances Keytruda Efficacy in First-Line Lung Cancer

• Immutep's eftilagimod alpha, when combined with Merck's Keytruda, demonstrates improved survival rates in first-line lung cancer treatment, suggesting a potential new therapeutic approach. • The combination therapy targets the LAG-3 pathway, offering a novel strategy to enhance the effectiveness of Keytruda in treating lung cancer patients. • Further robust data is needed to validate these findings and to fully understand the clinical benefits of adding eftilagimod alpha to Keytruda in this setting.

Immutep Announces Positive Phase II Trial Results for Soft Tissue Sarcoma Treatment

• Immutep's Phase II clinical trial for soft tissue sarcoma treatment shows positive results, marking a potential advancement in managing this cancer. • The trial's favorable response warrants further investigation, suggesting progress in Immutep's immunotherapy research and development efforts. • Immutep's lead product, Efti, demonstrates potential in improving survival rates among non-small cell lung cancer patients from INSIGHT-003 trial. • The company completed patient enrollment for the Phase II AIPAC-003 clinical trial, evaluating eftilagimod alpha for metastatic breast cancer.

Immutep's Eftilagimod Alpha Shows Promise in Phase II Sarcoma Trial

• Immutep's eftilagimod alpha, combined with pembrolizumab and radiotherapy, demonstrates a significant increase in tumor hyalinization in soft tissue sarcoma patients. • Tumor hyalinization, a key predictor of overall survival, was notably increased compared to standard treatments, suggesting a potential breakthrough. • The Phase II trial results indicate a promising new therapeutic approach for this aggressive cancer, warranting further investigation. • The combination therapy represents a potential advancement in the treatment landscape for soft tissue sarcoma, addressing an unmet medical need.

Immutep's Phase II Sarcoma Trial Shows Promising Results

• Immutep reported encouraging Phase II trial results for its sarcoma treatment, potentially offering a new option for patients with this challenging cancer. • The trial assessed the safety and efficacy of Immutep's drug in combination with another therapy, demonstrating a manageable safety profile. • These findings suggest a potential advancement in sarcoma treatment, warranting further investigation in larger studies to confirm the benefits. • The positive outcome could lead to improved outcomes for sarcoma patients, addressing a significant unmet need in oncology.

Immutep's Efti Plus Pembrolizumab and Radiotherapy Shows Promise in Soft Tissue Sarcoma

• A Phase II trial of eftilagimod alpha (efti) combined with pembrolizumab and radiotherapy demonstrates significant efficacy in neoadjuvant treatment of soft tissue sarcoma. • The triple combination therapy led to a greater than three-fold increase in tumor hyalinization/fibrosis compared to historical results from radiotherapy alone. • 71.4% of patients achieved a pathologic response, defined as ≥35% hyalinization/fibrosis, with 9.5% achieving a complete pathologic response in the EFTISARC-NEO trial. • The triple combination therapy was found to be safe, with no grade ≥3 toxicities related to efti and pembrolizumab reported.

Immutep's Eftilagimod Alpha Shows Promising Survival Data in NSCLC Trial

• Immutep's INSIGHT-003 trial reveals a median overall survival of 32.9 months in non-small cell lung cancer (NSCLC) patients treated with efti, pembrolizumab, and chemotherapy. • The study also demonstrated a median progression-free survival of 12.7 months and a 24-month overall survival rate of 81.0% in the same patient cohort. • Data from 40 evaluable patients showed a significant improvement in overall response rate compared to historical controls, with a favorable safety profile. • The INSIGHT-003 trial is nearing completion and its design mirrors the upcoming Phase III TACTI-004 trial, potentially establishing a new standard of care.

Immutep's Efti Plus Pembrolizumab and Radiotherapy Shows Promise in Soft Tissue Sarcoma

• Immutep's eftilagimod alpha (efti) combined with pembrolizumab and radiotherapy demonstrates significant efficacy in treating soft tissue sarcoma (STS). • The Phase II EFTISARC-NEO trial showed a threefold increase in tumor hyalinization compared to historical radiotherapy results, indicating improved outcomes. • The encouraging results highlight the synergistic potential of this novel therapeutic approach for patients with resectable soft tissue sarcomas. • These findings suggest a potential new treatment option for this rare and aggressive disease, addressing the critical need for more effective therapies.

Eftilagimod Alpha Combination Shows Promise in Soft Tissue Sarcoma

• A Phase II trial (EFTISARC-NEO) reveals that eftilagimod alpha combined with pembrolizumab and radiotherapy demonstrates significant efficacy in treating soft tissue sarcoma. • The triple combination therapy led to a threefold increase in tumor hyalinization, a key predictor of overall survival, compared to historical radiotherapy results. • Researchers express confidence in the synergistic effects of the therapeutic approach, highlighting its potential to address the unmet needs of patients with this aggressive disease.

Immutep Completes Enrollment in Phase II AIPAC-003 Trial for Metastatic Breast Cancer

• Immutep has completed patient enrollment in the Phase II portion of the AIPAC-003 trial, which is evaluating eftilagimod alpha (efti) in metastatic breast cancer. • The trial enrolled 65 patients with metastatic breast cancer who had exhausted endocrine therapy, including CDK4/6 inhibitors, across 22 sites in Europe and the US. • The study aims to determine the optimal biological dose of efti in combination with paclitaxel, aligning with the FDA's Project Optimus initiative. • Patients were randomized 1:1 to receive either 30mg or 90mg of efti, and further updates will be provided after data collection and analysis.

Immutep's Efti Shows Promise in Neoadjuvant Soft Tissue Sarcoma Treatment

• Immutep's EFTISARC-NEO Phase II trial evaluates eftilagimod alpha (efti) with radiotherapy and pembrolizumab in soft tissue sarcoma patients. • Initial data from the trial shows encouraging results, with deep responses observed in the majority of the first six patients. • The EFTISARC-NEO trial is the first to assess efti in a neoadjuvant setting, allowing for assessment of its impact on the tumor microenvironment. • The trial is being conducted at the Maria Skłodowska-Curie National Research Institute of Oncology in Warsaw and is funded by a Polish government grant.

Perioperative Pembrolizumab Demonstrates Survival Benefits in Early-Stage NSCLC and Advanced HNSCC

• A Phase III trial (KEYNOTE-671) showed that perioperative pembrolizumab significantly improves overall survival in patients with resectable, early-stage non-small cell lung cancer (NSCLC). • In NSCLC, 71% of patients receiving pembrolizumab were alive after 36 months, compared to 64% in the placebo group, with median event-free survival of 47 months versus 18 months, respectively. • KEYNOTE-689 trial results indicate that perioperative pembrolizumab improves event-free survival in patients with stage III/IVA resected head and neck squamous cell carcinoma (HNSCC). • KEYNOTE-689 marks the first positive trial in 2 decades for patients with resected, locally advanced HNSCC, potentially changing clinical practice.

Immutep Announces Positive Preliminary Topline Results from TACTI-003 Cohort B

Immutep Limited has revealed encouraging preliminary topline results from Cohort B of the TACTI-003 Phase IIb trial, showing a 26.9% response rate in first-line head and neck squamous cell carcinoma patients with negative PD-L1 expression. The study evaluates the combination of eftilagimod alpha (efti) with MSD’s anti-PD-1 therapy KEYTRUDA®.
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