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SYDNEY – Immutep Limited (ASX: IMM; NASDAQ: IMMP), an immunotherapy company with a market capitalization of $277 million, announced substantial interim trial results for a novel combination therapy treating non-small cell lung cancer (NSCLC). The INSIGHT-003 study, as of May 6, 2025, showed a 60.8% response rate and a 90.2% disease control rate in first-line treatment for advanced NSCLC using eftilagimod alpha (efti) with pembrolizumab and chemotherapy. According to InvestingPro data, the company maintains a strong balance sheet with more cash than debt, positioning it well for continued clinical development.
The study’s patient population mainly consisted of individuals with low PD-L1 expression, a group with fewer effective treatment options. Approximately 92% of the evaluable patients had PD-L1 Tumour Proportion Scores (TPS) below 50%, including 43% with TPS below 1%. This contrasts with historical controls, where patients with higher PD-L1 expression typically show better response rates to treatments.
The response rates across all levels of PD-L1 expression in the INSIGHT-003 trial demonstrated improvements over historical controls from a registrational trial that combined anti-PD-1 and chemotherapy. For instance, patients with TPS
Safety profiles for the triple combination therapy remain favorable, with no new safety signals reported. The company is preparing to present additional data from this trial at a medical conference later in 2025.
INSIGHT-003 is an investigator-initiated trial conducted by the Frankfurt Institute of Clinical Cancer Research and several other German centers. It is part of the ongoing Phase I INSIGHT trial, with Prof. Dr. Salah-Eddin Al-Batran as the lead investigator. Efti, the therapy being evaluated, is a soluble LAG-3 protein that stimulates the immune system and has received Fast Track designation from the FDA for first-line treatment in NSCLC and head and neck squamous cell carcinoma (HNSCC).
Immutep’s CEO, Marc Voigt, expressed confidence in efti’s potential to set a new standard of care for NSCLC patients, citing consistent improvements in response rates across various trials. While InvestingPro analysis shows the company is not yet profitable, with projected earnings per share of -$0.03 for FY2025, analysts have set price targets ranging from $7 to $12, suggesting significant upside potential. The company’s focus remains on developing treatments for cancer and autoimmune diseases, leveraging its expertise in LAG-3 therapeutics. Investors can access detailed financial analysis and 8 additional ProTips through an InvestingPro subscription.
This report is based on a press release statement from Immutep Limited. The company is currently trading below its Fair Value according to InvestingPro calculations, with expected revenue growth of 46% for FY2025. The next earnings report is scheduled for May 28, 2025, which could provide further insights into the company’s financial trajectory.
In other recent news, Immutep Ltd announced favorable results from its TACTI-003 Phase IIb trial, evaluating the combination of eftilagimod alfa and MSD’s KEYTRUDA® for patients with recurrent/metastatic head and neck squamous cell carcinoma. The trial reported a median Overall Survival (OS) of 17.6 months, which significantly exceeds the historical results from standard-of-care treatments that range from 7.9 to 11.3 months. This outcome suggests a potential new treatment option for patients with limited current therapies. The combination therapy was also well-tolerated, with no new safety concerns reported. Marc Voigt, CEO of Immutep, highlighted the significant survival benefit for patients with ’cold tumors,’ which typically respond poorly to immunotherapies. Immutep has received Fast Track designation for eftilagimod alfa and plans to consult with the U.S. Food and Drug Administration to discuss approval pathways. The company will continue its patient follow-up and data analysis, with further updates expected later in the year. These developments have been met with a positive reaction from investors, reflecting the potential clinical and commercial impact of the therapy.
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