Immutep Post Mautre Overall Survival Data In First-Line NSCLC; Updates On TACTI-004 Analysis

(RTTNews) - Immutep Limited (IMMP), a biotechnology company developing novel immunotherapies announced encouraging results from the investigator-initiated INSIGHT-003 Phase I trial in first-line non-squamous non-small cell lung cancer. The study evaluated eftilagimod alfa in combination with Merck's KEYTRUDA and chemotherapy.

About the Drug

Eftilagimod alfa (efti) is a novel immunotherapy that activates antigen-presenting cells via the MHC Class II pathway, engaging both adaptive and innate immunity. It is under evaluation in multiple solid tumors, including NSCLC, head and neck cancer, soft tissue sarcoma, and breast cancer, and has received FDA Fast Track designation in first line NSCLC and HNSCC.

Indication

Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for around 85% of cases. Patients with advanced, non-squamous NSCLC often face limited treatment options, particularly those with low or no PD-L1 expression, where response rates to checkpoint inhibitors are typically reduced. The combination of Efti with KEYTRUDA and chemotherapy is being explored to improve outcomes in this patient group by enhancing immune activation and extending survival.

INISGHT-003 Results

With a minimum of 30 months of follow-up, median Overall Survival (mOS) reached 30.9 months across 51-patient population, including those with low or no PD-L1 expression (Tumor Proportion Score less than 50%). This compares favorably to historical benchmarks of 22.0 months for anti-PD-1 plus chemotherapy.

Importantly, 92% of patients in the trial had low PD-L1 expression, a group that typically responds less well to PD-L1 inhibitor-based therapies. No new safety signals were observed.

TACTI-004 Update

In contrast, the company's Phase III TACTI-004 trial was discontinued earlier this year following a futility analysis. The objective response rate in the efti arm was 42.9% compared with 55.1% in the control arm. Immutep is conducting a root cause analysis to understand the differences, including immune activation profiles, with additional results expected in Q3 2026.

Management Commentary

Marc Voigt, CEO of Immutep, said the mature overall survival data from INSIGHT-003 reinforce confidence in efti's potential to enhance anti-tumor immune responses, particularly in patients with low PD-L1 expression. He added that the ongoing analysis of TACTI-004 is providing valuable insights to guide future development.

IMMP has traded between $0.29 and $3.53 over the past year. The stock closed Monday's trading at $0.45, up 7.52%. During the overnight trading the stock is at $0.43, down 2.51%.