Immutep (IMM) Bell Potter Healthcare Conference 2025 summary

Lead drug candidate and clinical progress

• Lead drug candidate eftilagimod alpha is in a global phase III trial for non-small cell lung cancer, aiming to change first-line treatment standards and improve patient survival.

• The phase III trial involves 756 patients across more than 150 hospitals in over 25 countries, with a one-to-one randomization between eftilagimod and placebo, both combined with standard of care.

• Recruitment is on track, with a futility analysis expected in Q1 next year and final progression-free survival readout anticipated between late 2026 and mid-2027.

• Prior phase I/II trials, including INSIGHT-003, showed a 61.7% response rate in patients not optimally responding to Keytruda, with median overall survival of 32 months and progression-free survival of 12 months.

• Collaboration with Merck provides Keytruda supply and input on trial design, ensuring industry-standard execution and regulatory engagement.

Market opportunity and trial design

• The addressable market for anti-PD-1 therapies in lung cancer is currently up to $25 billion annually, projected to exceed $40 billion by the early 2030s.

• The phase III trial uses stratification factors such as TPS score, region, patient performance status, and histology to ensure balanced recruitment.

• Co-primary endpoints are progression-free survival and overall survival, with regulatory filings possible after achieving statistical significance in either endpoint.

• The trial is designed to allow multiple opportunities for success, reducing binary risk and enabling subgroup analyses for regulatory discussions.

Pipeline and additional indications

• Eftilagimod alpha is also being evaluated in soft tissue sarcoma, where a recent trial met its primary endpoint with highly significant results and strong biomarker correlation.

• Additional data from metastatic breast cancer and soft tissue sarcoma trials are expected by year-end.

• IMP761, a separate LAG-3 candidate for autoimmune diseases, is in phase I dose escalation, showing promising early immunosuppressive effects in healthy volunteers.

• Target indications for IMP761 may include rheumatoid arthritis, psoriasis, and potentially type 1 diabetes.