Immutep (IMM) Baird's Biotech Discovery Series summary

Key clinical insights and trial results

• Eftilagimod alpha (efti) combined with Keytruda showed higher and more durable response rates in first-line head and neck cancer patients with PD-L1 <1%, compared to historical results for Keytruda alone, with minimal added toxicity.

• The durability of response in this population reached around nine months, with promising overall survival rates and no median overall survival reached yet.

• In Europe, patients with PD-L1 <1% have no approved first-line immunotherapy options, making these results particularly significant for an underserved group.

• Approximately 20% of first-line head and neck cancer patients fall into the PD-L1 <1% category, representing a substantial unmet need.

• Efti's mechanism targets antigen-presenting cells, differentiating it from other checkpoint inhibitors and potentially offering unique benefits.

Regulatory and development plans

• Fast-track designation has been granted for first-line head and neck cancer, with plans to discuss the regulatory path forward with the FDA and other agencies in the first half of 2025.

• Ongoing data collection and patient follow-up are priorities to support further development and regulatory submissions.

Phase III lung cancer trial and Merck collaboration

• A large, global phase III trial in first-line non-small cell lung cancer (NSCLC) is launching, in collaboration with Merck, using a double-blind, randomized design with dual primary endpoints: progression-free survival and overall survival.

• The trial will enroll about 750 patients across more than 25 countries and 150+ hospitals, targeting all first-line metastatic NSCLC patients eligible for anti-PD-1 therapy (TPS 0-100, squamous and non-squamous).

• Merck is supplying Keytruda for the trial, representing significant commercial value and a strong vote of confidence in the program.

• The trial includes interim and futility analyses, with the first patient expected in Q1 next year and interim data potentially available by late 2026.