High Response Rates achieved in Lung Cancer in INSIGHT-003

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Stock Immutep Ltd (IMM.ASX)
Release Time 15 May 2025, 8:16 a.m.
Price Sensitive Yes
 Immutep's Efti Achieves High Response Rates in Lung Cancer Trial
Key Points
  • 60.8% response rate and 90.2% disease control rate in first-line non-small cell lung cancer
  • ~92% of patients have PD-L1 TPS <50%, including 43% with PD-L1 below 1
  • Significant improvement in response rates compared to historical controls
Full Summary

Immutep Limited announced that the investigator-initiated INSIGHT-003 trial evaluating eftilagimod alpha (efti) in combination with the anti-PD-1 therapy, KEYTRUDA (pembrolizumab) and doublet chemotherapy as first-line treatment for patients with advanced or metastatic non-squamous non-small cell lung cancer (1L NSCLC) has achieved a 60.8% response rate and 90.2% disease control rate, according to RECIST1.1. Notably, ~92% of all evaluable patients have PD-L1 Tumour Proportion Score (TPS) <50%, including 49% of patients with PD-L1 TPS of 1-49% and 43% of patients with PD-L1 TPS <1%, representing an area of high unmet need. The data demonstrates significant improvement in response rates compared to historical controls, with a 75.0% ORR versus 62.1% ORR in patients with high PD-L1 expression (TPS >50%), 64.0% ORR versus 49.2% ORR in patients with low PD-L1 expression (TPS 1-49%), and 54.5% ORR versus 32.3% ORR in patients with negative PD-L1 expression (TPS <1%). The safety profile continues to be favourable, and additional data updates from the INSIGHT-003 trial are expected to be presented at a medical conference in 2025 and beyond.

Guidance

No high-importance, price-sensitive forward-looking financial metrics or other company-specific metrics were provided in the announcement.

Outlook

The announcement states that additional data updates from the INSIGHT-003 trial are expected to be presented at a medical conference in 2025 and beyond.