Immutep's INSIGHT-003 trial shows 30.9-month mOS in 1L NSCLC
Immutep Ltd. announced positive mature overall survival (mOS) data from its investigator-initiated INSIGHT-003 Phase I trial for eftilagimod alfa in combination with KEYTRUDA and chemotherapy for 1st line advanced non-small cell lung cancer (NSCLC). The trial demonstrated a mOS of 30.9 months in the overall population (N=51) and in patients with low PD-L1 expression (TPS <50%, N=47), comparing favorably to historical benchmarks of 22.0 months. No new safety signals were identified. The company also provided an update on the ongoing root cause analysis for the discontinued TACTI-004 Phase III trial, noting preliminary immune monitoring data indicating a different immune activation profile compared to previous studies, with additional results expected in Q3 CY2026.
Key Highlights
- INSIGHT-003 trial showed median Overall Survival (mOS) of 30.9 months (N=51).
- mOS was 30.9 months for patients with TPS <50% (N=47) in INSIGHT-003.
- mOS was 37.8 months for patients with TPS >=50% (N=4) in INSIGHT-003.
- Approximately 92% of INSIGHT-003 patients had TPS <50% PD-L1 expression.
- Historical benchmark mOS for similar treatment was 22.0 months.
- TACTI-004 efti arm ORR was 42.9% vs. control arm 55.1%.
- Additional TACTI-004 root cause analysis results expected in Q3 CY2026.
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