Clinical TrialJul 14, 2026, 06:07 AM
Immutep Reports Positive INSIGHT-003 NSCLC Data; TACTI-004 Analysis Ongoing
AI Summary
Immutep announced positive mature Overall Survival (mOS) data from its INSIGHT-003 Phase I trial for eftilagimod alfa (efti) in 1st line non-small cell lung cancer (NSCLC). The trial showed a mOS of 30.9 months in the overall population and in patients with low PD-L1 expression, comparing favorably to historical benchmarks. 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 indicated a different immune activation profile compared to previous studies. Additional results from the TACTI-004 analysis are expected in Q3 CY2026.
Key Highlights
- INSIGHT-003 Phase I trial showed a median Overall Survival (mOS) of 30.9 months in 1st line NSCLC.
- mOS was 30.9 months for patients with TPS <50% (N=47) and 37.8 months for TPS >=50% (N=4).
- These mature results compare favorably to historical benchmarks of 22.0 months mOS.
- TACTI-004 Phase III trial was discontinued in March 2026 following a futility analysis.
- Preliminary immune monitoring data from TACTI-004 indicated a different immune activation profile.
- Root cause analysis for TACTI-004 is ongoing, with additional results expected in Q3 CY2026.
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