Immutep Achieves 50% Enrollment in Pivotal Phase III Lung Cancer Trial
Summary
Immutep announced it has achieved 50% patient enrollment in its global TACTI-004 Phase III trial for first-line non-small cell lung cancer, evaluating eftilagimod alfa in combination with KEYTRUDA and chemotherapy.
Key Events
-
Phase III Enrollment Milestone Achieved
Immutep has enrolled 378 patients, reaching 50% of the targeted enrollment for its global TACTI-004 (KEYNOTE-F91) Phase III trial.
-
Pivotal Trial for Lung Cancer
The registrational trial evaluates eftilagimod alfa in combination with KEYTRUDA and chemotherapy as a first-line therapy for advanced/metastatic non-small cell lung cancer (1L NSCLC).
-
Upcoming Milestones On Track
Futility analysis remains on track for the first quarter of CY2026, with completion of patient enrollment expected in the third quarter of CY2026.
Analysis
Immutep's announcement of reaching 50% patient enrollment in its TACTI-004 Phase III trial is a significant positive operational milestone. This registrational trial for first-line non-small cell lung cancer (1L NSCLC) is critical for the company's lead immunotherapy, eftilagimod alfa. Achieving this halfway point demonstrates strong execution and keeps the trial on track for key upcoming milestones, including futility analysis in Q1 and full enrollment in Q3 CY2026. Successful progression in such a large indication could substantially de-risk the drug's development and future commercial potential.
At the time of this filing, IMMP was trading at $2.68 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $386.6M. The 52-week trading range was $1.32 to $3.53. This filing was assessed with positive market sentiment and an importance score of 7 out of 10.