Immutep Terminates Phase III NSCLC Trial After Futility Analysis, Shares Dive 80%
Immutep halted its Phase III TACTI-004 trial of eftilagimod alfa plus pembrolizumab in frontline NSCLC after an IDMC deemed it unlikely to meet overall survival and progression-free survival endpoints. The biotech will stop enrolling patients, wind down the study and conduct a comprehensive data review as its shares plunged over 80% from $2.76 to $0.55.
1. Trial Termination and Details
Immutep terminated its Phase III TACTI-004 study of eftilagimod alfa plus pembrolizumab in frontline NSCLC after an independent data monitoring committee concluded the combination was unlikely to meet overall survival and progression-free survival endpoints. The company will cease enrolling new patients and wind down the trial after completing required follow-ups.
2. Previous Efti Data
In Phase II TACTI-003 head and neck cancer trials, efti plus pembrolizumab achieved a 34% overall response rate regardless of PD-L1 expression, but the candidate failed to meet progression-free survival and overall survival endpoints in the Phase IIb AIPAC breast cancer study.
3. Strategic Review and Future Plans
CEO Marc Voigt announced a comprehensive review of available data to understand the futility outcome and determine next steps. Immutep stated it remains focused on advancing efti across soft tissue sarcoma, non-squamous NSCLC, breast cancer and head & neck cancer indications.
4. Market Reaction
Following the IDMC recommendation, Immutep’s share price fell over 80% from $2.76 to $0.55 at market open, reflecting investor concern over efti’s efficacy and the program’s prospects.