Immutep Surpasses Enrollment Milestone in Pivotal Lung Cancer Trial

Clinical Trial Momentum Builds

Immutep Limited, a biotechnology company focused on immunotherapy, has reported significant progress in its clinical development programs during the first quarter of fiscal 2026. The pivotal Phase III TACTI-004 trial evaluating eftilagimod alfa (efti) in first-line non-small cell lung cancer (NSCLC) has exceeded a key enrollment milestone, randomizing over 170 patients across more than 100 clinical sites in 24 countries. This achievement surpasses the number required to conduct the planned futility analysis, expected in early 2026, marking a critical step toward potential regulatory approval.

Alongside this, Immutep continues to receive encouraging feedback from physicians and regulatory bodies. At the World Conference on Lung Cancer and the European Society for Medical Oncology Congress, the company presented trial progress and early data, reinforcing confidence in efti’s therapeutic potential when combined with Merck’s KEYTRUDA® and chemotherapy.

Expanding Indications and Regulatory Support

Beyond lung cancer, Immutep has advanced its pipeline in other oncology indications. Notably, the US Food and Drug Administration (FDA) has provided positive and constructive feedback on the late-stage development of efti for first-line treatment of head and neck squamous cell carcinoma (HNSCC) patients with low PD-L1 expression (CPS <1). The FDA’s support for further clinical development and potential accelerated approval pathways underscores the unmet need in this patient segment and validates Immutep’s strategic focus.

In breast cancer, a new investigator-initiated Phase II trial has been launched to evaluate neoadjuvant efti as monotherapy and in combination with chemotherapy in early-stage hormone receptor-positive, HER2-negative patients. This trial, led by The George Washington University Cancer Center, aims to assess pathological complete response rates and could open new avenues for efti’s application in earlier disease stages.

Intellectual Property and Financial Health

Immutep strengthened its intellectual property portfolio with four new patents granted during the quarter, including protections related to manufacturing assays and its autoimmune candidate IMP761. These patents enhance the company’s competitive moat and support long-term value creation.

Financially, Immutep maintains a robust cash position of approximately A$109.85 million, comprising cash, equivalents, and term deposits. This strong liquidity provides an expected cash runway through the end of calendar 2026, enabling continued investment in clinical trials and operational activities. Operating cash outflows increased slightly due to intensified clinical activity, but overall cash management remains prudent.

Looking Ahead

With multiple clinical programs progressing on schedule and regulatory engagement advancing, Immutep is well positioned to deliver key data readouts in the coming quarters. The upcoming futility analysis for the TACTI-004 trial and further data from head and neck and breast cancer studies will be critical catalysts. Investors and industry watchers will be closely monitoring these developments as Immutep seeks to translate its immunotherapy innovations into approved treatments.