Immutep Reports 32.9-Month Median Survival in NSCLC, Starts Phase III Trial
Immutep Limited has initiated its pivotal Phase III trial for eftilagimod alfa in first-line non-small cell lung cancer, supported by compelling survival outcomes from ongoing studies and a robust cash position expected to fund operations through 2026.
- Initiation of Phase III TACTI-004 trial in first-line metastatic NSCLC with regulatory approval
- INSIGHT-003 trial reports 32.9-month median overall survival and 81% 24-month OS rate
- Promising Phase IIb TACTI-003 data in head and neck cancer with PD-L1 CPS <1 patients
- Strong cash reserves of A$159.26 million ensuring funding through end of calendar 2026
- Favourable safety profile for IMP761 autoimmune program and new patents granted
Immutep’s Leap into Phase III
Immutep Limited (ASX: IMM; NASDAQ: IMMP) has marked a significant milestone by commencing its pivotal Phase III clinical trial, TACTI-004, evaluating eftilagimod alfa (efti) in first-line metastatic non-small cell lung cancer (1L NSCLC). Regulatory approval from the Australian Therapeutic Goods Administration has officially transitioned Immutep into a Phase III biotech company, underscoring the maturation of its LAG-3 immunotherapy pipeline.
The global trial is set to enroll patients across more than 25 countries, with initial patient recruitment anticipated in the first quarter of 2025. This advancement reflects Immutep’s growing footprint in oncology and its commitment to delivering novel immunotherapies targeting LAG-3, a key immune checkpoint molecule.
Compelling Survival Outcomes Bolster Confidence
In parallel, Immutep reported encouraging results from the TACTI-003 Phase IIb trial in first-line head and neck squamous cell carcinoma (HNSCC) patients with PD-L1 CPS <1, a subgroup typically resistant to anti-PD-1 therapies. The median OS has not yet been reached, with a 67% 12-month OS rate and a 35.5% objective response rate, highlighting the potential of efti combined with KEYTRUDA® (pembrolizumab) to improve outcomes in this difficult-to-treat population.
Expanding Clinical Horizons and Intellectual Property
Beyond lung and head and neck cancers, Immutep’s Phase II EFTISARC-NEO trial in soft tissue sarcoma revealed a three-fold increase in tumour hyalinization compared to historical radiotherapy data, a surrogate marker linked to survival. This triple combination therapy with efti, radiotherapy, and KEYTRUDA® was well tolerated, reinforcing Immutep’s broad therapeutic potential.
On the autoimmune front, the first-in-human Phase I trial of IMP761, an agonist LAG-3 antibody, reported favourable initial safety results, advancing Immutep’s novel approach to modulating immune responses in autoimmune diseases.
Immutep also strengthened its intellectual property portfolio with new patents granted in Brazil, Japan, and Malaysia, covering efti combinations and IMP761, which will support future commercialization and competitive positioning.
Financial Strength and Corporate Developments
Financially, Immutep is well positioned with a combined cash, cash equivalents, and term deposit balance of A$159.26 million as of December 31, 2024. This robust liquidity is expected to fund operations through the end of calendar 2026, despite increased R&D expenditure driven by the Phase III trial initiation and expanded clinical activities.
Corporate changes include the promotion of Christian Mueller to Chief Development Officer and the planned departure of Chief Medical Officer Dr Florian Vogl in April 2025, with Dr Stephan Winckels stepping in as acting CMO. These leadership adjustments coincide with the company’s transition into a more advanced clinical stage.
Bottom Line?
Immutep’s Phase III launch and strong survival data set the stage for pivotal readouts that could redefine LAG-3 immunotherapy’s role in oncology.
Questions in the middle?
- How will regulatory approvals progress across the 25+ countries involved in TACTI-004?
- What are the timelines and expectations for full data readouts from the Phase III trial?
- How might emerging safety and efficacy data from IMP761 influence autoimmune disease indications?
