Efti with KEYTRUDA Achieves 60.8% Response Rate in First-Line NSCLC
Immutep’s novel immunotherapy combination with KEYTRUDA and chemotherapy shows a 60.8% response rate in first-line non-small cell lung cancer, outperforming historical benchmarks especially in patients with low PD-L1 expression.
- 60.8% overall response rate and 90.2% disease control rate in INSIGHT-003 trial
- Strong efficacy in patients with PD-L1 expression below 50%, addressing high unmet need
- Triple combination therapy shows improved outcomes versus historical controls
- Favourable safety profile with no new adverse signals reported
- Additional data expected later in 2025 from ongoing trials
Promising Interim Results in Lung Cancer Treatment
Immutep Limited has announced encouraging interim data from its INSIGHT-003 clinical trial, evaluating efti (eftilagimod alpha) combined with KEYTRUDA (pembrolizumab) and chemotherapy as a first-line treatment for advanced non-small cell lung cancer (NSCLC). The combination achieved a 60.8% overall response rate (ORR) and a 90.2% disease control rate (DCR), marking a significant improvement over historical response rates for similar patient populations.
This trial is particularly notable because it focuses on patients with low PD-L1 expression, a biomarker associated with poorer responses to immunotherapy. Approximately 92% of evaluable patients had PD-L1 Tumour Proportion Scores (TPS) below 50%, including 43% with TPS under 1%, a group traditionally underserved by existing treatments.
Addressing a High Unmet Need
Patients with PD-L1 expression below 50% represent over two-thirds of the first-line NSCLC population and have historically experienced lower response rates to immunotherapy. In this subgroup, the triple combination therapy demonstrated a 59.6% ORR compared to a 40.8% historical control, suggesting efti’s potential to elevate outcomes where few options exist.
CEO Marc Voigt highlighted the consistency of these results across multinational studies, emphasizing the growing confidence that efti could establish a new standard of care in NSCLC. The data also aligns with findings from related trials, including TACTI-002 and the ongoing pivotal Phase III TACTI-004 study.
Safety and Next Steps
Safety data remain favourable, with no new safety signals emerging from the triple combination regimen. This is critical for patient tolerability given the intensity of combining immunotherapy with chemotherapy.
INSIGHT-003 is an investigator-initiated study led by the Frankfurt Institute of Clinical Cancer Research, and further data updates are anticipated at upcoming medical conferences in 2025. These forthcoming presentations will be closely watched by investors and clinicians alike, as they could solidify efti’s role in lung cancer treatment.
Broader Implications for Immunotherapy
Eftilagimod alpha is a first-in-class LAG-3 protein that activates antigen-presenting cells, stimulating both innate and adaptive immune responses. Its ability to enhance the efficacy of anti-PD-1 therapies like KEYTRUDA could have implications beyond lung cancer, with ongoing evaluations in head and neck cancers and metastatic breast cancer.
Immutep’s progress underscores the evolving landscape of immuno-oncology, where combination therapies are increasingly pivotal in overcoming resistance and improving patient outcomes.
Bottom Line?
As Immutep advances its pivotal trials, the oncology community awaits confirmation that efti can redefine first-line lung cancer treatment.
Questions in the middle?
- Will the pivotal TACTI-004 Phase III trial confirm these promising response rates?
- How will efti’s efficacy translate into overall survival and long-term outcomes?
- What regulatory pathways and market access strategies will Immutep pursue next?