Immutep’s Efti Combo Sparks Hope for Tough-to-Treat Lung Cancer Patients
Immutep’s novel immunotherapy combination with KEYTRUDA and chemotherapy shows promising response rates in first line non-small cell lung cancer, especially in patients with low or no PD-L1 expression.
- Eftilagimod alfa (efti) combined with KEYTRUDA and chemo achieves 61.7% response in low/no PD-L1 NSCLC
- INSIGHT-003 trial data outperform historical controls across all PD-L1 expression levels
- TACTI-004 Phase III trial underway to confirm efficacy in 756 global patients
- Efti’s mechanism activates both adaptive and innate immunity for broader cancer response
- Favorable safety profile and FDA Fast Track designation support clinical advancement
A New Hope in Lung Cancer Treatment
Immutep Limited has unveiled encouraging clinical data from its INSIGHT-003 trial, spotlighting a novel immunotherapy combination that could reshape first line treatment for non-small cell lung cancer (NSCLC). The combination of eftilagimod alfa (efti), KEYTRUDA (pembrolizumab), and chemotherapy demonstrated notably high objective response rates (ORR) and disease control rates (DCR) across all PD-L1 expression levels, a biomarker that often predicts response to immunotherapy.
What makes these results particularly compelling is the performance in patients with low or no PD-L1 expression; who historically respond poorly to PD-(L)1 inhibitors alone. In this subgroup, representing over two-thirds of the NSCLC population, the combination achieved a 61.7% ORR, significantly surpassing the 40.8% benchmark from historical controls. This suggests efti’s potential to expand the pool of patients benefiting from immunotherapy.
Mechanism and Clinical Promise
Efti is a unique immunotherapy that activates antigen-presenting cells through the MHC Class II pathway, bridging innate and adaptive immunity. This dual activation primes cytotoxic T cells and enhances immune signaling, potentially overcoming resistance seen in low PD-L1 tumors. The INSIGHT-003 trial, led by Dr. Akin Atmaca in Germany, reported strong safety and efficacy signals, reinforcing efti’s role as a promising adjunct to KEYTRUDA and chemotherapy.
Immutep’s CEO, Marc Voigt, emphasized confidence in efti’s ability to set a new standard of care, especially given the unmet need in patients with PD-L1 expression below 50%. The company is advancing this approach in the pivotal TACTI-004 Phase III trial, enrolling approximately 756 patients worldwide to validate these findings in a larger, more diverse population.
Looking Ahead
The TACTI-004 trial’s global scale and registrational intent underscore the strategic importance of this combination therapy. With a favorable safety profile and FDA Fast Track designation for both NSCLC and head and neck cancers, efti is positioned to become a versatile player in oncology immunotherapy. However, while the interim data are promising, the oncology community awaits final Phase III results to confirm overall survival benefits and regulatory approvals.
As the landscape of lung cancer treatment evolves, Immutep’s approach could offer a meaningful advance for patients who currently have limited options. The company’s progress will be closely watched by investors and clinicians alike, eager to see if efti can deliver on its early promise.
Bottom Line?
Immutep’s efti combo could redefine lung cancer care; next up, pivotal Phase III results to prove its lasting impact.
Questions in the middle?
- Will the TACTI-004 Phase III trial confirm efti’s survival benefits across all PD-L1 levels?
- How will efti’s safety profile hold up in a larger, more diverse patient population?
- What competitive advantages might efti offer over other emerging immunotherapy combinations?
