Clinical-stage company Immutep (ASX:IMM) has announced positive data from the investigator-initiated INSIGHT-003 Phase 1 trial evaluating its eftilagimod alpha (efti) in combination with MSD's KEYTRUDA (pembrolizumab) and chemotherapy for first-line treatment of metastatic non-squamous non-small cell lung cancer (1L NSCLC).
Professor Dr Salah-Eddin Al-Batran of the Frankfurt Institute of Clinical Cancer Research and project lead said, “The strength of these mature survival results coupled with a favourable safety profile in first-line treatment of patients with non-squamous NSCLC, the vast majority of whom have negative or low PD-L1 expression, is very encouraging. This promising data in INSIGHT-003 suggests a complementary effect from the addition of efti, a unique MHC Class II agonist, to the standard-of-care combination of pembrolizumab and chemotherapy which has revolutionised the treatment landscape in lung cancer. The IKF will also support and is looking forward to participating in the upcoming TACTI-004 study, which has PFS and OS as dual primary endpoints.”
The survival data from the triple combination therapy in 21 patients, irrespective of PD-L1 expression with a minimum follow-up of 22 months at data cut-off, revealed a median overall survival of 39.2 months and a median progression-free survival of 12.7 months.
Immutep CEO Marc Voigt said, “The overall survival and progression-free survival data from this mature cohort of patients in INSIGHT-003 with nearly a 2-year minimum follow-up exceeds our expectations. We are encouraged to see efti build upon the historical clinical outcomes from the most widely used immunotherapy-chemo combination today. Additionally, the early evaluations in the expansion cohort of 19 patients, who all have low or negative PD-L1 expression, are tracking well and we look forward to additional data updates from the INSIGHT-003 trial in 2025 and beyond. Our focus on potentially driving a new standard of care globally in first-line treatment of NSCLC is boosted by these results, and we are well advanced in our preparations to initiate the TACTI-004 Phase III trial.”