Immutep Limited has signed an agreement to expand the INSIGHT-003 trial evaluating the combination of eftilagimod alpha (efti), a soluble LAG-3 protein and first-in-class MHC class II agonist, in conjunction with standard-of-care combination of anti-PD-1 therapy and chemotherapy in first-line non-small cell lung cancer (1L NSCLC).

INSIGHT-003 recently reached its initial enrolment target of 20 patients and will now be expanded to 50 patients across multiple sites. This expansion is based on favourable safety and strong initial efficacy results presented at SITC 2022. Additional data from INSIGHT-003 is expected throughout calendar year 2023.

Prof. Dr. Salah-Eddin Al-Batran of the Institute of Clinical Cancer Research IKF and lead investigator noted: “We’re thrilled to expand the trial population for this triple combination therapy, which has demonstrated promising efficacy and safety in first-line non-small cell lung cancer patients. We have seen the previous findings that are indicative of powerful synergies of efti’s immune system stimulation with anti-PD-(L)1 therapies and separately with chemotherapy across various solid tumors. As we continue to gather clinical data throughout the year, we eagerly anticipate discovering how this synergy translates in the INSIGHT-003 study, which combines all three modalities.”

Initial results from the triple combination of efti, an anti-PD-1 therapy and chemotherapy in patients with 1L NSCLC show that the therapy is well-tolerated and provides promising early signals of therapeutic activity with an ORR of 72.7 percent and a Disease Control Rate (DCR) of 90.9 percent.

Immutep CEO, Marc Voigt, said: “We are grateful for the long-standing support of Dr. Al-Batran and the entire team at IKF. Our valuable relationship with this world-class institution has uncovered many positive attributes of efti and continues to help us cost-effectively advance this novel immunotherapy for patients with advanced solid tumours, including 1st line non-small cell lung cancer.”