Immutep announces expansion the INSIGHT-003 trial

Immutep announces it has signed an agreement to expand the INSIGHT-003 trial evaluating the combination of eftilagimod alpha, 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 1st line non- small cell lung cancer. 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. 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% and a Disease Control Rate of 90.9%. Patients with low to negative PD-L1 expression represent two-thirds of the 1L NSCLC patient population and are less responsive to anti-PD-(L)1 therapy compared to patients with a PD-L1 TPS of greater than or equal to50%. Unlike many dual immuno-oncology combinations that focus solely on high PD-L1 expressing patients, compelling clinical results to date suggest that efti may be uniquely positioned to address the entire NSCLC patient population regardless of PD-L1 expression through chemo-free IO-IO combinations or IO-IO-chemo triple combinations as INSIGHT-003 is evaluating. In addition to the Company’s late-stage clinical development efforts focused on 1L NSCLC with the combination of efti and anti-PD-1 therapy, the expansion of INSIGHT-003 will further inform planning for registrational studies. Importantly, this multi-center investigator-initiated trial will generate valuable data in a cost-efficient manner.