Immutep (ASX:IMM) has announced that a 60.8 per cent response rate and 90.2 per cent disease control rate have been achieved in the investigator-initiated INSIGHT-003 trial as of the data-cut-off date of 6 May.
The trial is evaluating Immutep's eftilagimod alpha (efti) in combination with MSD's anti-PD-1 therapy, KEYTRUDA (pembrolizumab) and doublet chemotherapy as first-line treatment for patients with advanced or metastatic non-squamous non-small cell lung cancer (1L NSCLC).
Immutep's efti is a soluble LAG-3 protein and MHC Class II agonist that stimulates both innate and adaptive immunity for the treatment of cancer. The INSIGHT-003 trial is an investigator-initiated study conducted by the Frankfurt Institute of Clinical Cancer Research IKF and several other German centres.
The company said the 60.8 per cent response rate, regardless of PD-L1 expression, represents a substantial improvement compared to the historical control of 48.0 per cent. It noted that the relative outperformance is particularly strong, given that the registrational trial has four times as many patients with high PD-L1 expression.
Immutep CEO Marc Voigt said, “Our level of confidence in efti driving a new standard of care for patients with non-small cell lung cancer via our pivotal TACTI-004 trial continues to rise with the strength of the data from INSIGHT-003 and TACTI-002. Across two trials we have now efficacy data from 165 patients with 1L NSCLC who have been treated with efti and KEYTRUDA, either with or without chemotherapy. In multi-national settings, efti has generated consistent and remarkable improvements in response rates. In particular, the interim ORR data in patients with PD-L1 expression below 50% in the ongoing INSIGHT-003 trial, who represent over two-thirds of the 1L NSCLC patient population, is very encouraging.”