Immutep has expanded the INSIGHT-003 trial of eftilagimod alpha (efti) plus anti-PD-1 therapy Keytruda (pembrolizumab) and doublet chemotherapy (carboplatin and pemetrexed) to treat non-squamous non-small cell lung cancer (NSCLC) to four sites in Germany.
The sites include the Lung Clinic Cologne-Merheim and the University Clinic of Ruhr Universität Bochum.
The expansion of sites will support quicker enrolment of subjects in the investigator-initiated trial assessing the triple combination therapy for first-line treatment of NSCLC.
Conducted by the Frankfurt Institute of Clinical Cancer Research IKF, the trial is being carried out as the third arm (Stratum C) of the ongoing Phase I INSIGHT study with professor Dr Salah-Eddin Al-Batran serving as lead investigator.
The study is designed to evaluate the tolerability, safety and initial efficacy of the combination.
Favourable results from the early clinical data in this study prompted an increase to 50 patients.
The extension started in the middle of this year, and so far, 29 patients have been enrolled.
With the launch of the new sites, the study is anticipated to conclude recruitment in the first half of next year.
The INSIGHT-003 triple combination achieved an overall response rate of 70.6% and 10.9-month median progression-free survival in subjects with PD-L1 Tumour Proportion Score (TPS) of less than 50%.
This shows positive results when compared to data from a similar group of patients, including a 40.8% response rate in a registration trial involving anti-PD-1 and doublet chemotherapy.
The triple combination was also found to be well tolerated.
In May, Immutep received the Paul-Ehrlich-Institut (PEI), German Federal Institute for Vaccines and Biomedicines approval to begin the INSIGHT-005 Phase I trial of eftilagimod alpha (efti) along with BAVENCIO (avelumab) to treat metastatic urothelial carcinoma, the most common bladder cancer type.
