Lycera has commenced a Phase lb clinical trial of LYC-55716 in combination with pembrolizumab (Keytruda) to treat patients with metastatic non-small cell lung cancer (NSCLC).

LYC-55716 is Lycera’s new immuno-oncology therapeutic candidate, and an oral, selective retinoic acid-related orphan receptor-gamma (RORgamma) agonist designed to reprogramme the immune system in patients with solid tumours.

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The new multi-centre Phase lb trial is expected to enrol around 18 patients with advanced, relapsed, or refractory NSCLC.

The trial will collect pre and post-treatment tumour biopsies, as well as blood samples. Its primary objective is to achieve safety and tolerability, while secondary endpoints include examination of immune biomarkers in tumour tissue and circulating immune markers in the blood, as well as objective response rate according to RECIST v1.1 criteria.

“PD-1 inhibition has completely changed oncology, but use of these agents alone appears to have convincing activity only in a minority of patients.”

US-based University of Colorado Cancer Centre Thoracic Oncology director Ross Camidge is appointed to be the investigator in the study.

Camidge said: “The oncology community is very interested in finding novel immunotherapy approaches that can stand alone or complement the activity of PD-1 inhibition.

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“PD-1 inhibition has completely changed oncology, but use of these agents alone appears to have convincing activity only in a minority of patients.

“Many different combinations of specific novel immunotherapies are being tried, but the challenge has been selecting which combination is right for which patient. In theory, the very broad immune reprogramming potential of RORgamma agonists is, therefore, very attractive to explore for synergy with PD-1 inhibition.”

Early safety and efficacy data from the Phase lb combination trial is expected to come out in the middle of 2019.

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