iOnctura starts randomised phase 1/2 trial in lung cancer treatment

Study explores whether PI3Kδ targeting could combat resistance

iOnctura has begun a randomized phase 1/2 study investigating its lead asset, roginolisib, in combination with dostarlimab, with or without docetaxel, in advanced non-small cell lung cancer (NSCLC).

The first patient has been dosed in the study, which aims to evaluate the safety of the drug combination and its potential in overcoming resistance to standard immunotherapy.

NSCLC is the most common type of lung cancer and accounts for around one in five cancer deaths globally. Current standard treatments include anti-PD-L1 or anti-PD1 immunotherapy, with or without chemotherapy, but many patients experience resistance over time. iOnctura’s study will assess whether targeting PI3Kδ could re-invigorate the immune system, preventing or reversing treatment resistance.

Michele Maio, MD, PhD, professor of medical oncology and primary coordinating investigator of the study said: ‘There is a significant lack of treatment options for NSCLC patients who have progressed on immunotherapy and chemotherapy.

We will be investigating whether the combination of roginolisib with dostarlimab and +/- chemotherapy can be given safely and may provide a novel treatment option in patients who no longer respond to their current treatment.’

Emerging data suggests that combining roginolisib with an anti-PD-L1/PD1 agent may help combat drug resistance in NSCLC while maintaining safety. Under a supply agreement, GSK will provide dostarlimab for the trial, while iOnctura retains worldwide rights to roginolisib.

The open-label, randomised study will enrol around 45 patients and assess the safety of the combination, alongside its impact on regulatory T-cell reduction in the bloodstream.