iOnctura Launches Promising Study into Treatment-Resistant Lung Cancer
iOnctura, a clinical-stage biopharmaceutical company, has announced the launch of a phase 1/2 clinical trial investigating its lead asset, roginolisib, in combination with dostarlimab, with or without docetaxel, in patients suffering from advanced non-small cell lung cancer (NSCLC).
This marks a significant milestone in the search for novel solutions for patients who no longer respond to standard immunotherapy treatments.
The trial has officially dosed its first patient, signalling the start of a focused investigation into whether this new combination can safely and effectively combat treatment resistance, one of the most urgent challenges in lung cancer care.
Addressing the Unmet Need in NSCLC
NSCLC is the most prevalent form of lung cancer, responsible for roughly one in five cancer-related deaths worldwide. Despite the availability of PD-1 or PD-L1 immunotherapy, often given alongside chemotherapy, many patients eventually develop resistance, leaving them with limited treatment options.
This trial, which will enrol approximately 45 patients, is designed to assess whether targeting PI3Kδ (phosphoinositide 3-kinase delta) with roginolisib could revitalise the immune system and potentially overcome or prevent immunotherapy resistance.
By combining this approach with dostarlimab – an anti-PD-1 agent – and possibly docetaxel chemotherapy, researchers hope to forge a new path for patients with advanced, treatment-refractory NSCLC.
Expert Insight and Trial Objectives
A professor of medical oncology, who is also a primary coordinating investigator of the trial, highlighted the urgency of the study, commenting that there is a significant lack of treatment options for NSCLC patients who have progressed on immunotherapy and chemotherapy.
Furthermore, they will be investigating whether the combination of roginolisib with dostarlimab and optional chemotherapy can be given safely and may offer a new treatment route for patients with limited alternatives.
Emerging clinical and preclinical data has provided encouraging signs that roginolisib, when used alongside PD-1/PD-L1 inhibitors, may deliver therapeutic benefit while preserving safety.
The study will not only assess clinical safety outcomes, but also explore reduction in regulatory T-cells in the bloodstream – a key factor in modulating the immune response in cancer patients.
Strategic Partnerships and Study Design
The study is an open-label, randomised trial, ensuring transparency in outcomes and allowing for adaptive learning as patient responses are monitored.
Under a supply agreement with GSK, dostarlimab will be provided for the trial, while iOnctura retains full global rights to roginolisib, positioning the company strongly for future development pathways.
This research builds on iOnctura’s growing reputation in immuno-oncology, with roginolisib at the forefront of its clinical pipeline.
A Step Forward in the Fight Against Lung Cancer
As treatment resistance continues to limit the success of current NSCLC therapies, iOnctura’s novel approach brings renewed hope for a vulnerable patient population.
By combining targeted immunomodulation with established checkpoint inhibitors, this trial could help lay the groundwork for next-generation treatments in oncology.
With the first patient now dosed and enrolment underway, the study marks an important chapter in precision medicine for NSCLC – ushering in the potential for safer, smarter, and more effective options for those most in need.
News Credits: iOnctura starts randomised phase 1/2 trial in lung cancer treatment
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