iOnctura will present late-breaking clinical data on roginolisib in patients with immunotherapy-resistant non-small cell lung cancer (NSCLC) at the SITC 2026 annual meeting.

The poster will report findings from the ongoing PULMO-01 Phase 1/II study, which is evaluating the investigational PI3Kδ inhibitor in combination with dostarlimab, with or without docetaxel.

The presentation is scheduled for 6 November 2026 at the Society for Immunotherapy of Cancer (SITC) meeting in Phoenix, Arizona. The abstract is numbered 1181.

Roginolisib targets immune suppression in lung cancer

Resistance to immune checkpoint inhibitors remains a challenge in advanced NSCLC, particularly for patients whose disease progresses following treatment.

One mechanism associated with resistance involves regulatory T cells (Tregs), which suppress immune responses and can limit the ability of the immune system to recognise and attack cancer cells.

Roginolisib is a conformation-selective phosphoinositide 3-kinase delta (PI3Kδ) inhibitor designed to lock the enzyme in its inactive state.

According to iOnctura, the drug inhibits activated regulatory T cells while increasing memory-like CD8-positive T cells. These immune cells are involved in recognising and responding to cancer, making them an important focus of research into treatments designed to overcome immunosuppression.

The approach is intended to address the tumour immune environment that can contribute to resistance to checkpoint inhibitors.

Catherine Pickering, CEO and co-founder of iOnctura, said: “The acceptance of this late-breaking poster presentation at SITC reflects growing interest in novel approaches to addressing resistance to immunotherapy.”

She added: “We look forward to sharing new data that further characterizes the potential of our next-generation conformation-selective PI3Kδ inhibitor, roginolisib, for patients with non-small cell lung cancer.”

PULMO-01 evaluates roginolisib combinations

The open-label, randomised, parallel-arm PULMO-01 study (NCT06879717) is investigating roginolisib alongside dostarlimab, an immune checkpoint inhibitor, with or without the chemotherapy drug docetaxel.

The study has treated 49 patients with advanced or metastatic NSCLC whose disease progressed following standard-of-care immune checkpoint therapy.

Its primary objectives include evaluating the safety of the treatment combinations and the proportion of patients experiencing a reduction in peripheral blood regulatory T cells in each study arm.

Secondary endpoints include objective response rate, clinical benefit rate, progression-free survival and overall survival, alongside changes in immune cell subsets.

The study is designed to assess whether combining PI3Kδ inhibition with checkpoint blockade, with or without chemotherapy, can influence immune suppression and produce clinical activity in patients whose cancer has progressed following previous immunotherapy.

Late-breaking data to be presented at SITC 2026

The poster, titled ‘Roginolisib plus dostarlimab with or without docetaxel reverts immune suppression and shows clinical activity in immunotherapy-resistant non-small cell lung cancer (NSCLC)’, will be presented on Friday 6 November.

The late-breaking abstracts are scheduled for release at 9am ET that day.

The findings will provide further clinical information on roginolisib’s potential in a patient population with limited treatment options following progression on immune checkpoint inhibitor therapy.