iOnctura to present late-breaking data on roginolisib in immunotherapy-resistant NSCLC at SITC

• Data from the ongoing PULMO-01 clinical study to be presented on November 6, 2026, at SITC 2026
• Roginolisib is the first conformation-selective PI3Kδ inhibitor that locks the enzyme in its inactive state

CAMBRIDGE, Mass. and GENEVA and AMSTERDAM, Oct. 29, 2026 /PRNewswire/ -- iOnctura today announced that a late-breaking poster evaluating roginolisib in patients with immunotherapy-resistant non-small cell lung cancer (NSCLC) will be presented at the Society for Immunotherapy of Cancer (SITC) 2026 Annual Meeting, taking place November 4–8 in Phoenix, Arizona.

The late-breaking poster presentation will report data from the ongoing PULMO-01 study evaluating the novel PI3Kδ inhibitor roginolisib in combination with dostarlimab, with or without docetaxel, in patients with advanced or metastatic NSCLC whose disease has progressed following prior immune checkpoint inhibitor therapy or prior immune checkpoint inhibitor in combination with platinum-based chemotherapy.

Poster presentation details

• Title: Roginolisib plus dostarlimab with or without docetaxel reverts immune suppression and shows clinical activity in immunotherapy-resistant non-small cell lung cancer (NSCLC)
• Session date: Friday, November 6, 2026
• Location: PCC-North Building-Lower Level-Exhibition Halls 4-5-6
• Abstract number: 1181

Late-breaking abstracts will be announced at 9:00 a.m. ET on Friday, 6 November 2026.

Advancing a novel approach to overcoming immunotherapy resistance

Resistance to immune checkpoint inhibitors remains a major challenge in the treatment of advanced NSCLC. Infiltration of highly immunosuppressive regulatory T cells (Tregs) is a well-characterized mechanism of resistance to checkpoint inhibitor treatment. Roginolisib is a novel conformation-selective PI3Kδ inhibitor that inhibits activated Tregs and increases memory-like CD8+ T cells; a mechanism of action with potential to restore treatment sensitivity in NSCLC.

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

PULMO-01 is an ongoing Phase I/II open-label, randomized, parallel-arm study (NCT06879717) evaluating roginolisib in combination with dostarlimab, with or without docetaxel. The study treated 49 patients who progressed on standard-of-care immune checkpoint therapy. It is primarily investigating the safety of the combinations and the proportion of patients with a reduction in peripheral blood regulatory T cells in each arm. Secondary endpoints include objective response rate, clinical benefit rate, progression-free survival, overall survival and changes in immune cell subsets.

For more information contact:

iOnctura

Corporate Press Office:
press@iOnctura.com 

Optimum Strategic Communications

Mary Clark / Stephen Adams / Henry Williams
Tel: +44 203 821 6420
Email: ionctura@optimumcomms.com 

About iOnctura

iOnctura is a clinical-stage precision oncology company combating neglected and hard-to-treat cancers with a pipeline of first-in-class small molecules. The bold new treatments extend lives and improve healthspans, changing the outlook for patients and their families. Lead asset, roginolisib, is the first conformation-selective inhibitor targeting the inactive form of PI3Kδ. This novel binding mode allows for precise inhibition of PI3Kδ, delivering clinical activity without the detrimental tolerability seen with previous generations of inhibitors. Roginolisib is being investigated in multiple randomized Phase II studies in solid and hematological malignancies. iOnctura is headquartered in Amsterdam, The Netherlands with subsidiaries located in Geneva, Switzerland and Cambridge, MA, USA. iOnctura is backed by specialist institutional investors including Syncona, M Ventures, Inkef Capital, EIC Fund, VI Partners, Schroders Capital and XGEN Venture.

About roginolisib

Roginolisib is a non-ATP-competitive PI3Kδ inhibitor that stabilizes the catalytic C-terminal helix kα12, inducing an allosteric conformational shift that locks PI3Kδ in its inactive state and prevents ATP-mediated activation. This novel binding mode allows for precise inhibition of PI3Kδ, delivering clinical activity without the detrimental tolerability seen with previous generations of inhibitors. The PI3K signaling pathway is one of the most commonly dysregulated pathways across multiple cancer types. The potential of roginolisib has been validated by positive clinical signals in Phase I in solid tumor and hematological malignancies, including a doubling of overall survival compared to historical controls in rare eye cancer, uveal melanoma. The company has carefully designed its clinical portfolio to allow full development in uveal melanoma, while in parallel validating the program in larger market indications. 

The randomized Phase II OCULE-01 study in uveal melanoma (NCT06717126) completed patient recruitment in January 2026, the PULMO-01 study in non-small cell lung cancer (NSCLC) (NCT06879717) completed recruitment in December 2025 and the HEMA-MED Phase I/II study (NCT06887803) in myelofibrosis began in October 2025 and recruitment is ongoing.