Geneva – November 06, 2026 -- iOnctura's chemo-free regimen of roginolisib plus dostarlimab produced grade 3 or higher treatment-emergent adverse events in 35% of patients with immunotherapy-resistant non-small cell lung cancer (NSCLC), against 75% in the chemotherapy-containing control arm, according to late-breaking Phase I/II PULMO-01 data presented at the SITC 2026 Annual Meeting.
The triplet arm, which added docetaxel to roginolisib and dostarlimab, recorded a 69% rate. No fatal adverse events were attributed to roginolisib.
PULMO-01 randomized 49 patients across three regimens
The open-label study enrolled patients with advanced or metastatic non-squamous NSCLC whose disease progressed after checkpoint-inhibitor-based treatment. Sixteen patients received the triplet of roginolisib, dostarlimab and docetaxel. Seventeen received the chemo-free combination of roginolisib and dostarlimab. Sixteen received dostarlimab plus docetaxel as the control. Recruitment closed in December 2025.
The primary endpoints are the safety of the combinations and the proportion of patients with a reduction in peripheral blood regulatory T cells (Tregs) in each arm.
Roginolisib arms cut activated Tregs and expanded stem-like CD8+ T cells
In both roginolisib-containing arms, activated Tregs decreased and stem-like TCF1+ CD8+ central memory T cells increased. The changes were most pronounced and sustained in the chemo-free arm. Roginolisib is described as the first conformation-selective PI3Kδ inhibitor, locking the enzyme in its inactive state.
Response rates stay low as survival data remain immature
Confirmed partial responses came in one patient (6%) in the triplet arm, two (12%) in the chemo-free arm and two (13%) in the control arm. The company called low response rates expected in this treatment-refractory population.
Clinical benefit lasting at least six months reached 31% in the triplet arm, 24% in the chemo-free arm and 19% in the control arm.
As of September 30, 2026, at a median follow-up of 6.4 months, six-month overall survival was 60.9% for the triplet arm, 74.8% for the chemo-free arm and 43.8% for the control arm. The study was not designed to compare survival between arms, and follow-up continues.
CEO links results to a potential chemo-free option
iOnctura CEO and co-founder Catherine Pickering said the strongest immune effects came with the best-tolerated regimen, supporting a potential future chemo-free option for patients whose tumors resist checkpoint inhibitors.
The data were presented as poster abstract 1181 on November 6, 2026. Beyond lung cancer, roginolisib is in the randomized Phase II OCULE-01 study in uveal melanoma, which completed recruitment in January 2026, and the HEMA-MED Phase I/II study in myelofibrosis, where recruitment is ongoing.