iOnctura’s roginolisib shows encouraging phase 1 results in metastatic uveal melanoma

iOnctura, a spinout of Merck KGaA, reported data from a two‑part phase 1 trial of its PI3K delta inhibitor roginolisib in patients with advanced solid and hematologic cancers, including a cohort of 20 patients with metastatic uveal melanoma.

In the combined 44‑patient population, the median overall survival was 20.8 months, markedly higher than the roughly seven‑month median reported historically for second‑line immunotherapy in similar patients. While the study lacked a placebo control, the survival gap suggests a potential benefit.

The safety profile was favorable, with no dose‑limiting toxicities or dose adjustments required. Grade 3 adverse events occurred in three patients, and the drug demonstrated predictable pharmacokinetics.

Biomarker analysis showed a reduction in regulatory T‑cell numbers and an increase in activated CD8+ T cells, indicating an immunomodulatory effect that may underlie the observed clinical activity.