iOnctura achieves new clinical milestones in uveal melanoma therapy

Successful phase 1 study highlights potential of roginolisib

iOnctura has announced promising results from the phase 1 DIONE-01 study, showcasing the clinical activity and long-term safety of roginolisib in patients with uveal melanoma.

The data will be presented at the European Society for Medical Oncology Immuno-Oncology congress tomorrow.

“Roginolisib’s unique allosteric binding mechanism offers a differentiated beneficial clinical profile, doubling overall survival compared to historical controls,” said Catherine Pickering, CEO of iOnctura.

The study demonstrated that patients with uveal melanoma treated with roginolisib had a median overall survival of 16 months, significantly exceeding the 7 months observed with previous treatments.

The trial also confirmed that roginolisib was well tolerated at the recommended Phase II dose of 80mg, with less than 7% of patients experiencing grade 3/4 treatment-emergent adverse events. “The phase 1 DIONE-01 data highlight the benefits of roginolisib for patients with uveal melanoma and advanced cancers,” added Pickering.

Professor Michele Maio, Principal Investigator of the roginolisib studies, said, “Being able to continue to investigate roginolisib in a randomised phase 2 study is a positive step to understand more about this well tolerated molecule. Roginolisib has provided prolonged disease stabilization for patients who have exhausted all other therapeutic options.”

The findings support the continued development of roginolisib, with activation of trial sites for the phase 2 OCULE-01 study already underway. This next phase will investigate roginolisib versus investigator’s choice in second-line treatment of uveal melanoma.

iOnctura’s progress marks a significant advancement in the fight against neglected and hard-to-treat cancers, offering hope for patients with limited treatment options.