Rigel Pharmaceuticals collaborating with Connect network in Phase 2 glioma trial

Rigel Pharmaceuticals announced a collaboration with CONNECT, an international collaborative network of pediatric cancer centers, to conduct a Phase 2 clinical trial to evaluate Rezlidhia – olutasidenib – in combination with temozolomide as maintenance therapy in newly diagnosed pediatric and young adult patients with high-grade glioma harboring an isocitrate dehydrogenase-1 mutation. Under the collaboration, CONNECT will include olutasidenib in CONNECT’s TarGeT-D, a molecularly guided Phase 2 umbrella clinical trial for HGG. The Rigel-sponsored arm will study post-radiotherapy administration of olutasidenib in combination with temozolomide followed by olutasidenib monotherapy as maintenance treatment in newly diagnosed pediatric and young adult patients with IDH1 mutation positive HGG, including diffuse intrinsic pontine glioma, an aggressive brain tumor with limited treatment options. Rigel will provide funding up to $3M and study material over the four-year collaboration. The primary objective of the olutasidenib arm of the trial is to estimate progression-free survival. The study is estimated to begin enrolling patients in the first half of 2024 and will fulfill Rigel’s post-marketing pediatric study requirement related to the FDA approval of Rezlidhia in relapsed or refractory AML.