Glasdegib in combination with temozolomide and radiotherapy in adult patients with newly diagnosed glioblastoma: the phase Ib/II GEINO 1602 trial.

ABSTRACT: The hedgehog pathway is implicated in resistance to anticancer therapies in glioblastoma (GB). GEINO1602 (NCT03466450) phase Ib/II study evaluated the safety and efficacy of glasdegib and the Stupp scheme in newly diagnosed GB. Patients received glasdegib with radiotherapy plus concomitant and 6 cycles of adjuvant temozolomide followed by glasdegib monotherapy. The recommended phase 2 dose was 75 mg/day of glasdegib. The primary endpoint was the 15-months overall survival (OS), with a futility threshold of 60% to consider the trial positive; accrual required 70 evaluable patients. 79 patients were enrolled. The 15 m OS rate was 52.1% (95% CI: 41.7-65.2). At 2 years, 29.2% of the patients were still alive. The median progression-free survival (PFS) was 7.1 months (95% CI: 6.2-8.6). Glasdegi

SUBMITTER: Vaz-Salgado MA 

PROVIDER: S-EPMC12769667 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature