AGIOS PHARMACEUTICALS, INC.
CAMBRIDGE -
The study met its primary endpoint, demonstrating a statistically significant improvement in progression-free survival (PFS) in patients randomized to TIBSOVO compared with placebo patients. The safety profile observed in the study was consistent with previously published data. Data from this study were previously presented at the
'We began researching IDH inhibition as a potential therapeutic approach for solid tumors more than five years ago with the goal of innovating on behalf of patients, including those with advanced cholangiocarcinoma, who desperately need new treatment options,' said
ClarIDHy Phase 3 Trial
The ClarIDHy trial is a global, randomized Phase 3 trial in previously treated IDH1-mutant cholangiocarcinoma patients who have documented disease progression following one or two systemic therapies in the advanced setting. Patients were randomized 2:1 to receive either single-agent TIBSOVO 500 mg once daily or placebo with crossover to TIBSOVO permitted at the time of documented radiographic progression per RECIST 1.1. At the time of the primary analysis, a total of 185 patients were randomized, with 124 patients in the TIBSOVO arm and 61 patients in the placebo arm. Thirty-five patients randomized to placebo (57.4%) crossed over to open-label TIBSOVO upon radiographic disease progression and unblinding.
Results of the study were as follows
Median PFS for patients randomized to TIBSOVO was 2.7 months compared to 1.4 months with placebo (hazard ratio [HR]=0.37; 95% CI [0.25, 0.54], one-sided p
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