Andrew X. Zhu, MD, PhD, discusses the final results from the phase 3 ClarIDHy study of ivosidenib versus placebo as treatment of patients with previously treated cholangiocarcinoma and an IDH1 mutation.
Andrew X. Zhu, MD, PhD, professor of medicine at the Harvard Medical School and director of Liver Cancer Research at the Massachusetts General Hospital Cancer Center, discusses the final results from the phase 3 ClarIDHy study of ivosidenib (Tibsovo) versus placebo as treatment of patients with previously treated cholangiocarcinoma and an IDH1 mutation.
Overall, the findings demonstrated a numeric improvement in overall survival (OS) with ivosidenib compared with placebo. In the intent-to-treat population, the median OS was 10.3 months with ivosidenib versus 7.5 months with placebo. Interestingly, Zhu says 70% of patients in the placebo arm crossed over, but despite the high crossover rate, there was still a trend for median OS improvement.
In a respecified analysis, the adjusted median OS still demonstrated significant improvement with ivosidenib, says Zhu. In addition, when looking at the safety of this therapy in patients with cholangiocarcinoma, the agent had a very favorable safety profile. According to Zhu, these findings are encouraging.