2021-01-17 15:32:00 AGIO Agios Pharmaceuticals
01/17/21 01/1715:32 01/17/2115:32 | Agios Pharmaceuticals presents final data from Phase 3 ClarIDHy study of TIBSOVOAgios Pharmaceuticals reported a full analysis of the final data, including mature overall survival results, from its global Phase 3 ClarIDHy trial of TIBSOVO in patients with previously treated isocitrate dehydrogenase 1 mutated cholangiocarcinoma. Data from the study were featured in an oral presentation at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium. The final analysis showed an improvement in the secondary endpoint of OS favoring patients randomized to TIBSOVO compared to those randomized to placebo; however, statistical significance was not reached. The median OS for patients randomized to TIBSOVO was 10.3 months compared to 7.5 months for patients randomized to placebo. The protocol specified that patients randomized to placebo could cross over to TIBSOVO at the time of disease progression, and a high proportion of patients in the placebo arm crossed over to TIBSOVO. The results of a pre-specified analysis to adjust for crossover, based on the rank-preserving structural failure time model, showed a median OS for patients in the placebo arm of 5.1 months. The safety profile observed in the study was consistent with previously published data. As previously announced, the study demonstrated a statistically significant improvement in the primary endpoint of progression-free survival by independent radiology review. |
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