Agios Presents Final Data from Phase 3 ClarIDHy Study of TIBSOVO (ivosidenib tablets) in Patients with Previously Treated IDH1-Mutant Cholangiocarcinoma

CAMBRIDGE, Mass., Jan. 17, 2021 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat cancer and genetically defined diseases, today reported a full analysis of the final data, including mature overall survival (OS) results, from its global Phase 3 ClarIDHy trial of TIBSOVOA (ivosidenib tablets) in patients with previously treated isocitrate dehydrogenase 1 (IDH1) mutated cholangiocarcinoma. Data from the study were featured in an oral presentation at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO-GI), which is being held virtually January 15-17, 2021.
The final analysis showed an improvement in the secondary endpoint of OS favoring patients randomized to TIBSOVOA compared to those randomized to placebo; however, statistical significance was not reached. The median OS for patients randomized to TIBSOVOA was 10.3 months compared to 7.5 months for patients randomized to placebo (hazard ratio [HR]=0.79; 95% CI [0.56a??1.12], 1-sided p=0.093). The protocol specified that patients randomized to placebo could cross over to TIBSOVOA at the time of disease progression, and a high proportion of patients in the placebo arm (70.5%) crossed over to TIBSOVOA. The results of a pre-specified analysis to adjust for crossover, based on the rank-preserving structural failure time (RPSFT) model, showed a median OS for patients in the placebo arm of 5.1 months (HR=0.49, 95% CI 0.34a??0.70, 1-sided p<0.0001). 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 (PFS) by independent radiology review.a??The progression-free survival and overall survival data from the ClarIDHy Phase 3 study, coupled with a tolerable safety profile and supportive patient-reported quality-of-life data, demonstrate that TIBSOVOA has the potential to be a clinically meaningful treatment option for patients with previously treated IDH1-mutant cholangiocarcinoma, an aggressive cancer with limited effective treatment options,a?? said Andrew Zhu, M.D., Ph.D., director emeritus of liver cancer research at Massachusetts General Hospital, director of Jiahui International Cancer Center and professor of medicine at Harvard Medical School. a??Treatment with TIBSOVOA resulted in a consistent trend in improved overall survival, despite the high rate of crossover from the placebo arm, and this improvement was further supported by the pre-specified statistical analysis to adjust for the crossover effect. I look forward to the potential of having a new treatment option for my patients with this devastating disease.a??a??We are extremely pleased with the results of the ClarIDHy Phase 3 study, the first and only randomized Phase 3 trial for IDH1-mutant advanced cholangiocarcinoma, and believe TIBSOVOA has demonstrated compelling results for patients facing a grim prognosis who currently have few treatment options,a?? said Chris Bowden, M.D., chief medical officer at Agios. a??We will collaborate closely with regulators to advance this potential new oral, non-cytotoxic, targeted treatment option, and we look forward to filing for U.S. approval later this quarter.a??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 TIBSOVOA 500 mg once daily or placebo with crossover to TIBSOVOA permitted at the time of documented radiographic progression per RECIST 1.1. The primary endpoint of the ClarIDHy trial is progression-free survival (PFS) as evaluated by independent radiology review. Secondary endpoints include investigator-evaluated PFS, safety and tolerability, overall response rate, OS, duration of response, pharmacokinetics, pharmacodynamics and quality of life assessments.
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