Agios Pharmaceuticals Inc. (NASDAQ:AGIO) has announced final overall survival analysis results from its Phase 3 ClarlDHy TIBSOVO® trial in cholangiocarcinoma patients have received prior treatment and having the isocitrate dehydrogenase 1 (IDH1) mutation.
TIBSOVO® treatment showed improved overall survival in patients
Although the company observed a consistent trend in improved overall survival in the patients that received TIBSOVO® relative to those in the placebo group, the result was not significant statistically. The overall survival endpoint was impacted by crossover as a large percentage of the patients, around 70% in the placebo group, crossed over for TIBSOVO® treatment after radiographic disease progression. Alos more analyses carried to consider crossover further supported evidence that TIBSOVO® could improve overall survival.
The company had previously announced that the trial had met its primary endpoint, which was progression-free survival. Results indicated statistically significant improvement in progression-free survival in patients who received 500 mg of TIBSOVO® daily than the placebo group with crossover to TIBSOVO®. Overall survival in the ClarlDHy trial was a secondary endpoint, and there was a favorable safety profile shown in the study, which was consistent with previously released data.
Agios to submit supplemental New Drug Application for TIBSOVO®
Chris Bowden, the company’s chief medical officer, stated that advanced cholangiocarcinoma is an aggressive disease with rapid progression that has a grim diagnosis for patients. He said that the data from the company’s ClarlDHy Third phase study showed that TIBSOVO® treatment has the potential of extending the period to progression with clinically meaningful effect on the life expectancy of IDH1-mutant cholangiocarcinoma patients. Bowden added that they will continue working closely with regulators in advancing this potential novel oral, targeted therapy alternative for patients.
Agios is planning for a supplemental new drug application submission for TIBSOVO® in IDH1-mutant cholangiocarcinoma patients with prior treatment in Q1 2021 and will be working closely with regulators on this pathway. The company will submit a full analysis of ClarlDHy overall survival results at a presentation in a future medical meeting. TIBSOVO® is yet to be approved as a treatment for IDH1-mutant cholangiocarcinoma.