The effect of ivonib (ivitinib) in the treatment of cholangiocarcinoma

Ivosidenib is an isocitrate dehydrogenase-1 inhibitor that works by reducing the abnormal production of the oncometabolite 2-hydroxyglutarate (2-HG), which leads to malignant cell differentiation. Avosidenib may be used to treat cholangiocarcinoma that has progressed after treatment with other drugs or has spread to other parts of the body (metastatic).

USThe FDA approval is based on the ClarIDHy study, a randomized phase 3 trial in previously treated IDH1-mutant cholangiocarcinoma. Results from the ClarIDHy study by an independent review committee showed a statistically significant improvement in the primary endpoint of progression-free survival (PFS). The median PFS was 2.7 months for ivonib and 1.4 months for placebo. Of the patients randomized to ivosidenib, 32% and 22% were free of progression or dead at 6 months and 12 months, respectively, compared with none in the placebo group. The study protocol clearly stated that patients randomized to receive placebo could switch to ivosidenib if their disease progressed, and a high proportion of patients in the placebo group (70.5%) switched to ivosidenib. The study also showed that the key secondary endpoint of overall survival (OS) favored patients randomized to receive ivosidenib compared with those randomized to placebo; however, statistical significance was not reached. OS results are based on the final analysis of OS (based on 150 events occurring after 16 months in the final analysis of PFS. The median OS for ivonib was 10.3 months; for placebo it was 7.5 months, without adjustment for crossover.

Avosidenib has demonstrated good safety and tolerability in the treatment of cholangiocarcinoma. In clinical trials, ivonib had fewer side effects and patients tolerated the treatment process better. At the same time, the recommended dosage of ivonib is 500 mg orally per day, which can be adjusted according to the patient's physical condition and drug tolerance.

In summary, ivonib has achieved significant results in the treatment of cholangiocarcinoma, providing a new treatment option for patients with cholangiocarcinoma carryingIDH1 gene mutations. With the continuous deepening and expansion of clinical research, it is believed that ivonib will bring new options to more patients with cholangiocarcinoma in the future.