CCA, cholangiocarcinoma; ECOG PS, Eastern Cooperative Oncology Group Performance Status; IDH1, isocitrate dehydrogenase-1; mIDH1, mutated IDH1; NGS, next-generation sequencing; QD, once a day; RECIST, Response Evaluation Criteria in Solid Tumors.
References: 1. Tibsovo. Package insert. Servier Pharmaceuticals LLC; 2022. 2. Data on file. Servier Pharmaceuticals LLC. 3. Zhu AX, Macarulla T, Javle MM, et al. Final results from the ClarIDHy Phase III study of ivosidenib versus placebo in patients with previously treated cholangiocarcinoma and an isocitrate dehydrogenase 1 (IDH1) mutation. EMJ Oncol. 2021;9(suppl 2):2-5. doi:10.1200/JCO.2021.39.3_suppl.266
| TIBSOVO (n=124) |
Placebo (n=61) |
||
| Demographics | |||
|---|---|---|---|
| Median age, years (min, max) | 61 (33,80) | 63 (40,83) | |
| Sex | |||
| Male | 36% | 40% | |
| Female | 65% | 61% | |
| Race | |||
| White | 57% | 57% | |
| Asian | 12% | 13% | |
| Black | 0.8% | 1.6% | |
| Native Hawaiian/Other Pacific Islander | 0.8% | 0% | |
| American Indian or Alaska Native | 0.8% | 0 | |
| Disease characteristics | |||
| Prior lines of therapy | |||
| 1 prior line of therapy | 53% | 54% | |
| 2 prior lines of therapy | 47% | 46% | |
| ECOG PS | |||
| 0 | 40% | 31% | |
| 1 | 60% | 67% | |
| IDH1 mutation | |||
| R132C | 68% | 74% | |
| R132L | 17% | 12% | |
| R132G | 14% | 10% | |
| R132H | 0% | 3.3% | |
| R132S | 1.6% | 1.6% | |
| Cholangiocarcinoma type at initial diagnosis | |||
| Intrahepatic | 90% | 95% | |
| Metastatic disease | 93% | 92% | |
ECOG PS: Eastern Cooperative Oncology Group Performance Status.
References: 1. Tibsovo. Package insert. Servier Pharmaceuticals LLC; 2023. 2. Data on file. Servier Pharmaceuticals LLC.
TIBSOVO is indicated for patients with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma who have been previously treated.
QTc Interval Prolongation: Patients treated with TIBSOVO can develop QT (QTc) prolongation and ventricular arrhythmias. Concomitant use of TIBSOVO with drugs known to prolong the QTc interval (eg, anti-arrhythmic medicines, fluoroquinolones, triazole anti-fungals, 5-HT3 receptor antagonists) and CYP3A4 inhibitors may increase the risk of QTc interval prolongation. Conduct monitoring of electrocardiograms (ECGs) and electrolytes. In patients with congenital long QTc syndrome, congestive heart failure, or electrolyte abnormalities, or in those who are taking medications known to prolong the QTc interval, more frequent monitoring may be necessary. Interrupt TIBSOVO if QTc increases to greater than 480 msec and less than 500 msec. Interrupt and reduce TIBSOVO if QTc increases to greater than 500 msec. Permanently discontinue TIBSOVO in patients who develop QTc interval prolongation with signs or symptoms of life-threatening arrhythmia.
