FDA Approves Tibsovo for Adjuvant Treatment of IDH1-Mutated UC
The FDA approved ivosidenib (Tibsovo, Servier) for adults with previously treated, locally advanced or metastatic cholangiocarcinoma with an isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.
The agency also approved the Oncomine Dx Target Test (Life Technologies) as a companion diagnostic device to aid in selecting patients with cholangiocarcinoma for treatment with ivosidenib.
"Patients living with IDH1-mutated cholangiocarcinoma, especially those whose disease progresses following chemotherapy, are in urgent need of new treatment options," said Rachna T. Shroff, MD, the chief of GI medical oncology at the University of Arizona Cancer Center, in Tucson. “In addition to an acceptable safety profile, [ivosidenib] demonstrated an impressive, significant benefit in progression-free survival [PFS], underscoring its importance as a new option for patients battling this aggressive cancer."
Ivosidenib was investigated in the multicenter, double-blind, placebo-controlled ClarIDHy trial (also called Study AG120-C-005) (ClinicalTrials.gov Identifier: NCT02989857). In the study, investigators evaluated 185 adults with locally advanced or metastatic cholangiocarcinoma with an IDH1 mutation. Enrolled patients had disease that progressed after at least one but not more than two prior regimens, including at least one gemcitabine- or 5-fluorouracil-containing regimen. Patients were randomly assigned in a 2:1 fashion to receive 500 mg of ivosidenib once daily or a matched placebo until disease progression or unacceptable toxicity. The study protocol specified that patients randomized to placebo could cross over to ivosidenib at the time of disease progression, and a high proportion of patients in the placebo arm (70.5%) crossed over.
The primary efficacy end point was PFS, as determined by an independent review committee according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. Ivosidenib was associated with a significant improvement in PFS (hazard ratio, 0.37; 95% CI, 0.25-0.54; P<0.0001).
A key secondary end point, overall survival (OS), favored patients randomized to ivosidenib compared with those randomized to placebo, but the difference was not significant. The OS results were based on the final analysis of OS (based on 150 events that occurred 16 months after the final analysis of PFS). The median OS was 10.3 months (95% CI, 7.8-12.4 months) for ivosidenib and 7.5 months (4.8-11.1 months) for placebo without adjusting for crossover (HR, 0.79; 95% CI, 0.56-1.12; P=0.093).
The most common adverse reactions to ivosidenib (≥15% of patients) were fatigue, nausea, abdominal pain, diarrhea, cough, decreased appetite, ascites, vomiting, anemia and rash.
For more information, see the complete prescribing information for ivosidenib.
Servier is introducing ServierONE Patient Support Services, a program that offers one-on-one support for patients who are prescribed ivosidenib or other Servier products. Eligible patients will have access to financial assistance, emotional support and other resources. More information can be found at www.servierone.com.
—PPN Staff
Based on press releases from the FDA and Servier.
AUGUST 30, 2021
https://www.pharmacypracticenews.com/
