The FDA has recently approved a new diagnostic tool to help determine which IDH1-mutated cholangiocarcinoma patients may be a good fit for the novel IDH1 inhibitor called ivosidenib. The new diagnostic tool is called the Oncomine Dx Target Test. This test was created by Thermo Fisher Scientific.
The Approval
This approval was based on the NCT02989857 trial, a phase 3 investigation called ClarIDHy. The trial included 187 patients who had faced disease progression while taking a prior treatment. All patients were at minimum 18 years old, had an ECOG of 0 or 1, decent renal, hepatic, and hematologic function, and measurable disease. All patients in this trial had an IDH1 mutation.
All patients were randomized to be given either ivosidenib orally or placebo. Both of these were given at 500mg. Treatment went on until the disease progressed or there were unacceptable levels of toxicity. After facing disease progression, those in the placebo group were given the option to begin ivosidenib.
The Phase 3 trial demonstrated that ivosidenib, when compared to placebo, improved progression-free survival (although not it was not significant to overall survival) for those who were diagnosed with either locally advanced cholangiocarcinoma or metastatic cholangiocarcinoma. Further, ivosidenib was found to preserve patients’ physical functioning and improve their pain levels.
The AEs experienced by at least 15% of participants given the ivosidenib treatment were fatigue, abdominal pain, cough, diarrhea, anemia, rash, vomiting, low appetite, and nausea.
Oncomine Dx Target Test
The oncomine diagnostic test was found to provide robust results for the IDH1 gene. This test was approved back in 2017 for 4 different targeted therapies for non-small cell lung cancer.
It is able to detect 23 different genes in a single sample. This is incredibly valuable as it means limited tissue sample biopsies are needed. Further, the test can be completed in just 4 days, providing patients answers faster.
You can read more about this diagnostic test here.
