Will 'Tibsovo' be listed for reimbursement in H2?

Has passed the Cancer Disease Review Committee at the second attempt

Will there be a new treatment option for cholangiocarcinoma with limited medicines?

Under discussion for the DREC review date…AML indication will also be submitted for review

Product photo of Tibsovo

As 'Tibsovo' seeks insurance reimbursement for cholangiocarcinoma, a disease with limited treatment options, attention is being paid to whether it will achieve results in the second half of this year.

 

According to industry sources, Servier's Tibsovo (ivosidenib) is currently under discussion for the review schedule for the Drug Reimbursement Evaluation Committee (DREC).

 

Tibsovo is a targeted cancer drug for cholangiocarcinoma and acute myeloid leukemia (AML), and it has passed the Health Insurance Review & Assessment Service (HIRA)'s Cancer Disease Review Committee.

 

This is the second attempt for Tibsovo to be listed for cholangiocarcinoma indication.

 

Tibsovo's AML indication passed the Cancer Disease Review Committee in October of last year.

 

Tibsovo's indication is specified as follows: If a patient tests positive for IDH1 mutation, Tibsovo can be used as a ▲Monotherapy in patients with locally advanced or metastatic AML who have had prior therapy ▲Combination therapy with 'azacitidine' in adult patients over 75 years with accompanying disease that cannot be treated with chemotherapy.

 

Cholangiocarcinoma is a cancer with a poor prognosis.

 

The five-year relative survival rate is only 28.9%.

 

65% of the patients with cholangiocarcinoma of the liver are found be non-operable when diagnosed.

 

Tibsovo is the only targeted drug recommended as a Category 1, the highest grade, by the National Comprehensive Cancer Network (NCCN) for a second-line treatment for cholangiocarcinoma.

 

According to ClarlDHy Phase 3 clinical trial, Tibsovo reduced the disease progression by 63% compared to a placebo and had a median progression-free survival (PFS) of 2.7 months (placebo 1.4 months).

 

Also, patients treated with Tibsovo had a median overall survival (OS) of 10.3 months, which was longer over twice than 5.1 months of those treated with a placebo.

 

Meanwhile, in the AGILE Phase 3 trial involving patients with AML, Tibsovo was demonstrated to improve event-free survival (EFS) when combined with azacitidine, and the overall survival (OS) was significantly improved.

 

The patients treated with Tibsovo had a median OS of 24.0 months (placebo 7.9 months).

 

In a long-term follow-up study, the median OS of Tibsovo combination therapy was 29.3 months, over 3.7-fold longer than that of placebo combination therapy.

 

Professor Kyu-Pyo Kim of Asan Medical Center's Department of Oncology said, "Tibsovo is indicated to treat IDH1 mutation-positive cholangiocarcinoma and AML.

 

The efficacy and safety of this drug were confirmed in clinical trials.

 

Notably, considering that both studies have been designed to allow switching regimen, a significant improvement in OS indicates a very meaningful outcome." Professor Kim added, "Since a new targeted drug that is effective for cholangiocarcinoma and AML, diseases with limited treatment options, has emerged, it is expected to contribute to improving treatment outcomes and quality of life in patients with cholangiocarcinoma and AML in Korea."