Servier Korea Launches Game-Changing Drug Tibsovo For Rare Cancers

Servier Korea introduced Tibsovo Tablet (ivosidenib) to the Korean market. This medication, which targets mutations in the IDH1 (isocitrate dehydrogenase 1) gene, received approval from the Ministry of Food and Drug Safety (MFDS) in May, just four months prior to its launch. Tibsovo is approved for use as a monotherapy in adults with locally advanced or metastatic cholangiocarcinoma harboring the IDH1 mutation. It is also indicated in combination with azacitidine for newly diagnosed acute myeloid leukemia (AML) in patients aged 75 and above, or those with health conditions that preclude intensive induction chemotherapy.

Cholangiocarcinoma, a cancer known for its grim prognosis, has a five-year relative survival rate of just 28.9 percent. This is particularly dire for intrahepatic cholangiocarcinoma, where 65 percent of cases are deemed inoperable at the time of diagnosis. Tibsovo stands out as the only targeted therapy recommended as a second-line treatment for cholangiocarcinoma by the U.S. National Comprehensive Cancer Network (NCCN), earning a Category 1 classification, the network's highest endorsement. In the ClarlDHy phase 3 trial, Tibsovo showed a 63 percent reduction in the risk of disease progression compared to placebo, with a median progression-free survival (PFS) of 2.7 months versus 1.4 months for the placebo group. The median overall survival (OS) in the Tibsovo group was 10.3 months, significantly longer than the 5.1 months observed in the placebo group (HR=0.49, p<0.0001).

Similarly, in the phase 3 AGILE study involving AML patients, Tibsovo, when combined with azacitidine, significantly improved event-free survival (EFS) (HR=0.33; 95 percent CI, 0.16-0.69; p=0.002) and overall survival (OS) (HR=0.44; 95 percent CI, 0.27-0.73; p=0.001). The median OS in the Tibsovo arm reached 24.0 months, compared to just 7.9 months in the placebo arm. Long-term follow-up revealed that the median OS with the Tibsovo combination was 29.3 months (HR=0.42; 95 percent CI, 0.27-0.65; p=0.0001), over 3.7 times longer than the OS with the placebo combination. The Ministry of Food and Drug Safety (MFDS), which has approved Tibsovo, anticipates that the drug will offer a crucial new treatment option for patients with IDH1 mutation-positive acute myeloid leukemia or cholangiocarcinoma.

Kim Kyun-ji, head of the Medical Department at Servier Korea. , remarked “Korea's cholangiocarcinoma mortality rate is among the highest in the world at 11.6 per 100,000 people, and the five-year survival rate for metastatic cholangiocarcinoma is only 3.2 percent. The launch of Tibsovo is very significant in this context.”

Matthieu Mendil, CEO Of Servier Korea CEO said in a statement, “We are excited to bring new treatment opportunities to patients with cholangiocarcinoma and acute myeloid leukemia in Korea with Tibsovo.”

Mendil emphasized Servier's dedication to developing therapies that address patient needs, highlighting this launch as a significant milestone in the treatment of rare cancers. Established in 1990, Servier Korea operates as the Korean branch of the French multinational pharmaceutical company, Servier. Managed by the Servier non-profit foundation, the company is dedicated to research and development across various therapeutic areas, including oncology, cardiovascular metabolism, neurology, and autoimmune diseases.