Servier Korea hosts symposium on the clinical significance of Tibsovo at KSMO 2024

Servier Korea said it held a luncheon symposium during the Korean Society of Medical Oncology (KSMO) 2024 Conference on Thursday.

The symposium focused on the clinical importance of Tibsovo (ingredient: ivosidenib).

Tibsovo received approval from the Ministry of Food and Drug Safety on May 22, for use as a monotherapy in adults with locally advanced or metastatic cholangiocarcinoma with IDH1 mutations who have undergone prior treatment.

It is also approved for combination therapy with azacitidine for newly diagnosed IDH1-mutated acute myeloid leukemia (AML) patients aged 75 years or older, or those with comorbidities that make them unsuitable for intensive induction chemotherapy.

The drug was officially launched in Korea on Sept. 1, and is currently the only targeted therapy for cholangiocarcinoma recommended as a Category 1 treatment by the NCCN guidelines.

Under the theme "Redefining the Management of IDH1 Mutation Patients with the Arrival of Ivosidenib," the symposium featured Professor Lee Myung-Ah of the Department of Medical Oncology at Seoul St. Mary’s Hospital as the chair, with Professor Kim Kyu-pyo of the Department of Oncology at Asan Medical Center presenting the latest clinical data and insights on Tibsovo.

The presentation highlighted the drug’s mechanism of action and its effectiveness in treating IDH1-positive cholangiocarcinoma and AML.

According to Kim, Tibsovo demonstrated notable efficacy in patients with cholangiocarcinoma and AML. The drug's ability to prolong progression-free survival (PFS), event-free survival (EFS), overall survival (OS), and ensure safety were emphasized during the session.

“The phase 3 clinical trial (ClarIDHy) for cholangiocarcinoma marked a milestone as the first randomized trial to prove clinical benefits in IDH1-mutated cholangiocarcinoma patients,” Kim said.

Tibsovo reduced the risk of disease progression by 63 percent compared to placebo, with a median PFS of 2.7 months (versus 1.4 months for the placebo group).

Also, 32 percent of patients achieved a 6-month PFS, and 22 percent reached a 12-month PFS. The median OS in the Tibsovo group was 10.3 months, more than double the placebo group’s 5.1 months, when adjusted with the rank-preserving structural failure time model.

Professor Lee also commented on the significance of the results, stating, "As an oral targeted therapy that has demonstrated both safety and tolerability, Tibsovo offers a promising treatment option for cholangiocarcinoma patients, who face a challenging treatment journey."

She also stressed the importance of molecular genetic diagnosis in identifying the right patients for this treatment.

In AML, Tibsovo has shown similarly positive outcomes.

The phase 3 AGILE trial demonstrated that combining Tibsovo with azacitidine improved EFS to 22.9 months compared to 4.1 months in the placebo group, alongside a significant improvement in OS.

The median OS for patients receiving Tibsovo was 24.0 months, compared to 7.9 months for the placebo group. Long-term follow-up further revealed that the median OS with Tibsovo and azacitidine reached 29.3 months, over 3.7 times longer than the placebo group, with a 58 percent reduction in the risk of death.

"Tibsovo has proven its efficacy and safety in treating both IDH1-mutated cholangiocarcinoma and AML,” Kim said. “Considering that both trials allowed for crossover treatment, the significant improvement in survival outcomes is particularly noteworthy.”

With limited treatment options available for these conditions, Tibsovo presents a new opportunity to enhance treatment outcomes and quality of life for patients in Korea, Kim added.

Servier Korea CEO Mathieu Mendis also said, "The approval and launch of Tibsovo in Korea marks a significant advancement for patients with IDH1-mutated cholangiocarcinoma and AML.”

Servier Korea is making concerted efforts to improve the accessibility of Tibsovo, including securing insurance coverage, to ensure that patients in need can benefit from this important therapy, Mendis added.