Cholangiocarcinoma: Targeted therapy Tibsovo reduces the risk of death by 63%!
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Cholangiocarcinoma: Targeted therapy Tibsovo reduces the risk of death by 63%!
This is the first and only targeted therapy for the treatment of patients with IDH1 mutant cholangiocarcinoma after treatment.
Recently, the US FDA announced the approval of the IDH1-targeted tablet Ivosidenib (Tibsovo) for the treatment of previously treated adult patients with locally advanced or metastatic cholangiocarcinoma with isocitrate dehydrogenase-1 (IDH1) mutations.
This is the first and only targeted therapy for the treatment of patients with IDH1 mutant cholangiocarcinoma after treatment.
▌Bile duct cancer is more dangerous than “cancer king”
Cholangiocarcinoma is a rare and aggressive cancer, and some countries is one of the countries with the highest incidence of cholangiocarcinoma in the world.
Cholangiocarcinoma mainly includes gallbladder cancer and intrahepatic cholangiocarcinoma, most of which are adenocarcinoma. Because the disease is difficult to detect in the early stage, most of it has reached the late stage when it is diagnosed.
At present, surgery is the most important treatment option for patients with cholangiocarcinoma. However, because advanced patients lose the opportunity for surgery, the first-line treatment is mainly standard chemotherapy.
However, the median survival time of many patients is less than one year, and the five-year survival rate is almost zero, which is even more dangerous than the “cancer king” pancreatic cancer. Even after some patients undergo surgical treatment, the recurrence rate of cancer is still very high, even more than 80%.
In recent years, targeted therapy and immunotherapy have brought new dawn to advanced cholangiocarcinoma. In April last year, the FGFR kinase inhibitor Pemigatinib was approved for the treatment of inoperable patients with FGFR2 fusion/rearrangement and inoperable cholangiocarcinoma, providing the first targeted treatment option for patients with first-line chemotherapy or recurrence after surgery.
However, at present, there is no approved therapy for IDH1 mutations in cholangiocarcinoma, and the available chemotherapy options in advanced patients are limited, and effective innovative therapies are urgently needed.
▌Ivosidenib targeting IDH1
Isocitrate dehydrogenase-1 (IDH1) mutation occurs in approximately 13% of cholangiocarcinoma patients, and is another key target gene after FGFR2.
IDH1 is an important metabolic enzyme, mainly present in peroxisomes and cytoplasm, helping to break down nutrients and produce energy. IDH1 mutations are common in a variety of blood cancers and solid tumors such as leukemia, lymphoma, cholangiocarcinoma and colorectal cancer.
Previously, Ivosidenib was approved in the United States as a single-drug treatment for adult patients with relapsed or refractory acute myeloid leukemia (AML) with IDH1 mutations.
▌The risk of death is reduced by 63%, and the targeted therapy is effective!
This approval is supported by positive data from the Phase 3 ClarIDHy clinical study, which is the first randomized Phase 3 trial of previously treated patients with IDH1 mutant cholangiocarcinoma.
ClarIDHy is an ongoing randomized, double-blind, placebo-controlled study. The enrolled 187 patients were randomized to receive Ivosidenib (n=126) or placebo (n=61) at a 2:1 ratio. The primary endpoint is progression-free survival (PFS), and the secondary endpoints are overall survival (OS), objective response rate, safety and tolerability, etc.
The results show:
Compared with placebo, Ivosidenib reduced the risk of disease progression or death in patients with IDH1 mutant cholangiocarcinoma by 63%. The median PFS of the treatment group and the placebo group were 2.7 months VS 1.4 months, respectively; progression-free survival was achieved The primary endpoint of a significant improvement in the period.
Among the patients randomly assigned to Ivosidenib treatment, 32% and 22% had no disease progression or died at 6 months and 12 months, respectively, and 0 patients in the placebo group.
In addition, Ivosidenib also significantly improved the overall survival (OS) of patients. The median OS was 10.3 months in the treatment group and 7.5 months in the placebo group.
According to the trial protocol, patients randomly assigned to the placebo group can be transferred to the Ivosidenib group for treatment when the disease progresses. Therefore, 70.5% of patients in the placebo group were transferred to the treatment group, resulting in the difference in OS that did not reach the statistically significant standard.
Throughout the study, Ivosidenib was safe and well tolerated.
Patients with cholangiocarcinoma with IDH1 mutations, especially patients with advanced disease who have progressed after chemotherapy, have limited treatment options, and new solutions are urgently needed. The approval of the targeted drug Ivosidenib is expected to meet the treatment needs of this type of refractory cancer population.
(source:internet, reference only)
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