2021 Tumor New Drug Data Card - Ginetinib

Basic Information Xospata (Xospata) is an oral selective FLT3 kinase inhibitor developed by Astellas in collaboration with Kotobuki Pharmaceutical, the world's first FLT3 inhibitor approved for the treatment of recurring, refracticable AML carrying FLT3 mutations.
gin is a FLT3 and AXL dual inhibitor, effective for both FLT3-ITD and FLT3-D835 mutations, and inhibits AXL kinases associated with FLT3 inhibitor resistance.
Submitted a listing application in China in April 2020 for the treatment of relapsed/resuscable AML with FLT3 mutation, was eligible for NMPA priority review in July 2020, and was included in the third batch of clinically urgent overseas new drugs in November 2020, and was officially approved on January 30, 2021 under the accelerated channel.
Q2 Listing Acute myeloid leukemia (AML) is one of the most common types of leukemia in adults, characterized by abnormal growth and differentiation of myelin cells, which is more common in the elderly, with serious complications and high mortality.
epidemiologists estimate that the number of AML patients worldwide will grow at an annual rate of 2.51% to 90,264 by 2029.
AML is caused by the abnormal proliferation of primitive hematopoietic stem cells and progeny cells, with the lowest survival rate of all types of leukemia, with a five-year survival rate of only about 28%.
About 30% of patients with AML have FLT3 mutations, including 25% internal series repetition (ITD) and 7% to 10% tyrosine kinase domain (TKD) point mutations, and the disease-free and total survival of these patients is worse.
Gretinib has shown inhibitory activity against these two different mutations ITD and TKD, treating relapses and refractic AML with FLT3 mutations has significant clinical advantages, and has been awarded breakthrough therapy qualification by the FDA for the treatment of AML. Launched in Japan and the United States in 2018, it is the world's first FLT3 inhibitor approved for the treatment of recurring, refragrant AML carrying FLT3 mutations, and has since been approved in several countries including the European Union, Canada, South Korea, Brazil and Australia.
AML drugs for FLT3 mutations, and similar products include quezatini and mitolin.
has conducted a Clinical Phase III. study in 2017 and has not yet submitted a listing application;
Q3 Adaptive Gretinib has been approved in China for the treatment of adult patients with acute myeloid leukemia (AML) who have been detected with FMS-like tyrosine kinase 3 (FLT3) mutations using well-proven testing methods.
Q4 evidence-based data and core clinical in the second-line treatment of FLT3 mutation recurrence / resuscable AML critical phase III clinical trial (ADMIRAL), the Ginitinib group significantly extended the mesos (9.3 vs. 5.6 months) compared to the chemotherapy group, reducing the risk of death by 36% (HR 0.64).
In addition, the medium event-free lifes of the gini and chemotherapy groups were 2.8 months and 0.7 months (HR, 0.79), respectively; the percentage of patients with full or partial hematological recovery was 34.0% and 15.3%, respectively; and the percentage of patients with complete remission was 21.1% and 10.5%, respectively.
safety, the rate of adverse events and severe adverse events at level 3 or higher was lower in the Girgitinib group than in the chemotherapy group, and the most common level 3 or higher adverse events in the Ginitinib group were a decrease in febrile nexual granulocytes (45.9 per cent), anemia (40.7 per cent) and a reduction in plateplates (22.8 per cent).
's path to research and development has not been easy.
In the clinical Phase III.PHASE TRIAL (LACEWING) of patients newly diagnosed with first-line therapy who did not meet the FLT3 mutation-positive AML of intensive induction chemotherapy, the interim analysis showed that the combination of Gretinib and aza cytosine did not reach the main endpoint of OS.
on December 21, 2020, Astellas announced that it had stopped registering for the trial.
currently, Ginotinib is also being developed to treat AML at different stages of the disease, including maintenance therapy after carrying allo-SCT in patients with FLT3 mutation AML, newly diagnosed/suitable for intensive chemotherapy in AML patients.
Xospata Core Clinical Layout Source: NextClinTrial Database, which retains only key clinical trials for drug registration or change of guidelines; CSCO Guidelines for the Diagnosis and Treatment of Malignant Blood Diseases (2020, AML section) Relapse Recurring Difficult AML Treatment Options (based on recurrence time and age stratization) Relapse Recurring Incurable Leukemia is still poor in prognosis using current treatment options.
When choosing a chemotherapy treatment option, you should consider the patient's cytogenetics, immunotype, recurrence time, individual factors of the patient (e.g. age, physical condition, compulsive disorder, early treatment plan) and the patient's willingness to treat.
recommends that patients with relapse improve the molecular expression spectrum (including FLT3, IDHI/2 mutations) to help patients choose the right clinical trial.