CStone's Avonib was unveiled at the ESMO conference, the data on the treatment of IDH1 mutation R/R AML is eye-catching, and the domestic commercialization is imminent

Recent popular reports from Yimaike ★ CStone Pharmaceuticals announced new progress in targeted therapy for non-small cell lung cancer at the 2021 World Lung Cancer Conference (WCLC), bringing hope to more Chinese patients for treatment | Yimai Meng broke the news ★Various PD-(L )1 Appeared at the World Lung Cancer Conference, CStone Pharmaceuticals has eye-catching data on suglizumab, which can cover both stage III and stage IV NSCLC patients | Yimai Meng broke the news September 26, 2021 / Yimai Ke News eMedClub News/--2021 The European Society of Medical Oncology (ESMO) Annual Conference-Virtual Conference will be held on September 16-21, 2021.
The conference is hosted by ESMO
.

The ESMO Conference is the most prestigious and influential oncology conference in Europe.
More than 30,000 professionals attend the conference every year.
Clinicians, researchers, patient advocates, journalists and pharmaceutical professionals from all over the world gather together.
, To share and understand the latest developments in oncology in order to transform science into better treatments for cancer patients
.

 CStone's first drug of its kind, Avonib, recently unveiled at the 2021 European Society of Medical Oncology (ESMO) annual meeting, which aims to bridge the Chinese registration of IDH1 mutation relapsed or refractory acute myeloid leukemia (R/R AML) Study CS3010-101 presented clinical data at the conference in the form of an oral report
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 Acute myeloid leukemia (AML) is the most common acute leukemia in adults with a poor prognosis.
There are about 20,000 new cases in the United States each year, and China is expected to have more than 30,000 new cases each year
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Studies have shown that about 6%-10% of AML patients have IDH1 mutations.
The mutated IDH1 enzyme causes abnormal accumulation of metabolites, which blocks the differentiation of normal hematopoietic stem cells and promotes the onset of acute leukemia
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However, the existing treatment options for AML patients with IDH1 mutations are limited, the 5-year survival rate is low, and the patient's quality of life is poor
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 Ivosidenib is a potent oral inhibitor targeting IDH1, which can reduce the carcinogenic metabolite 2HG in the body, thereby inducing histone demethylation and achieving the effect of inhibiting tumor development
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Avnib was approved by the U.
S.
FDA in 2018 for the treatment of adult patients with IDH1 mutations in R/R AML
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The drug is the world's first therapy approved by the US FDA for IDH1 mutant R/R AML, and it will be approved soon in China.
It is expected to fill the gap in targeted therapy in this field and bring new hope to patients
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 R/R AML: The clinical efficacy is significant.
The CS3010-101 study in many patients with complete remission is a phase I, multi-center, single-arm study of adult R/R AML patients with susceptible IDH1 mutations in China.
As a bridging study of the global key research AG120-C-001
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The National Medical Products Administration (NMPA) of China has accepted the new drug marketing application of Avnib for R/R AML adult patients susceptible to IDH1 mutations and included it in priority review
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In July 2021, Afnib's registration bridging study CS3010-101 in China reached the expected end point.
Among Chinese R/R AML patients with susceptible IDH1 mutations, Afnib showed clear efficacy and controllable Safety, and basically consistent with the efficacy and safety data in the global research population
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 ➤ Effectiveness: Among the 30 evaluable patients, the primary efficacy endpoint complete remission and complete remission with partial hematological recovery (CR+CRh) rate was 36.
7% (11/30, all 11 patients achieved CR)
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The median time to CR+CRh was 3.
68 months, and the continuous remission rate of CR+CRh at 12 months was 90.
9%.
Two patients underwent hematopoietic stem cell transplantation (HSCT) after reaching CR or CRH remission.
Median no event The survival time (EFS) was 5.
52 months, and the median overall survival (OS) was 9.
10 months.
➤ Safety: The rate of adverse events (TEAE) above grade 3 was 86.
7%, and the rate of TEAEs leading to permanent discontinuation was 10% has good safety and no new safety signals have been found.
Adverse events of particular concern can be effectively monitored and controlled through program guidance and clinical routine management.
In general, Avonib is used in the treatment of adults who are susceptible to IDH1 mutations.
R/R AML has shown excellent clinical efficacy in Chinese patients, and it is well tolerated and its safety is controllable
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And the pharmacokinetic characteristics, safety and efficacy data observed in this bridging study are comparable with the data observed in the key study AG120-C-001 conducted in the United States and France
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Significant potential for expansion of indications ➤ As the first-line treatment for newly diagnosed AML patients, in addition to adult R/R AML with IDH1 mutations, Afnib has conducted research on more indications
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The AGILE study is a global phase III clinical study conducted in previously untreated patients with IDH1 mutant AML, which aims to evaluate the efficacy of Afnibu combined with azacitidine as the first-line treatment of IDH1 mutant AML
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In August 2021, the AGILE study successfully reached the primary end point of event-free survival (EFS).
Compared with azacitidine combined with placebo, ivosidenib combined with azacitidine treatment achieved results in EFS A statistically significant improvement
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In addition, the trial reached all its key secondary endpoints, including complete remission (CR) rate, overall survival (OS), CR and complete remission (CRh) rate with partial hematological recovery, and objective remission rate (ORR)
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The safety of Afnibu combined with azacitidine is consistent with previously published data
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The results of this study are of great significance to untreated IDH1 mutant AML patients.
In addition to the treatment of IDH1 mutant R/R AML adult patients, ivosidenib (ivosidenib) is also supported as a first-line treatment for AML
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  ➤ As a treatment for cholangiocarcinoma, the data of Avonib in patients with IDH1 mutant cholangiocarcinoma also achieved excellent efficacy and safety
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The latest results of the global phase III study ClarIDHy showed that in patients with advanced IDH1 mutant cholangiocarcinoma who had previously received treatment, the primary endpoint of progression-free survival (PFS) was significantly improved
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The median PFS of the avonib group and the placebo group were 2.
7 months and 1.
4 months, respectively
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The PFS rate in the Avonib group was 32% at 6 months, and the PFS rate at 12 months was 22%.
Compared with the placebo group, the risk of disease progression or death was reduced by 63%
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 In August 2021, in view of the positive data from the ClarIDHy study, Avonib was approved by the US FDA for a new indication for use in previously treated adult patients with locally advanced or metastatic cholangiocarcinoma with IDH1 mutations
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Avnib is the first and only drug approved by the US FDA for targeted therapy of patients with IDH1 mutant cholangiocarcinoma
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  ➤ As a treatment for glioma, IDH1 gene mutations are not only found in AML and cholangiocarcinoma, but also in a variety of tumors including glioma
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In a basket trial conducted in patients with advanced solid tumors, Avnib performed well in patients with IDH1 mutant advanced glioma, showing good safety characteristics, long-term disease control, and significantly reduced tumor growth
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The relevant results were published in the Journal of Clinical Oncology in June 2020
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 Domestic commercialization is approaching in August 2021, Afnib's New Drug Application (NDA) was accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China for the treatment of adult R/R AML with susceptible IDH1 mutations
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It is expected to be approved by the NDA at the end of 2021 or the first quarter of 2022
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 As the first IDH1 inhibitor of its kind in the world, Afnib was included in the "Clinically Needed Overseas New Drug List (third batch)" by CDE in 2020, and was qualified for fast-track review and approval
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At the same time, Avnib has been selected for the 2020 edition of the "CSCO Guidelines for Diagnosis and Treatment of Malignant Hematological Diseases" with its clear clinical advantages
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In addition, in the "Guidelines for the Diagnosis and Treatment of Chinese Adult Acute Myeloid Leukemia (Non-acute Promyelocytic Leukemia)" published in 2021, IDH1 and C-kit D816V are all required genes for newly diagnosed AML patients
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Subsequently, Avnib was selected as the "Guidelines for the Diagnosis and Treatment of Relapsed and Refractory Acute Myeloid Leukemia (2021 Edition)" and was recommended for adult R/R AML patients with IDH1 susceptible mutations.
Afnib combined with demethylation drugs is also recommended
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It is worth noting that although Avonib has not yet been approved for commercialization in China, it has made a major breakthrough in the dimension of drug availability ahead of time
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At present, Afnib, as one of the 75 overseas special drugs, has been included in the Beijing Pratt & Whitney Health Insurance; in August 2021, it has been included in the Hainan Boao Lecheng Global Special Drug Insurance as one of the 25 domestic drugs
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This means that more patients can benefit from it, greatly improving the affordability of medicines
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  Summary CStone Pharmaceuticals focuses on research, development and commercialization of innovative tumor immunotherapy and precision treatment drugs
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After several years of deep accumulation in clinical development, good news has been heard frequently in the first half of this year.
Two first-of-its-kind products, Taijihua® (Avatinib) and Pugeta® (Platinib), were successfully launched in the market within a short period of time.
Has achieved considerable sales within
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In the future, it will also usher in the approval of a variety of products including Avnibu in the country, the further expansion of product indications, and the continuous improvement of accessibility and affordability
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