["Wei" has come] The first Bcl-2 inhibitor Weikelai® has been authorized by the latest CSCO guidelines

The 2021 Chinese Society of Clinical Oncology (CSCO) Guidelines Conference was successfully held in Beijing from April 23-24 in a combination of online and offline methods.

This year, the CSCO series of guides ushered in a bumper harvest.
This is also the year with the largest number of guides released and updated in the history of CSCO.

Not only that, but in some disease areas that have been difficult for everyone in the past, such as acute myeloid leukemia (AML), many new drugs and new program recommendations have been added.

As the world's first approved BCL-2 inhibitor, Veneclax tablets (VEN) shined in this CSCO guidelines conference.
It is used in AML, chronic lymphocytic leukemia (CLL), myelodysplastic syndrome (MDS), There are new recommendations for mantle cell lymphoma (MCL) and primary systemic amyloidosis (AL).

On this occasion, Yimaitong specially invited Professor Ma Jun from Harbin Institute of Hematology and Tumor to interpret for us the updated content of VEN in AML and other diseases in the new version of "CSCO Malignant Hematology Guidelines" for readers.

Riptide bravely enter Vinekalla and start the new trend of AML guidelines.
In June last year, in the environment of virus isolation, academic isolation, and non-isolation of public welfare activities, through the joint efforts of national hematology experts, the 2020 "CSCO Malignant Hematological Disease Diagnosis and Treatment Guidelines" Finally landed.

This year, the guidelines elaborated on the diagnosis, classification, treatment, and prognosis of AML patients.

According to Professor Ma Jun, there are many updates on AML in the 2021 new version of the CSCO Guidelines for Diagnosis and Treatment of Hematological Malignancies.
The biggest update highlight is the treatment of adult AML patients ≥ 60 years old.

Regarding the treatment of adult AML patients ≥60 years old, VEN and gemtuzumab, especially VEN, have been added to the new version of the CSCO Guidelines for Diagnosis and Treatment of Hematological Malignancies.
The new version of the guidelines is aimed at Fit, Unfit, and Frail adult AML patients (≥60 years old) Remission induction therapy is recommended for VEN.

For Fit patients and Unfit patients, a level I recommendation was made; for Frail patients, a level III recommendation was also made.

Set sail for Venecla, innovating the new pattern of AML treatment Professor Ma Jun mentioned that VEN is the first BCL-2 inhibitor.
It is different from the previous AML treatment drugs.
It can selectively bind to the BCL-2 anti-apoptotic protein.
This leads to the death of tumor cells.

VEN’s unique anti-tumor mechanism has enabled it to obtain excellent efficacy and good safety in clinical studies.
The long-term follow-up results of the phase 1b study showed that elderly unfit AML patients who achieved complete remission (CR) after VEN+AZA treatment , The median overall survival (OS) can reach 40.
3 months.

The results of the global phase III VIALE-A study (VEN+ AZA vs AZA single agent) confirmed that compared with AZA single agent, VEN+AZA significantly prolonged the patient’s OS for patients who were diagnosed at the beginning of the year, with a median OS of up to 14.
7 months ( vs 9.
6 months), and reduced the patient’s risk of death by 34%; in addition, the patient’s CR+CRi (composite complete remission rate) reached 66.
4%, which was more than 2 times higher than the AZA monotherapy group (28.
3%) In addition, the remission rate of minimal residual disease (MRD) has also increased by nearly three times (23.
4% vs 7.
6%), and patients have achieved a deeper remission.

Professor Ma Jun said that based on the remarkable efficacy and good safety of VEN in AML, the 2021 CSCO Guidelines for the Diagnosis and Treatment of Hematological Malignancies recommends VEN to be used in the first-line treatment for AML patients ≥60 years old.
This is also the update of this guideline.
One of the biggest bright spots.

The new version of the CSCO Guidelines for Diagnosis and Treatment of Hematological Malignancies standardizes the specific usage and dosage of VEN in the recommended population (as shown in the table above), which can guide clinicians in more refined medication.

Unprecedented new version of the guideline, standardizing the principles of veneclax combined medication Professor Ma Jun elaborated on the "Principles of VEN combined with demethylating drugs (HMA) or LDAC for the treatment of AML patients" in the new CSCO guidelines for diagnosis and treatment of hematological malignancies.

He mentioned that the maximum number of cycles for the application of the combined regimen is currently unknown, and it is recommended that patients continue treatment if they can tolerate it and the treatment is effective; when severe bone marrow suppression occurs and the blood picture is difficult to recover, consider shortening HMA and LDAC or VEN The length of treatment.

In addition, it is recommended to refer to the drug instructions and consult the pharmacist for potential drug interactions (such as CYP3A4 or CYP2D6 inhibitors) before use; except for clinical trials, it is not recommended to add a third drug to the two-drug combination program.

For newly treated AML patients, if necessary, hydroxyurea can be used to make the white blood cell count <25000/ml before treatment; if there are indications for the prevention of fungal therapy, the dose of VEN can be reduced according to the instructions.

Attention should be paid to tumor lysis syndrome during the first course of treatment.
It is recommended to be hospitalized during the first course of treatment, especially during the dose-climbing phase; blood picture changes should be monitored regularly after the start of treatment, and blood transfusion support should be given if necessary.
It is recommended to use it after treatment.
Growth factors promote blood recovery; bone marrow assessment is performed on the 21st to 28th day of treatment; if bone marrow blasts are less than 5%, treat the symptoms accordingly.

For the second course of treatment and subsequent treatments, attention should be paid to monitoring the blood picture changes, and regular bone puncture assessments.
If the blood picture has clearly recovered, continue to the next course of treatment, with a maximum interruption of 14 days between each course; if persistent bone marrow suppression occurs, bone should be performed Perform assessment to rule out the possibility of recurrence; if the morphological remission is not obtained in the second course of treatment, it is recommended that the patient participate in clinical trials.
When there is no clinical trial available, if the toxic reaction is controllable, the treatment will be adjusted to the patient's tolerance.

For patients with relapsed and refractory AML, the specific treatment can refer to patients with newly treated AML, and preventive treatment of fungal infections is recommended for patients with indications.

Full bloom of Venecla, helping the new development of hematological tumors in the future Professor Ma Jun also said that in addition to AML, the VEN that was written into the guidelines this time has also been updated in many other disease fields.

For example, CLL patients who are newly treated or relapsed and refractory, have treatment indications, patients with relapsed AL, and MCL patients who have relapsed and refractory.

In addition, experts and scholars also recommend adding a "small molecule targeted drugs" column to the treatment of MDS patients, and mentioned that some previous research data have shown that VEN and IDH1/2 inhibitors have an effect on HMA refractory diseases.
The efficacy of high-risk MDS patients, but its optimal dose and course of treatment still need subsequent optimization.

Professor Ma Jun said, “The new drug VEN has not been clinically approved for less than a year, and it has been included in the new version of the CSCO Guidelines for Diagnosis and Treatment of Hematological Malignancies, adding a powerful'weapon' for hematologists and also for the clinical treatment of AML patients.
Brings more choices.

" Not only that, VEN has become a new standard for AML treatment, and it may also trigger a positive cycle, such as accelerating the development of new drugs, promoting scientific research, further standardizing clinical drug use, discovering more problems in practice, and further improving in the future guide! The update of the new version of the CSCO guidelines can guide hematological oncologists’ clinical medication more standardized, improve the level of diagnosis and treatment of grassroots doctors, further promote the formation of a standardized diagnosis and treatment system in various regions, and better benefit hematological cancer patients, and realize the "Healthy China 2030" plan as soon as possible the goal! Professor Ma Jun, Chief Physician and Doctoral Supervisor, Director of Harbin Institute of Hematological Oncology, Chairman of the Supervisory Committee of the Chinese Society of Clinical Oncology (CSCO), Vice Chairman of the Asian Society of Clinical Oncology, Chairman of the CSCO Anti-Leukemia Alliance, Vice President of the Chinese Medical Doctor Association The Vice President of the Chinese Medical Doctor Association's Oncology Branch Venecla Tablets was approved in China.
Indications: combined with azacitidine to treat newly diagnosed adult AML patients who are not suitable for strong induction chemotherapy due to comorbidities, or are ≥75 years of age.

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