New oral drug Inqovi for myelodysplastic syndrome enters NCCN guidelines

New oral drug Inqovi for myelodysplastic syndrome enters NCCN guidelines.   TRI can help doctors better formulate tumor treatment plans, submit treatment results, and alleviate the suffering of patients.

Recently, the hypomethylation drug Inqovi (decitabine and Cedazuridine) oral tablet, which has been approved by the FDA, was officially included in the latest version of the National Comprehensive Cancer Network (NCCN) “Clinical Practice Guidelines” for the treatment of myelodysplastic syndromes Sign (MDS) in adult patients.

“NCCN Guidelines” recommend that in the treatment of adult patients with MDS, the oral tablet Inqovi can be used as a substitute for intravenous decitabine. The clinical manifestations of these MDS patients are marked cell reduction or myeloblastosis, severe anemia or transplant candidates.

In the special period of the global COVID-19 epidemic, Inqovi oral tablets can reduce the number of hospital visits and reduce the risk of infection for patients.

▌MDS: The “little brother” of leukemia, the hematology treatment problem

Myelodysplastic syndrome (MDS) is a group of heterogeneous myeloid clonal diseases originating from hematopoietic stem cells. It is characterized by abnormal development of bone marrow, red blood cells and megakaryocyte progenitor cells, clinical manifestations and cell line reduction and reduction The degree is related.

MDS is also called “pre-leukemia”. It can develop at any age. About 80% of patients are older than 60 years old, and there are more men than women. Although it is called “early”, it does not mean that it can be ignored.

At present, MDS patients are divided into low-risk groups and relatively high-risk groups at home and abroad.

The treatments of the low-risk group mainly include promotion of hematopoiesis, differentiation induction, and symptomatic supportive treatment; in addition to the above therapies, the treatment of the higher-risk group also includes demethylation therapy, targeted therapy, combined chemotherapy and hematopoietic stem cell transplantation. Hematopoietic stem cell transplantation is currently the only cure for MDS.

High-risk MDS will transform into acute myeloid leukemia. Such patients have a short survival time. Patients mostly die from complications (infection and bleeding) related to cytopenia or AML, and the prognosis is extremely poor.

In recent years, there has been relatively little progress in new drugs in the field of MDS, and treatment options are limited. Supportive therapy and immunotherapy to promote hematopoietic function are the mainstays, which are still treatment problems faced by hematologists.

▌Oral new drugs are written in the guide!

Inqovi is an oral tablet consisting of a fixed-dose cytidine deaminase inhibitor Cedazuridine and a demethylating agent Decitabine.

Decitabine was approved in 2006 to treat MDS. It is a specific DNA methylation transferase inhibitor that can reverse the DNA methylation process and activate inactivated tumor suppressor genes. Studies have confirmed that low-dose decitabine is very effective for patients with MDS who have transformed into leukemia.

Cedazuridine can inhibit the cytidine deaminase in the intestines and liver, and avoid the degradation of Decitabine. Through oral administration for 5 consecutive days, Inqov can also achieve the same exposure concentration as decitabine intravenous infusion. The results of Phase 1 and Phase 2 clinical studies have been published in The Lancet and Blood respectively.

In terms of medication, Inqovi needs to be taken on an empty stomach. The dose is 1 tablet/day for 5 consecutive days, and every 28 days is a cycle.

▌TRI: Precisely predict the treatment plan for high-risk patients

Previously, the results of two major hematological tumor clinical studies (myCare-009-01 and myCare-009-02) showed:

Compared with the treatment plan prescribed by a specialist, TRI Singula can more accurately predict the treatment response of patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).

◆In the myCare-009-02 study, TRI Singula accurately predicted the response of 73.3% of MDS patients with a sensitivity of 97.0% and a specificity of 68.0%, while the response rate of doctor-prescribed treatment was only 37.7%.

It can be seen that TRI Singula can be used as a significant predictor of overall survival rate for MDS patients, and is expected to exceed the response rate of doctors prescribed treatment.

These studies prove that TRI Singula is a great leap in personalized medicine for hematological tumors. Most patients with MDS have multiple molecular variants, each of which affects the patient’s response to treatment.

Singula is a breakthrough technology that can biologically simulate the response of MDS patients with multiple mutations to specific treatments, and then generate very accurate personalized treatment response prediction reports. This new technology is expected to increase the response rate of MDS treatment and improve patient prognosis.

▌How do high-risk patients seize the “prime time” for treatment

For some high-risk MDS patients, the effect of demethylation drugs (HMA) is often unsatisfactory, and treatment options are more limited, which may quickly transform into acute leukemia. What should these patients do?

To this end, the Good Doctor Tumor Treatment Response Index (TRI) helps such patients to seize 30 days through a precision medicine method that combines molecular genetic testing, in vitro drug sensitivity screening (DSS) and artificial intelligence-driven bio-simulation. “Prime time” to develop the best personalized treatment plan.

Top international academic conferences such as 2019 ASH and 2020 ASCO have announced relevant clinical studies on patients with refractory MDS using Good Doctor TRI to guide clinical treatment decisions.

The results show that the personalized treatment plan recommended by TRI can accurately predict the patient’s response to a specific drug (or drug combination), allowing doctors to make more effective treatment decisions based on the response, and enabling some patients to receive allogeneic hematopoietic stem cell transplantation. Achieve cure.

(source:internet, reference only)

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