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—Among 15 patients with evaluable efficacy, 7 patients (47%) achieved complete bone marrow remission, 5 patients (33%) had stable disease, and the overall disease control rate reached 80%; —Median overall survival of patients with complete bone marrow remission Significantly better than patients who have not achieved complete bone marrow remission or disease progression; Shanghai, China and Hong Kong, June 9, 2021-Karyopharm Therapeutics Inc.
(Nasdaq Stock Code: KPTI), a partner of Deqi Pharmaceuticals, in the United States in 2021 At the annual meeting of the Society of Clinical Oncology (ASCO), the latest clinical data of eltanexor in the treatment of myelodysplastic syndrome (MDS) refractory to demethylation drugs (HMA) was announced
.
This trial is a phase I/II clinical study aimed at evaluating single-agent eltanexor in the treatment of higher-risk MDS patients, that is, according to the International Prognostic Scoring System (IPSS) assessed as intermediate-risk-2 or high-risk MDS patients, and the proportion of bone marrow blasts It is 5-19%
.
Patients enrolled in the trial were divided into two dose groups for evaluation: 10 mg (n=5) and 20 mg (n=10) per day, 5 days a week, 28 days as a cycle
.
Among the 20 patients enrolled in the group, 15 patients can be evaluated for efficacy
.
The results showed that among patients whose efficacy can be evaluated, 7 patients (47%) achieved complete bone marrow remission (mCR), 5 patients (33%) had stable disease (SD), and the total disease control rate (mCR+SD) reached 80% ( The total disease control rate of all enrolled patients was 60%)
.
In the 10 mg dose group (n=5), all patients had clinical benefit, 3 patients (60%) achieved complete bone marrow remission, and 2 patients (40%) had stable disease
.
In the 20 mg dose group (n=10), 4 cases (40%) achieved complete bone marrow remission, and 3 cases (30%) had stable disease
.
Among the 15 patients, 4 patients achieved hematological improvement (HI) and were free from blood transfusion dependence for at least 8 weeks.
Among them, 2 patients achieved tertiary hematological improvement
.
The overall survival of patients with complete bone marrow remission (n=7) was significantly better than that of patients who did not achieve complete bone marrow remission (n=8).
The median overall survival was 11.
86 months and 8.
67 months, respectively (hazard ratio [HR]= 0.
27, p=0.
05), and was significantly better than the overall survival of patients with disease progression (PD) (n=3, median overall survival 3.
15 months, hazard ratio [HR]=0.
23, p=0.
04)
.
Patients with disease control (n=12) had a longer median overall survival than patients with disease progression (9.
86 vs 3.
15 months, hazard ratio [HR]=0.
38, p=0.
09)
.
The median overall survival of patients with improved hematology was 10.
58 months
.
MDS patients refractory to demethylation drugs have limited treatment options and poor prognosis.
The median overall survival (mOS) is only 4-6 months
.
Eltanexor is a new generation of oral XPO1 inhibitors.
In preclinical studies, it has shown stronger anti-tumor activity and lower blood-brain barrier penetration than Celiniso (the first-generation XPO1 inhibitor)
.
Therefore, eltanexor can achieve better dosing frequency while reducing central nausea
.
Deck Pharmaceuticals has reached a strategic cooperation with Karyopharm and obtained the development and commercialization rights of four drug candidates including eltanexor in 17 Asia-Pacific markets
.
At present, Deqi Pharmaceuticals is carrying out clinical trials of eltanexor in the treatment of patients with MDS and advanced solid tumors in China.
Among them, a phase I/II clinical trial (HATCH) of eltanexor in the treatment of patients with MDS has completed the first patient administration
.
About Eltanexor (ATG-016) Eltanexor is a new generation selective nuclear export inhibitor (SINE) compound
.
Compared with the first generation of SINE compounds, eltanexor has a lower blood-brain barrier penetration and a wider therapeutic window, so it has better tolerability, which can achieve more frequent administration and higher doses.
Prolonged drug exposure
.
Eltanexor will be suitable for a wider range of indications
.
About Deqi Pharmaceuticals Deqi Pharmaceuticals Co.
, Ltd.
("Deqi Pharmaceuticals" for short, Hong Kong Stock Exchange stock code: 6996.
HK) is a leading R&D-driven biopharmaceutical company, committed to providing the most advanced products for patients in Asia Pacific and even the world.
Therapies to treat tumors and other life-threatening diseases
.
Since its official operation in 2017, Deqi Pharmaceuticals has established a rich product pipeline that extends from pre-clinical to clinical stages through cooperative introduction and independent research and development
.
At present, Deqi Pharma has obtained 15 clinical approval documents (IND) in multiple Asia-Pacific markets, and submitted 5 new drug listing applications (NDA)
.
With the vision of "Doctors have no boundaries, innovation and sustainability", Deqi Pharmaceuticals will focus on the early R&D, clinical research, drug production and commercialization of the first and best-in-class therapies to solve urgent clinical needs
.
Forward-looking statements The forward-looking statements made in this article only relate to events or information as of the date when the statement is made in this article
.
Except as required by law, we have no obligation to update or publicly revise any forward-looking statements and unexpected events after the date of forward-looking statements, regardless of whether new information, future events or other circumstances appear
.
Please read this article carefully and understand that our actual future results or performance may differ materially from expectations
.
Statements or references in this article regarding the intentions of any directors or the company were made on the date of publication of this article
.
Any such intentions may change due to future development
.
(Nasdaq Stock Code: KPTI), a partner of Deqi Pharmaceuticals, in the United States in 2021 At the annual meeting of the Society of Clinical Oncology (ASCO), the latest clinical data of eltanexor in the treatment of myelodysplastic syndrome (MDS) refractory to demethylation drugs (HMA) was announced
.
This trial is a phase I/II clinical study aimed at evaluating single-agent eltanexor in the treatment of higher-risk MDS patients, that is, according to the International Prognostic Scoring System (IPSS) assessed as intermediate-risk-2 or high-risk MDS patients, and the proportion of bone marrow blasts It is 5-19%
.
Patients enrolled in the trial were divided into two dose groups for evaluation: 10 mg (n=5) and 20 mg (n=10) per day, 5 days a week, 28 days as a cycle
.
Among the 20 patients enrolled in the group, 15 patients can be evaluated for efficacy
.
The results showed that among patients whose efficacy can be evaluated, 7 patients (47%) achieved complete bone marrow remission (mCR), 5 patients (33%) had stable disease (SD), and the total disease control rate (mCR+SD) reached 80% ( The total disease control rate of all enrolled patients was 60%)
.
In the 10 mg dose group (n=5), all patients had clinical benefit, 3 patients (60%) achieved complete bone marrow remission, and 2 patients (40%) had stable disease
.
In the 20 mg dose group (n=10), 4 cases (40%) achieved complete bone marrow remission, and 3 cases (30%) had stable disease
.
Among the 15 patients, 4 patients achieved hematological improvement (HI) and were free from blood transfusion dependence for at least 8 weeks.
Among them, 2 patients achieved tertiary hematological improvement
.
The overall survival of patients with complete bone marrow remission (n=7) was significantly better than that of patients who did not achieve complete bone marrow remission (n=8).
The median overall survival was 11.
86 months and 8.
67 months, respectively (hazard ratio [HR]= 0.
27, p=0.
05), and was significantly better than the overall survival of patients with disease progression (PD) (n=3, median overall survival 3.
15 months, hazard ratio [HR]=0.
23, p=0.
04)
.
Patients with disease control (n=12) had a longer median overall survival than patients with disease progression (9.
86 vs 3.
15 months, hazard ratio [HR]=0.
38, p=0.
09)
.
The median overall survival of patients with improved hematology was 10.
58 months
.
MDS patients refractory to demethylation drugs have limited treatment options and poor prognosis.
The median overall survival (mOS) is only 4-6 months
.
Eltanexor is a new generation of oral XPO1 inhibitors.
In preclinical studies, it has shown stronger anti-tumor activity and lower blood-brain barrier penetration than Celiniso (the first-generation XPO1 inhibitor)
.
Therefore, eltanexor can achieve better dosing frequency while reducing central nausea
.
Deck Pharmaceuticals has reached a strategic cooperation with Karyopharm and obtained the development and commercialization rights of four drug candidates including eltanexor in 17 Asia-Pacific markets
.
At present, Deqi Pharmaceuticals is carrying out clinical trials of eltanexor in the treatment of patients with MDS and advanced solid tumors in China.
Among them, a phase I/II clinical trial (HATCH) of eltanexor in the treatment of patients with MDS has completed the first patient administration
.
About Eltanexor (ATG-016) Eltanexor is a new generation selective nuclear export inhibitor (SINE) compound
.
Compared with the first generation of SINE compounds, eltanexor has a lower blood-brain barrier penetration and a wider therapeutic window, so it has better tolerability, which can achieve more frequent administration and higher doses.
Prolonged drug exposure
.
Eltanexor will be suitable for a wider range of indications
.
About Deqi Pharmaceuticals Deqi Pharmaceuticals Co.
, Ltd.
("Deqi Pharmaceuticals" for short, Hong Kong Stock Exchange stock code: 6996.
HK) is a leading R&D-driven biopharmaceutical company, committed to providing the most advanced products for patients in Asia Pacific and even the world.
Therapies to treat tumors and other life-threatening diseases
.
Since its official operation in 2017, Deqi Pharmaceuticals has established a rich product pipeline that extends from pre-clinical to clinical stages through cooperative introduction and independent research and development
.
At present, Deqi Pharma has obtained 15 clinical approval documents (IND) in multiple Asia-Pacific markets, and submitted 5 new drug listing applications (NDA)
.
With the vision of "Doctors have no boundaries, innovation and sustainability", Deqi Pharmaceuticals will focus on the early R&D, clinical research, drug production and commercialization of the first and best-in-class therapies to solve urgent clinical needs
.
Forward-looking statements The forward-looking statements made in this article only relate to events or information as of the date when the statement is made in this article
.
Except as required by law, we have no obligation to update or publicly revise any forward-looking statements and unexpected events after the date of forward-looking statements, regardless of whether new information, future events or other circumstances appear
.
Please read this article carefully and understand that our actual future results or performance may differ materially from expectations
.
Statements or references in this article regarding the intentions of any directors or the company were made on the date of publication of this article
.
Any such intentions may change due to future development
.
