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Takeda Pharmaceutical Co.
, Ltd.
Phase 2 Pevonedistat-2001 trial evaluated pevonedistat combined with azacitidine vs.
azacitidine alone in the treatment of rare leukemia patients, including higher-risk myelodysplastic syndrome (HR-MDS)
.
Takeda pevonedistat is a first-in-class NEDD8 activating enzyme (NAE) inhibitor that causes cancer cell death by disrupting protein homeostasis
.
In the phase 2 study for the treatment of HR-MDS, high-risk CMML (HR-CMML), and AML patients, and the phase 1 study for the treatment of AML patients, pevonedistat combined with azacitidine showed good clinical activity
The Pevonedistat-2001 trial is a proof-of-concept study for patients with HR-MDS, high-risk chronic myelomonocytic leukemia (HR-CMML), and low-blastic acute myeloid leukemia (LB-AML)
.
The results of the study show that pevonedistat combined with azacitidine in the treatment of HR-MDS is superior to azacitidine monotherapy in multiple efficacy endpoints, including prolonging overall survival (23.
At the end of July 2020, the US FDA granted pevonedistat a breakthrough therapy designation for the treatment of HR-MDS patients
.
Unfortunately, in the Phase 3 clinical trial PANTHER study (Pevonedistat-3001, NCT03268954) published a few days ago, no positive results were observed
.
On September 2, Takeda Pharmaceutical announced that the Phase 3 PANTHER study (Pevonedistat-3001, NCT03268954) did not reach the pre-set statistical significance in the primary endpoint of event-free survival (PFS)
.
It is reported that the test was carried out in patients with high-risk myelodysplastic syndrome (HR-MDS), chronic monocytic leukemia (CMML), and hypomyelocytic acute myeloid leukemia (LB-AML), and evaluated the combination of pevonedistat and azacitidine Whether first-line treatment can improve EFS compared with azacitidine alone
.
The events in this study are defined as the death or conversion of HR-MDS or CMML patients to AML, whichever occurs first, and the death of AML patients
In the study, the safety profile of the combination regimen of pevonedistat and azacitidine was consistent with previously reported data
.
The complete research data will be announced at an upcoming medical conference
After searching the US clinical trial database (clinicaltrials.
In addition, the company is also evaluating pevonedistat's multiple combination regimens in a number of phase 2 clinical studies, including: pevonedistat+venecla+azacitidine regimen for the treatment of adult patients with AML who are not suitable for intensive chemotherapy, pevonedistat+decitabine +Cidauridine regimen in the treatment of adult patients with HR-MDS, pevonedistat+Keytruda regimen in the treatment of dMMR/MSI-H metastatic or locally advanced unresectable solid tumors, pevonedistat+chemotherapy in the treatment of mesothelioma and non-small cell lung cancer
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