The PI3Kδ inhibitor introduced by Innovent starts Phase 3 clinical trials in China

The latest announcement on the Chinese drug clinical trial registration and information disclosure platform, the PI3Kδ inhibitor parsaclisib tablets introduced by Indah Biologics Incyte, has initiated a phase 3 international multi-center clinical study for the treatment of subjects with myelofibrosis
.

Previously, the product was used as an indication for relapsed or refractory follicular lymphoma, and it has been included as a breakthrough treatment product by the Center for Drug Evaluation (CDE) of the State Drug Administration of China

Screenshot source: Chinadrugtrials

Parsaclisib is a powerful, highly selective, new-generation phosphatidylinositol 3-kinase δ (PI3Kδ) oral inhibitor discovered and developed by Incyte
.

The PI3K signaling pathway plays an important role in regulating cell growth, movement, survival, metabolism and angiogenesis

In preclinical studies, parsaclisib has shown high selectivity and effectiveness, which means that the drug has the potential to provide clinical benefits for patients with lymphoma and other malignant hematological tumors
.

In December 2018, Innovent and Incyte reached a cooperation and obtained three drug candidates including parsaclisib for hematological diseases and tumor indications in Greater China (including Mainland China, Hong Kong, Macau, and Taiwan) Development and commercialization rights

This time, Cinda Bio and Incyte, etc.
launched a project in China to evaluate the efficacy and safety of parsaclisib combined with Ruxolitinib (Jakafi) in subjects with myelofibrosis who did not respond well to Ruxolitinib (Jakafi).
A randomized, double-blind, placebo-controlled, phase 3 clinical study
.

The purpose of the trial was to evaluate and compare the spleen volume of the parsaclisib+rucotinib group and the placebo+rucotinib group at week 24

It is worth mentioning that parsaclisib has previously presented data from a Phase 2 study at the 2021 American Association for Cancer Research (AACR) annual meeting
.

The results show that for those patients with myelofibrosis who have poor efficacy after standard-dose rucotinib monotherapy, the combination therapy of parsaclisib and rucotinib can improve spleen volume (SVR) and relieve the burden of symptoms.

Myelofibrosis is a type of bone marrow cancer that disrupts the body's normal production of blood cells
.

The patient’s bone marrow will gradually be replaced by fibrotic scar tissue, thereby limiting the bone marrow’s ability to produce blood cells

Reference materials:

Reference materials:

[1] China Drug Clinical Trial Registration and Information Disclosure Platform.

[2]Parsaclisib Plus Ruxolitinib to Treat Myelofibrosis Improves Spleen Size and Symptom Burden.
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