Instant Report

Date: 02-Apr-2021

China NMPA Grants Breakthrough Therapy Designation To Innovents Parsaclisib To Treat Relapsed/refractory Follicular Lymphoma

Innovent Biologics Inc, a biopharmaceutical company announced that the Center for Drug Evaluation (CDE) of China's Nation Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for Parsaclisib (IBI376) for the treatment of patients with relapsed/refractory follicular lymphoma (FL).

IBI376 is a phosphatidylinositol 3-kinase delta (PI3Kd) inhibitor originally discovered by Incyte. Innovent owns the rights to develop and commercialize Parsaclisib in greater China.

NMPA grants Breakthrough Therapy Designation to new medicines that are intended to treat serious conditions and where clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint. The BTD designation for Parsaclisib is based on the results observed in an ongoing phase 2 study for the treatment of adults with relapsed or refractory FL being conducted in China (CTR2019239). Parsaclisib is currently in Phase 2 pivotal trials for the treatment of adults with relapsed or refractory follicular or with marginal zone lymphoma.

In clinical studies, Parsaclisib has demonstrated potent and rapid anti-lymphoma activity with promising safety, efficacy, and persistence. Preliminary clinical results of the CITADEL-203 study in relapsed or refractory FL presented at the 62st Annual Meeting of the American Society of Hematology (ASH) held in 2020 highlighted the safety profile, efficacy, and the durability of response of Parsaclisib (Abstract 2935). Study results showed that in the dosing group (N=95), Parsaclisib monotherapy achieved an objective response rate of 75%, with median PFS of 15.8 months in relapsed or refractory FL patients.

Dr. Hui ZHOU, vice president of Medical Science and Strategy Oncology of Innovent stated, "The breakthrough therapy designation from NMPA indicated that Parsaclisib possesses great potential in treating relapsed or refractory follicular lymphoma and we are hopeful that this product can help benefit more patients in the future."

Parsaclisib (IBI376) is an investigational novel oral inhibitor of phosphatidylinositol 3-kinase delta (PI3Kd) isoforms. PI3Kd is an important anticancer target implicated in malignant B-cell growth, survival and proliferation which has demonstrated potency and selectivity in preclinical studies and has potential therapeutic utility in the treatment of patients with hematologic malignancies such as lymphoma.

Parsaclisib is currently under evaluation as a monotherapy in several ongoing phase 2 trials as treatment for non-Hodgkin lymphomas (follicular, marginal zone and mantle cell); and autoimmune hemolytic anemia. Pivotal trials of Parsaclisib in combination with ruxolitinib for the treatment of patients with myelofibrosis are also underway; and there are plans to initiate a trial to evaluate Parsaclisib in combination with tafasitamab for non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL).

In December 2018, Innovent and Incyte entered into a strategic collaboration for three clinical-stage product candidates discovered and developed by Incyte, including Parsaclisib (PI3Kd inhibitor). Under the terms of the agreement, Innovent has received the rights to develop and commercialize Parsaclisib and two other assets in Mainland China, Hong Kong, Macau and Taiwan.

Follicular lymphoma (FL) is a B-cell cancer that originates from the uncontrolled division of specific types of B-cells known as centrocytes and centroblasts. Although it is classified as indolent lymphoma, and the current immunochemotherapy has achieved good efficacy, it still often relapses following by aggressive diseases, which may lead to death within 1 to 2 years. There is an unmet medical need for treatment options for recurrent or refractory follicular lymphoma.