On January 5, 2023 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune, ophthalmology and other major diseases, reported that the New Drug Application (NDA) for parsaclisib (PI3Kδ inhibitor, R&D code: IBI376) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least two previous systemic therapies has been accepted for review by China’s Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) and granted Priority Review designation (Press release, Innovent Biologics, JAN 5, 2023, View Source [SID1234625925]).

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The acceptance and Priority Review designation for this NDA are based on the results from a multi-center, single-arm, open-label pivotal Phase II study conducted in China (NCT04298879), most recently presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting.

As of the December 12, 2021 data cut-off date, the objective response rate (ORR) seen with parsaclisib monotherapy was 86.9% (53/61, 95%CI: 75.8%, 94.2%) in FL patients who had received at least two previous systemic treatments (n=61), 19 patients (31.1%) had a complete response (CR) and 34 patients (55.7%) achieved a partial response (PR). The median duration of response (DOR) and median progression-free survival (PFS) were not yet achieved, and the majority of patients continued to be in remission. Among the 61 patients treated with parsaclisib, twenty-seven patients (44.3%) experienced grade ≥ 3 treatment emergent adverse events (TEAEs), and the most common grade ≥ 3 TEAEs was a decrease in neutrophil count (n=10, 16.4%). The results also showed that parsaclisib was generally well tolerated with a manageable safety profile.

Dr. Weili Zhao of Shanghai Jiaotong University Ruijin Hospital, commented: "FL is the second most prevalent type of non-Hodgkin’s lymphoma (NHL), accounting for about one-fifth of NHL patients, and is the most common indolent NHL. Although most patients with FL respond to first-line therapy, relapse is common and it is difficult to cure with current therapies, placing a significant burden of disease on patients. We look forward to seeing more patients with relapsed or refractory FL benefit once approved."

Dr. Hui Zhou, Senior Vice President of Innovent, stated: "Treatment options for relapsed or refractory FL remain limited and there is a huge unmet clinical need. The NDA for parsaclisib in China was accepted and granted Priority Review designation, which is a milestone for the clinical research for parsaclisib, and if approved, will expand Innovent’s pipeline with one more innovative product in the field of hematology. We will actively cooperate with regulatory authorities and hope to obtain early approval of this indication, which could lead to more treatment options for patients with relapsed or refractory follicular lymphoma."

About Follicular Lymphoma

According to GLOBOCAN 2020 estimates, there were approximately 93,000 new cases of non-Hodgkin lymphoma (NHL) in China. Follicular lymphoma (FL) is the second most common NHL, accounting for 22% – 35% of NHL patients in Western countries and 8.1% – 23.5% of NHL patients in China. 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 an indolent lymphoma, where current immunochemotherapy is efficacious, FL may still relapse and transform into an aggressive lymphoma, which may lead to death within 1 to 2 years. There is an unmet medical need for treatment options for recurrent/refractory follicular lymphoma.

About Parsaclisib

Parsaclisib is a highly selective, next-generation investigational novel oral inhibitor of phosphatidylinositol 3-kinase delta (PI3Kδ) discovered by Incyte. Pivotal trials of parsaclisib in combination with ruxolitinib for the treatment of patients with myelofibrosis are underway.

In December 2018, Innovent and Incyte entered into a strategic collaboration for three clinical-stage product candidates, including parsaclisib (PI3Kδ inhibitor). Under the terms of the collaboration agreement, Innovent has received the rights to develop and commercialize parsaclisib in Mainland China, Hong Kong, Macau and Taiwan.