On December 7, 2020 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 and other major diseases, reported data from two ongoing Phase 2 studies evaluating parsaclisib, an Incyte-discovered, potent, highly selective, next-generation oral inhibitor of phosphatidylinositol 3-kinase delta (PI3Kδ), for the treatment of patients with relapsed or refractory follicular (CITADEL-203) and marginal zone (CITADEL-204) lymphomas (Press release, Innovent Biologics, DEC 7, 2020, View Source [SID1234572379]). These data were accepted for presentation at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (ASH 2020), held virtually from December 5–8, 2020.

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The primary endpoint for the CITADEL-203, and -204 studies is objective response rate (ORR); duration of response (DOR), progression-free survival (PFS), overall survival (OS), safety and tolerability are among the secondary endpoints. All radiology-based endpoints are based on independent review committee (IRC) assessment.

Eligible patients received parsaclisib 20 mg once daily for eight weeks followed by either 20 mg once weekly (weekly-dosing group [WG]) or 2.5 mg once daily (daily-dosing group [DG]). Subsequently, daily dosing was selected as the preferred regimen and patients initially enrolled in the WG were allowed to switch to DG. Data are presented for the DG and all patients.

Key results from the CITADEL studies include:

ORR(95%CI), %

mDOR(95%CI),
months

mPFS(95%CI),
months

CITADEL-203: R/R Follicular Lymphoma

DG (N=95)

75(65-83)

14.7(12.0-17.5)

15.8(13.8-19.1)

All (N=118)

73(64-81)

15.9(12.0-NE)

15.8(13.2-19.3)

CITADEL-204: R/R Marginal Zone Lymphoma

DG (N=72)

56.9(44.7-68.6)

NR(8.1-NE)

NR(11.0-NE)

All N=100)

57.0(46.7-66.9)

12.0(9.3-NE)

19.4(13.7-NE)

R/R: relapsed or refractory; ORR: objective response rate; mDOR: median duration
of response (reported for responders); mPFS: median progression-free survival;
DG:daily dosing group.

Parsaclisib was generally well tolerated in all studies with a manageable safety profile.

"We are glad that data from the CITADEL studies presented at ASH (Free ASH Whitepaper) 2020 appear promising, and they highlight the potential of parsaclisib to become a meaningful treatment for patients with relapsed or refractory B-cell non-Hodgkin lymphomas," said Dr. Hui Zhou, Vice President of Oncology Strategy and Medical Sciences of Innovent, "A pivotal Phase 2 registrational trial to evaluate the efficacy and safety of parsaclisib in patients with recurrent and refractory follicular lymphoma or marginal zone lymphoma in China is also recruiting now, and, if successful, the results of this study may help benefit patients with recurrent or refractory indolent B-cell lymphoma and potentially provide more treatment options to the clinicians that treat them."

Presentations are available on the ASH (Free ASH Whitepaper) website at
View Source; #338 (Oral presentation, CITADEL-204), #2935 (Poster, CITADEL-203).

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 agreement, Innovent has received the rights to develop and commercialize the parsaclisib and two other assets in Mainland China, Hong Kong, Macau and Taiwan. Currently Innovent is conducting a pivotal Phase 2 registrational trial in China to evaluate the efficacy and safety of parsaclisib in patients with recurrent and refractory follicular lymphoma or marginal zone lymphoma.

About Follicular and Marginal Zone Lymphomas

Follicular lymphoma 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/refractory follicular lymphoma.

Marginal zone lymphoma is also a group of indolent B-cell lymphoma. Although BTK inhibitors have been approved in the United States to treat recurrent/refractory marginal zone lymphoma, the reported disease free survival after treatment with BTK inhibitors is short, so new treatments need to be developed on the basis of BTK inhibitors.

About Parsaclisib

Parsaclisib is a potent, highly selective, next-generation investigational novel oral inhibitor of phosphatidylinositol 3-kinase delta (PI3Kδ). It is currently under evaluation as a monotherapy in several ongoing Phase 2 trials as a 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 underway; and there are plans to initiate a trial to evaluate parsaclisib in combination with tafasitamab for B-cell malignancies.

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 agreement, Innovent has received the rights to develop and commercialize parsaclisib and two other assets in Mainland China, Hong Kong, Macau and Taiwan.