Benzinga | Dec 11, 2021 09:21AM EST

Incyte Announced Updated Data Demonstrating Rapid and Durable Responses of Parsaclisib in Patients with Relapsed or Refractory B-Cell Non-Hodgkin Lymphomas at ASH 2021

Incyte (NASDAQ:INCY) today announced data from three ongoing Phase 2 studies evaluating parsaclisib, an investigational novel potent, highly selective, next-generation oral inhibitor of phosphatidylinositol 3-kinase delta (PI3K), for the treatment of patients with relapsed or refractory follicular lymphoma (FL) (CITADEL-203), marginal zone lymphoma (MZL) (CITADEL-204) and mantle cell lymphoma (MCL) (CITADEL-205). These data were accepted as oral presentations at the 63rd American Society of Hematology Annual Meeting and Exposition (ASH 2021), held December 1114, 2021 in Atlanta, Georgia and virtually.

The primary endpoint for the CITADEL-203, -204 and -205 studies is objective response rate (ORR). Key secondary endpoints include complete response rate (CRR), duration of response (DOR), progression-free survival (PFS), overall survival (OS), safety and tolerability. All radiology-based endpoints are based on independent review committee (IRC) assessment.

Building on previous findings presented at ASH 2020, these updated data from the primary analysis continue to show treatment with parsaclisib resulted in a rapid and durable response with an acceptable safety profile, and supported the New Drug Application (NDA) for parsaclisib, recently accepted by the U.S. Food and Drug Administration (FDA).

R/R: relapsed or refractory; ORR: objective response rate; CRR: complete response rate; mDOR: median duration of response (reported for responders); mPFS: median progression-free survival; mOS: median overall survival; DG: daily dosing group; NE: not estimable; NR: not reached.

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

"We are pleased to share these updated results from the CITADEL studies with the oncology community," said Peter Langmuir, M.D., Group Vice President, Oncology Targeted Therapies, Incyte. "The promising data add to the body of evidence that support parsaclisib, which has the potential to become a meaningful treatment for patients with relapsed or refractory follicular, marginal zone or mantle cell lymphomas, and we look forward to working with the FDA as we strive to bring this therapy to patients."

"Non-Hodgkin lymphoma is composed of varying subtypes and is one of the most common cancers in the United States. Given the fact that a significant subset of those afflicted will not be cured with current options, we need new treatment options," said Tycel Phillips, M.D., Primary Investigator, CITADEL-204 and Associate Professor, Division of Hematology and Oncology, Rogel Cancer Center, University of Michigan. "I am encouraged to see parsaclisib result in rapid and durable responses with a manageable safety profile in patients with a variety of non-Hodgkin lymphomas. The results observed across several key endpoints of the CITADEL studies suggest that parsaclisib may be a favorable treatment option for patients."