{"id":394489,"date":"2020-12-07T10:03:16","date_gmt":"2020-12-07T15:03:16","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=394489"},"modified":"2020-12-07T10:03:16","modified_gmt":"2020-12-07T15:03:16","slug":"incyte-announces-parsaclisib-treatment-results-in-high-rate-of-rapid-and-durable-responses-in-patients-with-relapsed-or-refractory-b-cell-non-hodgkin-lymphomas","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/incyte-announces-parsaclisib-treatment-results-in-high-rate-of-rapid-and-durable-responses-in-patients-with-relapsed-or-refractory-b-cell-non-hodgkin-lymphomas\/","title":{"rendered":"Incyte Announces Parsaclisib Treatment Results in High Rate of Rapid and Durable Responses in Patients with Relapsed or Refractory B-Cell Non-Hodgkin Lymphomas"},"content":{"rendered":"

<\/p>\n

Incyte Announces Parsaclisib Treatment Results in High Rate of Rapid and Durable Responses in Patients with Relapsed or Refractory B-Cell Non-Hodgkin Lymphomas<\/b><\/p>\n

\n– Data from the CITADEL program of parsaclisib in patients with follicular, marginal zone and mantle cell lymphomas were accepted for presentation at the 62nd American Society of Hematology Annual Meeting and Exposition (ASH 2020)<\/i><\/p>\n

\n– Investor conference call and webcast scheduled for today, December 7, at 10:00 a.m. ET (7:00 a.m. PT)<\/i><\/p>\n

WILMINGTON, Del.–(BUSINESS WIRE<\/a>)–
\nIncyte (Nasdaq:INCY) today announced data from three ongoing Phase 2 studies evaluating parsaclisib, a potent, highly selective, next-generation oral inhibitor of phosphatidylinositol 3-kinase delta (PI3K\u03b4), for the treatment of patients with relapsed or refractory follicular (CITADEL-203), marginal zone (CITADEL-204) and mantle cell (CITADEL-205) lymphomas. These data were accepted for presentation at the 62nd American Society of Hematology Annual Meeting and Exposition (ASH 2020), held virtually from December 5\u20138, 2020.\n<\/p>\n

\nThe primary endpoint for the CITADEL-203, -204 and -205 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.\n<\/p>\n

\nEligible 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.\n<\/p>\n

Key results from the CITADEL studies include: <\/span><\/b><\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
\n

\n\u00a0\n<\/p>\n<\/td>\n

\n

ORR (95% CI), %<\/b><\/p>\n<\/td>\n

\n

mDOR (95% CI), <\/b><\/p>\n

months<\/b><\/p>\n<\/td>\n

\n

mPFS (95% CI), <\/b><\/p>\n

months<\/b><\/p>\n<\/td>\n

\n

mOS (95% CI), <\/b><\/p>\n

months<\/b><\/p>\n<\/td>\n<\/tr>\n

\n

CITADEL-203: R\/R Follicular Lymphoma<\/b><\/p>\n<\/td>\n<\/tr>\n

\n

\nDG (N=95)\n<\/p>\n<\/td>\n

\n

\n75 (65-83)\n<\/p>\n<\/td>\n

\n

\n14.7 (12.0-17.5)\n<\/p>\n<\/td>\n

\n

\n15.8 (13.8-19.1)\n<\/p>\n<\/td>\n

\n

\n–\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nAll (N=118)\n<\/p>\n<\/td>\n

\n

\n73 (64-81)\n<\/p>\n<\/td>\n

\n

\n15.9 (12.0-NE)\n<\/p>\n<\/td>\n

\n

\n15.8 (13.2-19.3)\n<\/p>\n<\/td>\n

\n

\n–\n<\/p>\n<\/td>\n<\/tr>\n

\n

CITADEL-204: R\/R Marginal Zone Lymphoma<\/b><\/p>\n<\/td>\n<\/tr>\n

\n

\nDG (N=72)\n<\/p>\n<\/td>\n

\n

\n56.9 (44.7-68.6)\n<\/p>\n<\/td>\n

\n

\nNR (8.1-NE)\n<\/p>\n<\/td>\n

\n

\nNR (11.0-NE)\n<\/p>\n<\/td>\n

\n

\n–\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nAll (N=100)\n<\/p>\n<\/td>\n

\n

\n57.0 (46.7-66.9)\n<\/p>\n<\/td>\n

\n

\n12.0 (9.3-NE)\n<\/p>\n<\/td>\n

\n

\n19.4 (13.7-NE)\n<\/p>\n<\/td>\n

\n

\n–\n<\/p>\n<\/td>\n<\/tr>\n

\n

CITADEL-205: R\/R Mantle Cell Lymphoma (BTK Inhibitor Treatment Naive)<\/b><\/p>\n<\/td>\n<\/tr>\n

\n

\nDG (N=77)\n<\/p>\n<\/td>\n

\n

\n71 (60-81)\n<\/p>\n<\/td>\n

\n

\n9.0 (6.7-14.7)\n<\/p>\n<\/td>\n

\n

\n11.1 (8.3-NE)\n<\/p>\n<\/td>\n

\n

\nNR (NE-NE)\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nAll (N=108)\n<\/p>\n<\/td>\n

\n

\n70 (61-79)\n<\/p>\n<\/td>\n

\n

\n14.7 (7.7-NE)\n<\/p>\n<\/td>\n

\n

\n11.1 (8.3-19.2)\n<\/p>\n<\/td>\n

\n

\nNR (NE-NE)\n<\/p>\n<\/td>\n<\/tr>\n

\n

CITADEL-205: R\/R Mantle Cell Lymphoma (Previously Treated with Ibrutinib)<\/b><\/p>\n<\/td>\n<\/tr>\n

\n

\nDG (N=41)\n<\/p>\n<\/td>\n

\n

\n29 (16-46)\n<\/p>\n<\/td>\n

\n

\n3.7 (1.9-NE)\n<\/p>\n<\/td>\n

\n

\n3.7 (1.8-4.1)\n<\/p>\n<\/td>\n

\n

\n11.2 (7.9-NE)\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nAll (N=53)\n<\/p>\n<\/td>\n

\n

\n25 (14-38)\n<\/p>\n<\/td>\n

\n

\n3.7 (1.9-NE)\n<\/p>\n<\/td>\n

\n

\n3.7 (1.8-3.9)\n<\/p>\n<\/td>\n

\n

\n11.2 (7.9-17.1)\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nR\/R: relapsed or refractory; ORR: objective response rate; mDOR: median duration of response (reported for responders); mPFS: median progression-free survival; mOS: median overall survival; DG: daily dosing group; BTK: Bruton\u2019s tyrosine kinase.\n<\/p>\n<\/td>\n<\/tr>\n<\/table>\n

\nParsaclisib was generally well tolerated in all studies with a manageable safety profile.\n<\/p>\n

\n\u201cData from the CITADEL studies presented at ASH 2020 are very promising and they highlight the potential of parsaclisib to become a meaningful treatment for patients with relapsed or refractory follicular, marginal zone or mantle cell lymphomas,\u201d said Peter Langmuir, M.D., Group Vice President, Oncology Targeted Therapies, Incyte. \u201cWe look forward to continuing our work as we seek to bring this medicine to patients.\u201d\n<\/p>\n

\nPresentations are available on the ASH website at https:\/\/www.hematology.org\/meetings\/annual-meeting<\/a>; #338 (Oral presentation, CITADEL-204), #2935 (Poster, CITADEL-203), #1121 (Poster, CITADEL-205), #2044 (Poster, CITADEL-205).<\/p>\n

About Follicular, Marginal Zone and Mantle Cell Lymphomas <\/b><\/p>\n

\nNon-Hodgkin lymphoma (NHL) is a type of cancer that starts in the lymphocytes, a type of white blood cell. Follicular lymphoma (FL), marginal zone lymphoma (MZL) and mantle cell lymphoma (MCL) are forms of B-Cell NHLs. FL and MZL are indolent or slow growing lymphomas; MCL is an aggressive or rapidly developing form. There is an unmet medical need for treatment options for patients who are relapsed or refractory to initial therapies.\n<\/p>\n

About CITADEL<\/b><\/p>\n

\nThe CITADEL (Clinical Investigation of TArgeted PI3K-DELta Inhibition in Lymphomas) clinical trial program is evaluating parsaclisib in several ongoing studies as a treatment for adult patients with lymphomas, including:\n<\/p>\n