DE-INCYTE
7.12.2020 16:02:14 CET | Business Wire | Press release
Incyte (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 (PI3Kδ), 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 5–8, 2020.
The 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.
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 |
mOS (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) |
- |
CITADEL-205: R/R Mantle Cell Lymphoma (BTK Inhibitor Treatment Naive) |
||||
DG (N=77) |
71 (60-81) |
9.0 (6.7-14.7) |
11.1 (8.3-NE) |
NR (NE-NE) |
All (N=108) |
70 (61-79) |
14.7 (7.7-NE) |
11.1 (8.3-19.2) |
NR (NE-NE) |
CITADEL-205: R/R Mantle Cell Lymphoma (Previously Treated with Ibrutinib) |
||||
DG (N=41) |
29 (16-46) |
3.7 (1.9-NE) |
3.7 (1.8-4.1) |
11.2 (7.9-NE) |
All (N=53) |
25 (14-38) |
3.7 (1.9-NE) |
3.7 (1.8-3.9) |
11.2 (7.9-17.1) |
R/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’s tyrosine kinase. |
||||
Parsaclisib was generally well tolerated in all studies with a manageable safety profile.
“Data 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,” said Peter Langmuir, M.D., Group Vice President, Oncology Targeted Therapies, Incyte. “We look forward to continuing our work as we seek to bring this medicine to patients.”
Presentations are available on the ASH website at https://www.hematology.org/meetings/annual-meeting ; #338 (Oral presentation, CITADEL-204), #2935 (Poster, CITADEL-203), #1121 (Poster, CITADEL-205), #2044 (Poster, CITADEL-205).
About Follicular, Marginal Zone and Mantle Cell Lymphomas
Non-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.
About CITADEL
The 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:
- CITADEL-203 (NCT03126019 ) is evaluating patients with relapsed or refractory follicular lymphoma (FL) Grade 1, 2 or 3a who received at least two prior systemic therapies, had an Eastern Cooperative Oncology Group performance status (ECOG PS) ≤2, and were ineligible for hematopoietic stem cell transplantation (HSCT).
- CITADEL-204 (NCT03144674 ) is evaluating patients with relapsed or refractory marginal zone lymphoma (MZL) who received at least one prior systemic therapy and were Bruton’s tyrosine kinase (BTK) inhibitor treatment naive. Patients with prior ibrutinib treatment were initially allowed to enroll; however, the cohort was terminated due to slow enrollment. Eligible patients had radiologically measurable lymphadenopathy or extranodal lymphoid malignancy (or histologically confirmed bone marrow infiltration in cases of splenic MZL), and an ECOG PS ≤2.
- CITADEL-205 ( NCT03235544 ) is evaluating patients with relapsed or refractory mantle cell lymphoma (MCL), who received one to three prior systemic therapies and were either naive to or were previously treated with a BTK inhibitor. Eligible patients had an ECOG PS ≤2, and radiologically measurable lymphadenopathy or extranodal lymphoid malignancy.
Patients eligible for each trial were allocated to receive 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 the WG patients were allowed to switch to DG. Prophylaxis for Pneumocystis jirovecii pneumonia (PJP) was required.
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. 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.
Conference Call Information
Incyte will host an investor conference call and webcast at 10:00 a.m. ET (7:00 a.m. PT) today, December 7, 2020—the call and webcast can be accessed via the Events and Presentations tab of the Investor section of Incyte.com and it will be available for replay for 90 days.
To access the conference call, please dial 877-407-3042 for domestic callers or +1 201-389-0864 for international callers. When prompted, provide the conference identification number, 13713399.
About Incyte
Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte .
Forward-Looking Statements
Except for the historical information set forth herein, the matters set forth in this press release, including statements about the potential of parsaclisib to provide a meaningful treatment for patients with non-Hodgkin lymphomas, including follicular lymphoma, marginal zone lymphoma and mantle cell lymphoma, the CITADEL clinical program and other development plans for parsaclisib, including in combination with tafasitamab and with ruxolitinib, and the safety and efficacy of parsaclisib in patients with non-Hodgkin lymphomas contain predictions, estimates and other forward-looking statements.
These forward-looking statements are based on the Company’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the FDA; the efficacy or safety of the Company’s products; the acceptance of the Company’s products and the products of the Company’s collaboration partners in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; greater than expected expenses; expenses relating to litigation or strategic activities; and other risks detailed from time to time in the Company’s reports filed with the Securities and Exchange Commission, including its Form 10-Q for the quarter ended September 30, 2020. The Company disclaims any intent or obligation to update these forward-looking statements.
View source version on businesswire.com: https://www.businesswire.com/news/home/20201207005129/en/
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
IQM Quantum Computers Becomes First European Quantum Computing Company Listed on a Major U.S. Exchange2.7.2026 16:47:00 CEST | Press release
IQM begins trading on Nasdaq Global Select Market under the ticker symbol “IQMX” Company enters next phase of growth as a publicly traded leader in full-stack superconducting quantum computing IQM maintains a strong pro forma cash position of EUR 337 million IQM Quantum Computers (Nasdaq: IQMX) (“IQM”, “IQM Quantum Computers” or the “Company”), a global leader in full-stack superconducting quantum computers, today became a publicly traded company following the completion of its business combination with Real Asset Acquisition Corp. (“RAAQ”). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260702960460/en/ IQM Quantum Computers Becomes First European Quantum Computing Company Listed on a Major U.S. Exchange The company’s American Depositary Shares begin trading today on the Nasdaq Global Select Market under the ticker symbol “IQMX”. The listing marks a major milestone for IQM establishing the company as the first European quan
GigaDevice Launches First GD24CL Series I²C EEPROM, Further Expanding Its Non-Volatile Memory Portfolio2.7.2026 16:00:00 CEST | Press release
GigaDevice, a leading semiconductor company specializing in Flash memory, 32-bit microcontrollers (MCUs), sensors, and analog products, announced today the launch of its new GD24CL series I²C EEPROM. The series delivers outstanding performance, comprehensive security protection mechanisms, and excellent reliability that addresses the stringent requirements for stable and long-term storage of critical configuration data. These offered features will benefit applications in industrial, energy, Internet-of-Things (IoT), data centers, and networking. As GigaDevice’s first EEPROM product series, the launch further enhances the company’s non-volatile memory portfolio and provides customers with more dynamic storage solutions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260702394554/en/ GigaDevice Launches First GD24CL Series I²C EEPROM, Further Expanding Its Non-Volatile Memory Portfolio. The GD24CL series is designed with high
Medical University of Graz Enrolls First Patient in DEEPER CHALLENGE Trial Evaluating Spur® Peripheral Retrievable Scaffold System in a Select CLTI Cohort2.7.2026 13:00:00 CEST | Press release
Reflow Medical, Inc. announces that the Medical University of Graz has enrolled the first patient in the DEEPER CHALLENGE clinical trial. This investigator-initiated, single-center, single-arm, prospective study, supported by a grant, investigates early vessel recoil following below-the-knee treatment using the Spur® Peripheral Retrievable Scaffold System in combination with a commercially available drug-coated balloon. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260701995624/en/ The study investigates early vessel recoil following below-the-knee treatment using the Spur® Peripheral Retrievable Scaffold System in combination with a commercially available drug-coated balloon. The study plans to enroll up to 40 patients with chronic limb-threatening ischemia (CLTI) across two distinct cohorts: patients with diabetes and patients with end-stage renal disease receiving hemodialysis for at least six months, with women comprisi
Compass Pathways Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)2.7.2026 12:30:00 CEST | Press release
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that Compass granted equity awards under the Compass Pathways plc 2026 Inducement Plan to eight newly hired non-executive employees. The equity awards were granted on July 1, 2026 and consisted of options to purchase an aggregate of 63,685 shares and restricted share units or, in the case of employees in the United Kingdom nominal cost options, covering an aggregate of 30,300 shares. The options have an exercise price per share equal to $13.29, the closing price of the Company’s American Depositary Shares on the Nasdaq Global Select Market on the grant date, and will vest over a four-year period with 25% vesting on the first anniversary of the date of the grant and the remaining 75% vesting in equal monthly installments over the three-year period thereafter, subject to each employee’s continued employment. The restricted sh
Infobip Launches PitchMate — An AI Fan Companion for Global Football2.7.2026 12:00:00 CEST | Press release
Two AI agents. Two global sports. One platform redefining what it means to be a fan. Global AI-first cloud communications platform Infobip launched PitchMate, a new AI-powered conversational agent that brings football fans closer to the action of the world’s biggest football tournament. Purpose-built for the global football audience, PitchMate joins the TGR Haas F1 Team RaceMate — Infobip’s AI fan engagement solution for the TGR Haas F1 Team — in demonstrating how conversational AI is transforming fan engagement across sports worldwide. RaceMate, launched last April for this year’s motorsport season, is an AI agent on WhatsApp and Apple Messages for Business that puts TGR Haas F1 Team fans at the center of the action. It delivers real-time race data, personalized content, team radio highlights, trivia, and native multilingual support, turning passive viewers into active participants through natural, human-like conversations across every race weekend. Since its launch, RaceMate has reac
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom