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
EcoOnline Recognised as a Leader in Verdantix Green Quadrant: EHS Software 2026 for Third Time21.9.2026 18:43:00 CEST | Press release
EcoOnline achieved highest score for Safety Management and ranked among the top three vendors for Chemicals Management, Training and Contractor Safety with Lone Worker Protection a key differentiator. EcoOnline, the global provider of software that transforms how organisations protect people and the planet, has been recognised for the third consecutive time as a Leader in the independent Verdantix Green Quadrant: EHS Software 2026 report, with market-leading strength in Safety Management. The assessment evaluated leading vendors of environmental, health and safety software vendors across a range of capabilities and customer buying signals. Verdantix recognised EcoOnline’s strength in the areas organisations rely on to protect workers every day: Safety Management, Chemicals Management, AI-enabled Training and Contractor Safety. It reflects the changing needs of EHS buyers, who are increasingly looking for integrated platforms that connect everyday safety with broader operational risk an
rhode Announces the Return of Limited Edition Favorites and New Exclusives at Sephora Across Europe and the U.K.21.9.2026 15:00:00 CEST | Press release
rhode, the beauty brand founded by Hailey Rhode Bieber and part of e.l.f. Beauty (NYSE: ELF), has announced that two community-favorite Peptide Lip Tints and a new Sephora-exclusive bag will launch at Sephora across Europe and the U.K. to celebrate the brand’s launch into Sephora in Europe on September 30, 2026. These items will join the brand’s assortment of high-performance skincare and hybrid makeup. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260921199856/en/ rhode announces the return of limited edition favorites and new exclusives at Sephora across Europe and the U.K. To mark the occasion with Sephora across Europe and the U.K., rhode is offering early access to purchase fan-favorite, previously limited edition Peptide Lip Tint in Pretzel at Sephora in Europe and the U.K. on the brand’s launch date September 30, before the product joins rhode’s permanent assortment globally on rhodeskin.com on October 1 and at all r
Pierre Le Manh to Step Down as PMI President and CEO21.9.2026 14:45:00 CEST | Press release
Project Management Institute (PMI), the leading authority in project management, today announced that Pierre Le Manh has decided to step down as President and Chief Executive Officer, effective September 30, 2026. Johannes Heinlein, Chief Growth Officer, has been appointed Interim President & Chief Executive Officer of PMI, also effective September 30, 2026. Pierre Le Manh joined PMI in September 2022. During his four-year tenure, he led the development and execution of PMI’s current strategy, strengthened its leadership team, expanded its capabilities through acquisitions and partnerships, and positioned PMI for a profession being rapidly transformed by artificial intelligence and a greater focus on project success. “On behalf of the Board, I want to thank Pierre Le Manh for his leadership and his commitment to PMI,” said Ike Nwankwo, Chair of the PMI Board of Directors. “PMI has a clear strategy, a strong leadership team and significant momentum. Pierre leaves the organization well p
Lenovo and Schneider Electric Partner to Bring Decarbonization Tools and Expertise to IT Channel Partners21.9.2026 14:10:00 CEST | Press release
New partnership gives channel partners a practical pathway to measure emissions, build decarbonization roadmaps, and demonstrate sustainability progress Lenovo today announced that Schneider Electric, a global energy technology leader, will join Lenovo 360 Circle as a strategic ally to bring decarbonization expertise and management tools directly to IT channel partners. Lenovo 360 Circle is Lenovo’s global sustainability community, bringing together channel partners worldwide to collaborate on shared challenges, accelerate sustainability transformation, and turn sustainability ambitions into business opportunities. Through its Allyship program, Lenovo 360 Circle connects partners with leading technology and industry organizations to enable collaboration and provide access to specialized expertise that helps partners accelerate their sustainability goals. As its newest strategic ally, Schneider Electric will bring its Decarbonization Champion initiative to the community, giving eligible
Serbian Biotech Startup Takes Its Journey from Belgrade to Cambridge with Documentary on Longevity Science21.9.2026 13:02:00 CEST | Press release
BioEridan, a Serbian biotechnology company backed by Telekom Srbija Group’s TS Ventures Fund, has premiered a documentary charting its journey from an early scientific project in Belgrade to an emerging biotechnology venture focused on longevity research BioEridan, a Serbian biotechnology startup backed by Telekom Srbija Group’s TS Ventures Fund, has premiered a new documentary showcasing its development of underwater Aquafarms and its ambition to contribute to the next generation of longevity science. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260921345879/en/ BioEridan Documentary Premiere BioEridan: Science Beneath the Surface premiered in Belgrade on September 15 before being screened the following day at a UK-Serbia Health, Digital Transformation & Innovation roundtable held at Christ’s College, University of Cambridge, as part of Cambridge Tech Week 2026. The roundtable brought together prominent representatives fr
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