Business Wire

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

Share

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 (PI3Kδ), 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 11–14, 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).

Key results from the CITADEL studies include:

 

ORR (95% CI), %

CRR (95% CI), months

mDOR (95% CI), months

mPFS (95% CI), months

 

mOS (95% CI), months

CITADEL-203: R/R Follicular Lymphoma

DG (N=103)

77.7 (68.4–85.3)

19.4 (12.3-28.4)

14.7 (10.4-NE)

15.8 (11.0-NE)

NR (NE-NE)

All (N=126)

75.4 (66.9-82.6)

18.3 (11.9-26.1)

14.7 (12.0-20.3)

14.0 (11.3-19.6)

NR (NE-NE)

CITADEL-204: R/R Marginal Zone Lymphoma

DG (N=72)

58.3 (46.1-69.8)

4.2 (0.9-11.7)

12.2 (8.1-17.5)

16.5 (11.5-20.6)

NR (NE-NE)

All (N=100)

58.0 (47.7-67.8)

6.0 (2.2-12.6)

12.2 (8.1-17.5)

16.5 (13.5-19.6)

NR (NE-NE)

CITADEL-205: R/R Mantle Cell Lymphoma (BTK Inhibitor Treatment Naive)

DG (N=77)

70.1 (58.6-80.0)

15.6 (8.3-25.6)

12.1 (9.0-NE)

13.6 (10.0-16.9)

NR (NE-NE)

All (N=108)

68.5 (58.9-77.1)

17.6 (10.9-26.1)

13.7 (9.0-19.9)

11.99 (8.3-16.9)

NR (NE-NE)

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.”

Presentations can be accessed via the ASH website at https://www.hematology.org/meetings/annual-meeting; #813 (Oral presentation, CITADEL-203), #44 (Oral presentation, CITADEL-204), #382 (Oral presentation, 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 trials to evaluate parsaclisib in combination with tafasitamab, including a pivotal trial in 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.

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 and the ability to enroll subjects in accordance with planned schedules; the effects of the COVID-19 pandemic and measures to address the pandemic on the Company’s clinical trials, supply chain and other third-party providers, sales and marketing efforts and business, development and discovery operations; determinations made by the FDA or other regulatory authorities; the efficacy or safety of the Company’s products; the acceptance of the Company’s products in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; greater than expected expenses, including 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 quarterly report on Form 10-Q for the quarter ended September 30, 2021. The Company disclaims any intent or obligation to update these forward-looking statements.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Media
Jenifer Antonacci +1 302 498 7036
jantonacci@incyte.com

Catalina Loveman +1 302 498 6171
cloveman@incyte.com

Investors
Christine Chiou +1 302 274 4773
cchiou@incyte.com

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

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

Temenos Announces Composable Banking Services on the Temenos Banking Cloud Platform18.1.2022 10:53:00 EET | Press release

Temenos (SIX: TEMN), the banking software company, today announced Composable Banking Services and Capabilities aligned to the BIAN (Banking Industry Architecture Network) service landscape on the Temenos Banking Cloud. In addition, Temenos delivers new banking services and technology advancements that create the market's most comprehensive, cloud-native platform for composable banking. These new banking services are showcased at Temenos Sales Kick-Off, 18-21 January and will be presented at Temenos Community Forum, 17-19 May 2022. Temenos has advanced its technology architecture and banking capabilities to deliver the most open and secure cloud-native platform for composing, extending or deploying banking capabilities at scale. New pre-composed banking services on the Temenos Banking Cloud can be rapidly consumed from a self-service portal, easily configured, extended or deployed anywhere. Composed Temenos Banking Services consist of pre-configured and pre-assembled Temenos Banking Ca

SES Appoints John-Paul Hemingway as Chief Strategy and Product Officer18.1.2022 10:50:00 EET | Press release

SES is adding a new Chief Strategy and Product Officer (CSPO) to its Senior Leadership Team, underscoring SES’s commitment to ideate, build and deliver the services and solutions that create the most value for SES customers and partners, as well as their end-users. John-Paul (JP) Hemingway is charged with translating SES's corporate vision into strategic action for the company's networks and video markets – including its target applications, strategic partnerships, portfolio of solutions, and the space and network assets required to deliver them. The newly-created function brings together the Corporate Strategy, Product, Commercial Operations, Fleet Development, Innovation and Marketing & Communications teams, and is part of SES’s drive to be the most customer-centric, product-led organisation in the industry. With Hemingway’s appointment as CSPO, SES is eliminating the role of SES Networks CEO while retaining the strong focus on its video and networks businesses and leveraging its inn

CSL Behring AG publishes Offer Prospectus on public tender offer for all publicly held shares of Vifor Pharma Ltd.18.1.2022 09:05:00 EET | Press release

Regulatory News: This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220117005418/en/ AD HOC ANNOUNCEMENT PURSUANT TO ART. 53 LR CSL Behring AG, Berne, Switzerland, a wholly-owned subsidiary of global biotechnology leader CSL Limited (ASX: CSL; USOTC: CSLLY), today published the offer prospectus regarding its public tender offer for all publicly held registered shares of Vifor Pharma Ltd. (SIX:VIFN; ISIN:CH0364749348), a global specialty pharmaceutical company with leadership in Iron Deficiency, Nephrology & Cardio-Renal Therapies, as indicated in the pre-announcement of the public tender offer published by CSL Limited on 14 December 2021. The transaction, has been unanimously approved by both companies’ Boards of Directors. The offer price for each registered share of Vifor Pharma Ltd. is USD 179.25 in cash. The public tender offer is subject to the offer conditions set forth in the offer prospectus, which includes the report of

Fujirebio Europe Launches the RoboBlot™ Instrument, a Fully Automated Solution for INNO-LIA® Score Assays18.1.2022 09:00:00 EET | Press release

Fujirebio Europe announced today the commercial launch of the RoboBlot instrument, a closed system for the automated processing of the widely used INNO-LIA Score assays. The instrument is manufactured by Bee Robotics Ltd. and distributed by Fujirebio Europe. The system’s pre-programmed test protocols provide start-to-finish automation of strip-based INNO-LIA Score assays, from sample addition, over strip processing, image capture, to result interpretation and where applicable laboratory information system (LIS) communication. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220117005350/en/ RoboBlot™ - an instrument for fully automated processing of INNO-LIA® tests from sample pipetting to strip reading and LiRAS® interpretation (Photo: Fujirebio) “High throughput testing and more automation are an increasingly pressing need for laboratories. The typical drawbacks of manual testing, such as long hands-on time, inconsistent ass

Fast Growing RegTech SteelEye Reports 88% Growth In 202118.1.2022 08:01:00 EET | Press release

SteelEye, the compliance technology and data analytics firm, has announced a record year of growth. Revenues increased 88 percent year-on-year in 2021 and the company now has over 120 institutional clients worldwide, with new clients including Oppenheimer Europe Ltd and JonesTrading. SteelEye – which is headquartered in the UK and has offices in London, New York, Paris, Bengaluru, and Braga – has seen increasing demand for its services as financial firms’ regulatory compliance needs have grown across the globe. In response, the business expanded to the United States last year, backed by $17 million funding rounds in 2020, and appointed RegTech veteran Brian Lynch to lead its US operations. Pressure from regulators and the increasing need to improve operational efficiency across the industry have encouraged more firms to replace legacy technologies through platforms like SteelEye. This demand is growing exponentially as remote and hybrid work patterns become the norm – requiring firms t

Faster Air Quality Mapping Thanks to Ricardo’s RapidAir Software18.1.2022 03:01:00 EET | Press release

RapidAir®, developed by the global air quality, energy and environment specialists, is the next generation dispersion modelling and policy support platform that enables users to test the impact of scenarios in minutes, supporting the identification of measures that will reduce traffic emissions and consequently improve public health. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220117005253/en/ RapidAir air quality software (Photo: Business Wire) The ground-breaking air quality dispersion modelling software has already been successfully used across Asia, Europe and the UK, supporting Clean Air Zone evaluations, traffic management measures and wider air quality management activities. In response to requests from clients, including transport and health professionals, Ricardo has developed a cloud-based RapidAir software, complimenting its consultancy offering and making the capabilities of RapidAir more accessible to profess

Megaport Announces Partnership with TD SYNNEX as Leading Network as a Service (NaaS) Vendor Partner18.1.2022 00:00:00 EET | Press release

Megaport Limited (ASX: MP1) ("Megaport"), a global leading Network as a Service (NaaS) provider, today announces a partnership with TD SYNNEX, a global IT distributor and solutions aggregator, to make Megaport’s global, private Software Defined Network (SDN) platform available to TD SYNNEX customers. “Bringing Megaport’s leading Network as a Service platform into the TD SYNNEX portfolio makes it easier for customers to modernize their network connectivity and connect quickly to leading cloud service providers,” said Rodney Foreman, Chief Revenue Officer at Megaport. “TD SYNNEX’s global scale and reach, combined with their expertise in IT solutions, makes them an ideal partner to expand our channel relationships.” "TD SYNNEX is committed to delivering IT solutions to our customers that unlock their growth," said Cheryl Neal, vice president of New Vendor Acquisition, TD SYNNEX. "Adding Megaport’s Network as a Service offerings to our vast portfolio of IT solutions enables our customers t

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