- 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)
- Investor conference call and webcast scheduled for today,
December 7, at 10:00 a.m. ET (7:00 a.m. PT)
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.
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Incyte Contacts Media
Catalina Loveman +1 302 498 6171 cloveman@incyte.com Nupur Patel,
PharmD +1 302 498 5822 npatel@incyte.com Investors Michael
Booth, DPhil +1 302 498 5914 mbooth@incyte.com Christine Chiou +1
302 274 4773 cchiou@incyte.com
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