- New antitumor response data from a range of doses and regimens
unveiled today at Incyte investor event
- These results build upon safety and tolerability data presented
earlier today during a mini-oral presentation at the European
Society of Medical Oncology (ESMO) Congress 2024
- Findings support the initiation of a pivotal trial in ovarian
cancer, expected to begin in 2025; additional plans to evaluate
INCB123667 in combination with other treatments are underway
Incyte (Nasdaq:INCY) today announced new early clinical data for
INCB123667, a highly selective, potential first-in-class CDK2
inhibitor, in patients with advanced solid tumors. The trial
results, presented during a mini-oral presentation at the European
Society of Medical Oncology (ESMO) with new, updated data shared
during the Company’s investor event, highlight the potential of
INCB123667 as a differentiated treatment option for cancers with
increased Cyclin E1 activity, amplification and/or overexpression
in cells predictive of CDK2 dependency.
In the trial, patients with advanced or metastatic solid tumors
(n=205) – including ovarian cancer, endometrial cancer,
gastrointestinal cancer, HR+/HER2- breast cancer and triple
negative breast cancer, among others – received varying doses of
INCB123667 ranging from 50mg to 150mg using once-daily (QD) and
twice-daily (BID) dosing schedules.
New data from the Phase 1b dose expansion portion of the trial
(data cut-off August 26, 2024) presented today during Incyte’s
investor event, demonstrate single-agent antitumor activity, and
decreases in circulating tumor DNA (ctDNA) across a range of doses
and regimens, notably in patients with ovarian cancer and
endometrial cancer whose tumors overexpress Cyclin E1. The trial is
ongoing, and the data will continue to mature.
- Of the 37 evaluable participants with platinum-resistant
ovarian cancer treated at three (3) selected dose levels (50mg BID,
100mg QD and 125mg QD) in the expansion portion of the trial, nine
participants (24.3%) experienced an overall response (OR; 2
complete responses [CR] and 7 partial responses [PRs]). The highest
OR rate of 31.3% (5 responders, including 2 CRs) was found in the
50mg BID cohort (16 evaluable participants). Additionally, a
disease control rate (DCR) of 75.7% (28/37) was achieved in
patients with ovarian cancer.
- In addition, 4 PRs were reported among patients with
endometrial cancer.
“The early-stage clinical activity of INCB123667 represents an
exciting and promising breakthrough for patients with ovarian
cancer. We believe this novel CDK2 inhibitor has the potential to
be a foundational treatment for platinum-resistant ovarian cancer,
offering a new and differentiated treatment for patients who
currently have limited treatment options,” said Pablo Cagnoni M.D.,
President, Head of Research and Development, Incyte. “We look
forward to advancing the development of INCB123667 for the
treatment of patients with ovarian cancer both as a single agent
and in combination.”
The Part 1b data build on results from the dose escalation
portion (Part 1a) of the trial evaluating the safety and
tolerability of INCB123667 presented during a mini-oral
presentation (Mini oral session: Developmental therapeutics) at
ESMO.
Results from the Part 1a dose escalation portion of the trial
(data cut-off July 15, 2024) include:
- INCB123667 demonstrated a manageable safety profile (n=84). The
most common hematologic treatment-related adverse events (TRAEs)
were thrombocytopenia (35%, 13% Grade 3), anemia (30%, 7% Grade 3)
and neutropenia (26%, 8% Grade 3). The most common non-hematologic
TRAEs were nausea (42%), fatigue (23%) and vomiting (17%); all of
which were Grade 1 and 2 except one case of Grade 3 vomiting and
one case of Grade 3 fatigue.
- Strong selective inhibition of CDK2 was observed resulting in
circulating tumor DNA (ctDNA) reduction at all dose levels. During
dose escalation, 39 out of 48 patients who had ctDNA measurements
at cycle 1, day 1 and cycle 2, day 1 showed reductions in
ctDNA.
“Results from this study presented today at ESMO reinforce the
idea that the novel and highly selective CDK2 inhibitor INCB123667
may provide a potential new treatment option for cancers with
increased Cyclin E1 signaling (CCNE1 amplification and Cyclin E1
overexpression), predictive of CDK2 dependency,” said Dr. Matteo
Simonelli, Head of Early-Drug Development in Solid Tumors at IRCCS
Humanitas Research Hospital. “The data speak to the potential of
INCB123667 as an active and selective targeted therapy for
different cancer types, particularly ovarian cancer, and I look
forward to seeing further results in later stages of
development.”
The study is ongoing. Plans are underway to initiate a pivotal
study in ovarian cancer next year and evaluate INCB123667 in
combination with other treatments.
Conference Call and Webcast Information
Incyte will host an in-person analyst and investor event today
from 1:00-2:30 p.m. ET (7:00-8:30 p.m. CEST) to discuss key data
presentations at ESMO including data from the POD1UM-303
Presidential Symposia and its CDK2 inhibitor program. The CDK2 data
will include updated results from a later data cut-off, as well as
the data included in the ESMO accepted abstract and mini-oral
presentation.
To access the conference call, please dial 877-407-8037 for
domestic callers or +1 201-689-8037 for international callers. When
prompted, provide the conference identification number,
13748627.
The conference call will also be webcast live and can be
accessed at investor.incyte.com.
About the Trial (NCT05238922)
This open-label, dose-escalation and dose-expansion Phase 1
study is evaluating the safety, tolerability, pharmacokinetics,
pharmacodynamics and preliminary efficacy of INCB123667 when
administered as monotherapy at the recommended dose for expansion
(RDE[s]) in participants with selected advanced or metastatic solid
tumors. Part 1A (dose escalation) determined the recommended dose
of INCB123667 for expansion and the maximum tolerated dose (MTD).
Part 1B (cohort dose expansion phase) will further explore
antitumor activity of INCB123667 as a monotherapy in six
tumor-specific cohorts at the RDEs defined in Part 1A.
For more information about the study, please visit:
https://clinicaltrials.gov/study/NCT05238922.
About INCB123667
INCB123667 is a novel, potent and selective oral small molecule
inhibitor of CDK2 which has been shown to suppress tumor growth as
monotherapy and in combination with standard of care, in Cyclin E
amplified tumor models. Cyclin E amplification and overexpression
has been reported to be associated with CDK4/6 resistance and poor
clinical outcomes in ovarian, gastric, endometrial and breast
cancers. INCB123667 has the potential to be a highly targeted and
efficacious treatment for advanced solid tumors, including
gynecologic tumors, endometrial, uterine, gastric and triple
negative breast cancer, among others.
About Incyte
A global biopharmaceutical company on a mission to Solve On.,
Incyte follows the science to find solutions for patients with
unmet medical needs. Through the discovery, development and
commercialization of proprietary therapeutics, Incyte has
established a portfolio of first-in-class medicines for patients
and a strong pipeline of products in Oncology and Inflammation
& Autoimmunity. Headquartered in Wilmington, Delaware, Incyte
has operations in North America, Europe and Asia.
For additional information on Incyte, please visit Incyte.com or
follow us on social media: LinkedIn, X, Instagram, Facebook,
YouTube.
Incyte Forward-looking Statements
Except for the historical information set forth herein, the
matters set forth in this press release, including statements
regarding the presentation of data for Incyte’s CDK2 inhibitor
(INCB123667), the potential this CDK2 inhibitor offers for
patients, and expectations regarding ongoing and future clinical
trials contain predictions, estimates, and other forward-looking
statements.
These forward-looking statements are based on our current
expectations and are 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;
determinations made by the FDA and regulatory agencies outside of
the United States; the efficacy or safety of our products; the
acceptance of our products in the marketplace; market competition;
unexpected variations in the demand for our products and the
products of our collaboration partners; the effects of announced or
unexpected price regulation or limitations on reimbursement or
coverage for our products; sales, marketing, manufacturing, and
distribution requirements, including our ability to successfully
commercialize and build commercial infrastructure for newly
approved products and any additional new products that become
approved; and other risks detailed from time to time in our reports
filed with the U.S. Securities and Exchange Commission, including
our annual report on Form 10-K and our quarterly report on Form
10-Q for the quarter ended June 30, 2024. We disclaim any intent or
obligation to update these forward-looking statements.
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Incyte Contacts:
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Investors ir@incyte.com
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