Invited to Present Updated Endometrial Cancer
Data During Special Session "ASCO Plenary Series: Rapid Abstract
Updates"
NEWTON,
Mass., April 24, 2024 /PRNewswire/ -- Karyopharm
Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical
company pioneering novel cancer therapies, today announced that
several abstracts detailing new selinexor data have been selected
for presentation at the 2024 American Society of Clinical Oncology
Annual Meeting (2024 ASCO Annual Meeting) being held
May 31 - June 4 in Chicago, IL. The Company is pleased to have
received an invitation to present updated Endometrial Cancer data
during a special session called "ASCO Plenary Series: Rapid
Abstract Updates."
A highlight at the 2024 ASCO Annual Meeting includes a rapid
oral abstract update of long-term follow-up of selinexor
maintenance in patients with TP53wt advanced or recurrent
endometrial cancer – a pre-specified subgroup analysis from the
Phase 3 ENGOT-EN5/GOG-3055/SIENDO Study.
"As we follow the endometrial cancer patients
whose tumors are TP53wt and evaluate the long-term benefit,
our confidence for selinexor to provide meaningful benefit for
patients continues to grow," said Reshma
Rangwala, MD, PhD, Chief Medical Officer of Karyopharm. "We
are excited about the advancement of our three, phase three
programs in areas of high unmet need in endometrial cancer,
myelofibrosis, and multiple myeloma."
Details for the 2024 ASCO Annual Meeting abstracts are as
follows:
Abstract
Title
|
Presentation
Type
|
Abstract
#
|
Session
Date/Time
|
Endometrial
Cancer
|
Updates on Abstract
427956: Long-Term
Follow up of Selinexor Maintenance in
Patients with TP53wt Advanced or
Recurrent Endometrial Cancer—A Pre-
Specified Subgroup Analysis from the
Phase 3 ENGOT-EN5/GOG-3055/SIENDO Study (Rapid abstract update presentation
following July 25, 2023 Plenary Series)
|
Rapid Oral
|
427956
|
June 1, 2024
12:30pm-1:30pm
CDT
|
Phase 3 Dose Selection
for Selinexor in
TP53wt Endometrial Cancer Based on
Exposure-Response Analysis
|
Poster
|
5594
|
June 3, 2024
9:00am – 12:00pm
CDT
|
Myelofibrosis
|
Phase 3 Trial Design:
Randomized
Double-Blind Study Evaluating Selinexor,
an XPO1 inhibitor, Plus Ruxolitinib in Jaki-
Naïve Myelofibrosis
|
Poster
|
TPS6594
|
June 3, 2024
9:00am – 12:00pm
CDT
|
Phase 2 Study Trial
Design: Evaluating
Selinexor Monotherapy in Patients with
Jaki-Naïve Myelofibrosis and Moderate
Thrombocytopenia
|
Poster
|
TPS6593
|
June 3, 2024
9:00am – 12:00pm
CDT
|
About XPOVIO® (selinexor)
XPOVIO is a first-in-class,
oral exportin 1 (XPO1) inhibitor and the first of Karyopharm's
Selective Inhibitor of Nuclear Export (SINE) compounds to be
approved for the treatment of cancer. XPOVIO functions by
selectively binding to and inhibiting the nuclear export protein
XPO1. XPOVIO is approved in the U.S. and marketed by Karyopharm in
multiple oncology indications, including: (i) in combination with
Velcade® (bortezomib) and dexamethasone (XVd) in patients with
multiple myeloma after at least one prior therapy; (ii) in
combination with dexamethasone in patients with heavily pre-treated
multiple myeloma; and (iii) in patients with diffuse large B-cell
lymphoma (DLBCL), including DLBCL arising from follicular lymphoma,
after at least two lines of systemic therapy. XPOVIO (also known as
NEXPOVIO® in certain countries) has received regulatory approvals
in a growing number of ex-U.S. territories and countries,
including Europe, the United Kingdom, South
Korea, Israel, Singapore, Hong Kong, Mainland
China, Australia, Canada, Taiwan and Macau and
is marketed in those areas by Karyopharm's global partners.
Selinexor is also being investigated in several other mid- and
late-stage clinical trials across multiple high unmet need cancer
indications, including in endometrial cancer and myelofibrosis.
For more information about Karyopharm's products or clinical
trials, please contact the Medical Information department at:
Tel: +1 (888) 209-9326,
Email: medicalinformation@karyopharm.com
XPOVIO® (selinexor) is a prescription medicine
approved:
- In combination with bortezomib and dexamethasone for the
treatment of adult patients with multiple myeloma who have received
at least one prior therapy (XVd).
- In combination with dexamethasone for the treatment of adult
patients with relapsed or refractory multiple myeloma who have
received at least four prior therapies and whose disease is
refractory to at least two proteasome inhibitors, at least two
immunomodulatory agents, and an anti‐CD38 monoclonal antibody
(Xd).
- For the treatment of adult patients with relapsed or refractory
diffuse large B‐cell lymphoma (DLBCL), not otherwise specified,
including DLBCL arising from follicular lymphoma, after at least
two lines of systemic therapy. This indication is approved under
accelerated approval based on response rate. Continued approval for
this indication may be contingent upon verification and description
of clinical benefit in confirmatory trial(s).
SELECT IMPORTANT SAFETY INFORMATION
Warnings and Precautions
- Thrombocytopenia: Monitor platelet counts throughout treatment.
Manage with dose interruption and/or reduction and supportive
care.
- Neutropenia: Monitor neutrophil counts throughout treatment.
Manage with dose interruption and/or reduction and granulocyte
colony‐stimulating factors.
- Gastrointestinal Toxicity: Nausea, vomiting, diarrhea,
anorexia, and weight loss may occur. Provide antiemetic
prophylaxis. Manage with dose interruption and/or reduction,
antiemetics, and supportive care.
- Hyponatremia: Monitor serum sodium levels throughout treatment.
Correct for concurrent hyperglycemia and high serum paraprotein
levels. Manage with dose interruption, reduction, or
discontinuation, and supportive care.
- Serious Infection: Monitor for infection and treat
promptly.
- Neurological Toxicity: Advise patients to refrain from driving
and engaging in hazardous occupations or activities until
neurological toxicity resolves. Optimize hydration status and
concomitant medications to avoid dizziness or mental status
changes.
- Embryo‐Fetal Toxicity: Can cause fetal harm. Advise females of
reproductive potential and males with a female partner of
reproductive potential, of the potential risk to a fetus and use of
effective contraception.
- Cataract: Cataracts may develop or progress. Treatment of
cataracts usually requires surgical removal of the cataract.
Adverse Reactions
- The most common adverse reactions (≥20%) in patients with
multiple myeloma who receive XVd are fatigue, nausea, decreased
appetite, diarrhea, peripheral neuropathy, upper respiratory tract
infection, decreased weight, cataract and vomiting. Grade 3‐4
laboratory abnormalities (≥10%) are thrombocytopenia, lymphopenia,
hypophosphatemia, anemia, hyponatremia and neutropenia. In the
BOSTON trial, fatal adverse
reactions occurred in 6% of patients within 30 days of last
treatment. Serious adverse reactions occurred in 52% of patients.
Treatment discontinuation rate due to adverse reactions was
19%.
- The most common adverse reactions (≥20%) in patients with
multiple myeloma who receive Xd are thrombocytopenia, fatigue,
nausea, anemia, decreased appetite, decreased weight, diarrhea,
vomiting, hyponatremia, neutropenia, leukopenia, constipation,
dyspnea and upper respiratory tract infection. In the STORM trial,
fatal adverse reactions occurred in 9% of patients. Serious adverse
reactions occurred in 58% of patients. Treatment discontinuation
rate due to adverse reactions was 27%.
- The most common adverse reactions (incidence ≥20%) in patients
with DLBCL, excluding laboratory abnormalities, are fatigue,
nausea, diarrhea, appetite decrease, weight decrease, constipation,
vomiting, and pyrexia. Grade 3‐4 laboratory abnormalities (≥15%)
are thrombocytopenia, lymphopenia, neutropenia, anemia, and
hyponatremia. In the SADAL trial, fatal adverse reactions occurred
in 3.7% of patients within 30 days, and 5% of patients within 60
days of last treatment; the most frequent fatal adverse reactions
was infection (4.5% of patients). Serious adverse reactions
occurred in 46% of patients; the most frequent serious adverse
reaction was infection (21% of patients). Discontinuation due to
adverse reactions occurred in 17% of patients.
Use In Specific Populations
Lactation: Advise not to
breastfeed.
For additional product information, including full prescribing
information,
please visit www.XPOVIO.com.
To report SUSPECTED ADVERSE REACTIONS, contact Karyopharm
Therapeutics Inc. at 1‐888‐209‐9326 or FDA at 1‐800‐FDA‐1088 or
www.fda.gov/medwatch.
About Karyopharm Therapeutics
Karyopharm Therapeutics Inc. (Nasdaq: KPTI) is a
commercial-stage pharmaceutical company whose dedication to
pioneering novel cancer therapies is fueled by a belief in the
extraordinary strength and courage of patients with cancer. Since
its founding, Karyopharm has been an industry leader in oral
compounds that address nuclear export dysregulation, a fundamental
mechanism of oncogenesis. Karyopharm's lead compound and
first-in-class, oral exportin 1 (XPO1) inhibitor, XPOVIO®
(selinexor), is approved in the U.S. and marketed by the Company in
three oncology indications. It has also received regulatory
approvals in various indications in a growing number of ex-U.S.
territories and countries, including Europe and the United Kingdom (as NEXPOVIO®) and China. Karyopharm has a focused pipeline
targeting indications in multiple high unmet need cancers,
including in multiple myeloma, endometrial cancer, myelofibrosis,
and diffuse large B-cell lymphoma (DLBCL). For more information
about our people, science and pipeline, please visit
www.karyopharm.com, and follow us on LinkedIn and on X at
@Karyopharm.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of The Private Securities Litigation Reform Act of
1995. Such forward-looking statements include those regarding the
ability of selinexor to treat patients with multiple myeloma,
endometrial cancer, myelofibrosis, diffuse large B-cell lymphoma,
and other diseases; and expectations with respect to the clinical
development plans and potential regulatory submissions of
selinexor. Such statements are subject to numerous important
factors, risks and uncertainties, many of which are beyond
Karyopharm's control, that may cause actual events or results to
differ materially from Karyopharm's current expectations. For
example, there can be no guarantee that Karyopharm will
successfully commercialize XPOVIO or that any of Karyopharm's drug
candidates, including selinexor, will successfully complete
necessary clinical development phases or that development of any of
Karyopharm's drug candidates will continue. Further, there can be
no guarantee that any positive developments in the development or
commercialization of Karyopharm's drug candidate portfolio will
result in stock price appreciation. Management's expectations and,
therefore, any forward-looking statements in this press release
could also be affected by risks and uncertainties relating to a
number of other factors, including the following: the adoption of
XPOVIO in the commercial marketplace, the timing and costs involved
in commercializing XPOVIO or any of Karyopharm's drug candidates
that receive regulatory approval; the ability to obtain and retain
regulatory approval of XPOVIO or any of Karyopharm's drug
candidates that receive regulatory approval; Karyopharm's results
of clinical trials and preclinical trials, including subsequent
analysis of existing data and new data received from ongoing and
future trials; the content and timing of decisions made by the U.S.
Food and Drug Administration and other regulatory authorities,
investigational review boards at clinical trial sites and
publication review bodies, including with respect to the need for
additional clinical trials; the ability of Karyopharm or its third
party collaborators or successors in interest to fully perform
their respective obligations under the applicable agreement and the
potential future financial implications of such agreement;
Karyopharm's ability to enroll patients in its clinical trials;
unplanned cash requirements and expenditures; development or
regulatory approval of drug candidates by Karyopharm's competitors
for products or product candidates in which Karyopharm is currently
commercializing or developing; the direct or indirect impact of the
COVID-19 pandemic or any future pandemic on Karyopharm's business,
results of operations and financial condition; and Karyopharm's
ability to obtain, maintain and enforce patent and other
intellectual property protection for any of its products or product
candidates. These and other risks are described under the caption
"Risk Factors" in Karyopharm's Annual Report on Form 10-K for the
year ended December 31, 2023, which
was filed with the Securities and Exchange Commission (SEC) on
February 29, 2024, and in other
filings that Karyopharm may make with the SEC in the future. Any
forward-looking statements contained in this press release speak
only as of the date hereof, and, except as required by law,
Karyopharm expressly disclaims any obligation to update any
forward-looking statements, whether as a result of new information,
future events or otherwise.
XPOVIO® and NEXPOVIO® are registered trademarks of Karyopharm
Therapeutics Inc. Any other trademarks referred to in this release
are the property of their respective owners.
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SOURCE Karyopharm Therapeutics Inc.