NEWTON,
Mass., Sept. 26, 2023 /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 to be presented at the 2023
International Myeloma Society (IMS) Annual Meeting, being held
September 27-30 in Athens, Greece. In addition, exploratory
subgroup analyses from the SIENDO Study in patients with advanced
or recurrent TP53 wild-type endometrial cancer will be
presented in an oral session, "Abstract Session: Best Oral Session
– Endometrial Cancer," at the 2023 European Society of
Gynaecological Oncology (ESGO) Congress, being held September 28-October 1 in Istanbul, Turkey.
"We are pleased to have a number of presentations at IMS and
ESGO this year that continue to show the meaningful benefit
achieved with selinexor across a number of tumor types," said
Reshma Rangwala, MD, PhD, Chief
Medical Officer of Karyopharm. "The breadth of data to be presented
further demonstrates our commitment, as well as that of our
collaborators, to develop first-in-class therapies that inhibit
XPO1 with the goal to improve outcomes for patients across solid
and hematological tumors."
Details for the Karyopharm presentations at ESGO are as
follows:
Abstract
Title
|
Presentation
Type
|
Abstract
#
|
Session
Date/Time
|
Endometrial
Cancer
|
Long-term Follow up of
Selinexor
Maintenance for Patients with TP53wt
Advanced or Recurrent Endometrial Cancer: A
Pre-Specified Subgroup Analysis from the
Phase 3 ENGO-EN5/GOG-3055/SIENDO Study
|
Oral
|
264
|
Sunday, October 1,
2023
12:05pm – 12:15 pm
GMT/ 5:05am -5:15am
EST
|
ENGOT-EN20/GOG-3083/XPORT-EC-042 a
Phase 3, Randomized, Placebo-Controlled,
Double-Blind, Multicenter Trial of Selinexor in
Maintenance Therapy for Patients with
TP53wt, Advanced or Recurrent Endometrial
Carcinoma
|
Poster
|
265
|
Saturday, September 30,
2023
15:05-15:50pm
GMT/11:05am – 11:50am
|
Details for the Karyopharm IMS posters are as follows:
Abstract
Title
|
Presentation
Type
|
Abstract
#
|
Session
Date/Time
|
Multiple
Myeloma
|
A Phase 3 Randomized,
Open-label Trial of
Selinexor, Pomalidomide, and Dexamethasone
Versus Elotuzumab, Pomalidomide, and
Dexamethasone in Patients with Relapsed
or Refractory Multiple Myeloma
|
Poster
|
P-323
|
Thursday, September 28,
2023
12:30pm – 1:30pm
EEST/
5:30am -6:30am
EST
|
Effectiveness of
anti-B-cell maturation antigen
(BCMA)-targeting therapy after selinexor
treatment
|
Poster
|
P-232
|
Thursday, September 28,
2023
12:30pm – 1:30pm
EEST/
5:30am -6:30am
EST
|
In addition, Karyopharm will be featured as part of the
following alliance partner and independent investigator posters at
IMS:
Abstract
Title
|
Presentation
Type
|
Abstract
#
|
Session
Date/Time
|
Multiple
Myeloma
|
African American
Relapsed/Refractory
Multiple Myeloma Patients Have a Progression
Free Survival Benefit with Selinexor Treatment
in the STORM Study
|
Poster
|
P-241
|
Thursday, September 28,
2023
12:30pm – 1:30pm
EEST/
5:30am -6:30am
EST
|
Efficacy, Survival and
Safety of Selinexor,
Bortezomib and Dexamethasone (SVD) in
Patients with Lenalidomide-Refractory
Multiple Myeloma: Subgroup Data from the
BOSTON Trial
|
Poster
|
P-295
|
Thursday, September 28,
2023
12:30pm – 1:30pm
EEST/
5:30am -6:30am
EST
|
Selinexor, Bortexomib,
and Dexamethasone in
Patients with Previously Treated Multiple
Myeloma: Updated Results of BOSTON Trial by
Prior Therapies
|
Poster
|
P-297
|
Thursday, September 28,
2023
12:30pm – 1:30pm
EEST/
5:30am -6:30am
EST
|
Investigation of T-cell
Fitness and Mechanisms
of Drug Resistance in Selinexor Treated
Patients with Relapsed/Refractory Multiple
Myeloma
|
Poster
|
P-396
|
Friday, September 29,
2023
1:15pm – 2:15pm
EEST/
6:15am -7:15am
EST
|
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 various indications in a
growing number of ex-U.S. territories and countries, including but
not limited to the European Union, the United Kingdom, China, South
Korea, Canada, Israel and Taiwan. XPOVIO and NEXPOVIO is marketed by
Karyopharm's partners, Antengene, Menarini, Neopharm and FORUS, in
China, South Korea, Singapore, Australia, Hong
Kong, Germany, Austria, Israel and Canada.
Please refer to the local Prescribing Information for full
details.
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
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
pioneering novel cancer therapies. Since its founding, Karyopharm
has been an industry leader in oral Selective Inhibitor of Nuclear
Export (SINE) compound technology, which was developed to address a
fundamental mechanism of oncogenesis: nuclear export dysregulation.
Karyopharm's lead SINE 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
and has 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 multiple high unmet need cancer indications,
including in multiple myeloma, endometrial cancer, myelodysplastic
neoplasms and myelofibrosis. For more information about our people,
science and pipeline, please visit www.karyopharm.com, and follow
us on Twitter at @Karyopharm and LinkedIn.
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 and
myelofibrosis; and expectations related to the clinical development
of selinexor 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 and
eltanexor, 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 studies, including subsequent
analysis of existing data and new data received from ongoing and
future studies; 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 studies; 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 Quarterly Report on Form 10-Q for
the quarter ended June 30, 2023,
which was filed with the Securities and Exchange Commission (SEC)
on August 2, 2023, 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.