NEWTON,
Mass., Dec. 3, 2024 /PRNewswire/
-- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a
commercial-stage pharmaceutical company pioneering novel cancer
therapies, today announced that it is in discussions and has an
upcoming meeting with the U.S. Food and Drug Administration (FDA)
regarding the evolving treatment landscape in endometrial cancer
and any implications this may have with respect to the Company's
Phase 3 XPORT-EC-042 trial. In light of this, Karyopharm does not
plan to discuss its endometrial cancer program during the Piper
Sandler 36th Annual Healthcare Conference being
held in New York, NY today. The
Company intends to provide an update on its endometrial cancer
program as soon as practical following the discussion with FDA.
A live webcast of the fireside chat at the Piper Sandler
36th Annual Healthcare Conference at 11:30 a.m. ET today can be accessed under "Events
& Presentations" in the Investor section of the Company's
website, https://investors.karyopharm.com/events-presentations,
and will be available for replay following the event.
About the EC-042 Study
EC-042 (XPORT-EC-042; NCT05611931) is a global, Phase 3,
randomized, double-blind study evaluating selinexor as a
maintenance therapy following systemic therapy in patients
with TP53 wild-type advanced or recurrent
endometrial cancer. The EC-042 study was initiated in November
2022 and is expected to enroll up to 220 patients who will be
randomized 1:1 to receive either a 60 mg, once-weekly,
administration of oral selinexor or placebo until disease
progression. The primary endpoint of the study is progression free
survival, as assessed by an investigator, with overall survival as
a key secondary endpoint. Further, in connection with the EC-042
Study, Karyopharm entered into a global collaboration with
Foundation Medicine, Inc. to develop FoundationOne®CDx,
a tissue-based comprehensive genomic profiling test to identify and
enroll patients whose tumors
are TP53 wild-type.
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 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) under accelerated approval 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, Mainland China, Taiwan, Hong
Kong, Australia,
South Korea, Singapore, Israel, and Canada. XPOVIO®/NEXPOVIO® is marketed in these
respective ex-U.S. territories by Karyopharm's partners: Antengene,
Menarini, Neopharm, and FORUS. 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 Karyopharm's clinical
development plans and potential regulatory submissions of selinexor
and the ability of selinexor to treat patients with multiple
myeloma, endometrial cancer, myelofibrosis, diffuse large B-cell
lymphoma, and other diseases. 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; substantial doubt exists regarding Karyopharm's
ability to continue as a going concern; 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 September 30, 2024,
which was filed with the Securities and Exchange Commission (SEC)
on November 5, 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.
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SOURCE Karyopharm Therapeutics Inc.