NEWTON, Mass., Nov. 4, 2020 /PRNewswire/ -- Karyopharm
Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical
company pioneering novel cancer therapies, today announced that
twenty-one abstracts have been selected for virtual presentation,
including two oral presentations, at the upcoming American Society
of Hematology (ASH) 2020 Annual Meeting taking place December 5-8, 2020. Key abstracts to be presented
at the meeting will feature clinical data for XPOVIO® (selinexor),
the Company's first in class, oral SINE compound, including: (i)
updated data from the Pomalyst® (pomalidomide), Kyprolis®
(carfilzomib) and Revlimid® (lenalidomide) arms of the Phase
1b/2 STOMP study evaluating XPOVIO in
combination with backbone therapies in patients with relapsed or
refractory multiple myeloma; (ii) several new subgroup analyses
from the pivotal Phase 3 BOSTON study evaluating once weekly XPOVIO
in combination with once weekly Velcade® (bortezomib) and
low-dose dexamethasone against standard twice weekly Velcade
in adult patients with multiple myeloma who had received one to
three prior lines of therapy; and (iii) new subgroup analyses from
the Phase 2b SADAL study evaluating
XPOVIO in relapsed or refractory diffuse large B-cell lymphoma
(DLBCL).
"Our tradition of having a strong presence at the ASH annual
meeting continues this year and we are excited to share important
clinical data from a variety of our XPOVIO clinical studies," said
Sharon Shacham, PhD, MBA, Founder,
President and Chief Scientific Officer of Karyopharm. "In total,
twenty-one abstracts have been selected, including an oral
presentation highlighting the all-oral regimen of XPOVIO and
Pomalyst® from the ongoing STOMP study. Additionally, updated data
from two other arms of the STOMP study will also be presented,
including the arm investigating XPOVIO and Kyprolis® as well as the
arm investigating XPOVIO and Revlimid®. In all three arms, the
response rates and safety profile continue to be encouraging. In
addition, we look forward to several poster presentations
describing a variety of subanalyses from the Phase 3 BOSTON study
in important subgroups such as older, frail patients, patients
previously treated with proteasome inhibitors, and patients with
high risk cytogenetics, among others."
Karyopharm plans to host a virtual investor and analyst event to
discuss the Company's pipeline of clinical programs and highlights
from the ASH 2020 data presentations. Details for this event,
including date, time, and log-in information will be announced in
the coming weeks. A live webcast of the presentation will be
accessed under "Events & Presentations" in the Investors
section of the Company's website at
http://investors.karyopharm.com/events-presentations. A replay of
the webcast will be archived on the Company's website for 90 days
following the event.
Details for the ASH 2020 presentations are as
follows:
XPOVIO (selinexor) – Company-Sponsored Studies – Oral
Presentation – Multiple Myeloma
Title: Selinexor in combination with pomalidomide and
dexamethasone (SPd) for treatment of patients with relapsed
refractory multiple myeloma (RRMM).
Presenter: Christine Chen,
Princess Margaret Cancer Centre
Abstract #: 726
Session: 653. Myeloma/Amyloidosis: Therapy, excluding
Transplantation; Novel Approaches for Relapsed/Refractory Myeloma
and Amyloidosis
Date and Time: Monday, December 7,
2020, 1:30 p.m. to 3:00 p.m.
ET
Location: Channel 10 (Virtual Meeting)
XPOVIO (selinexor) – Company-Sponsored Studies – Poster
Presentations – Multiple Myeloma
Title: Selinexor in combination with carfilzomib and
dexamethasone, all once weekly (SKd), for patients with
relapsed/refractory multiple myeloma
Presenter: Cristina
Gasparetto, Duke University
Medical Center
Abstract #: 1366
Session: 653. Myeloma/Amyloidosis: Therapy, excluding
Transplantation: Poster I
Date and Time: Saturday, December 5,
2020, 7:00 a.m. to 3:30 p.m.
ET
Location: Poster Hall (Virtual Meeting)
Title: Selinexor, lenalidomide and dexamethasone (SRd)
for patients with relapsed/refractory and newly diagnosed multiple
myeloma
Presenter: Darrell White,
Dalhousie University
Abstract #: 1393
Session: 653. Myeloma/Amyloidosis: Therapy, excluding
Transplantation: Poster I
Date and Time: Saturday, December 5,
2020, 7:00 a.m. to 3:30 p.m.
ET
Location: Poster Hall (Virtual Meeting)
Title: Effect of prior treatment with proteasome
inhibitors on the efficacy and safety of once-weekly selinexor,
bortezomib, and dexamethasone in comparison with twice weekly
bortezomib and dexamethasone in relapsed or refractory multiple
myeloma: subgroup analysis from the BOSTON study
Presenter: Maria Mateos,
University Hospital of Salamanca
Abstract #: 2297
Session: 653. Myeloma/Amyloidosis: Therapy, excluding
Transplantation: Poster II
Date and Time: Sunday, December 6,
2020, 7:00 a.m. to 3:30 p.m.
ET
Location: Poster Hall (Virtual Meeting)
Title: Impact of prior therapies on the safety and
efficacy of once-weekly selinexor, bortezomib, and dexamethasone
compared with twice-weekly bortezomib and dexamethasone in relapsed
ore refractory multiple myeloma: results from the BOSTON study
Presenter: Maria Mateos,
University Hospital of Salamanca
Abstract #: 3245
Session: 653. Myeloma/Amyloidosis: Therapy, excluding
Transplantation: Poster III
Date and Time: Monday, December 7,
2020, 7:00 a.m. to 3:30 p.m.
ET
Location: Poster Hall (Virtual Meeting)
Title: Once weekly selinexor, bortezomib, and
dexamethasone versus twice weekly bortezomib and dexamethasone in
relapsed ore refractory multiple myeloma: age and frailty subgroup
analyses from the phase 3 BOSTON study
Presenter: Harold Auner,
Imperial College London
Abstract #: 3215
Session: 653. Myeloma/Amyloidosis: Therapy, excluding
Transplantation: Poster III
Date and Time: Monday, December 7,
2020, 7:00 a.m. to 3:30 p.m.
ET
Location: Poster Hall (Virtual Meeting)
Title: Once weekly selinexor, bortezomib, and
dexamethasone (SVd) versus twice weekly bortezomib and
dexamethasone (Vd) in relapsed or refractory multiple myeloma:
high-risk cytogenetic risk planned subgroup analyses from the phase
3 BOSTON study
Presenter: Shambavi Richard, Mount Sanai Hospital
Abstract #: 1385
Session: 653. Myeloma/Amyloidosis: Therapy, excluding
Transplantation: Poster I
Date and Time: Saturday, December 5,
2020, 7:00 a.m. to 3:30 p.m.
ET
Location: Poster Hall (Virtual Meeting)
Title: Peripheral neuropathy symptoms, pain and
functioning in relapsed or refractory MM patients treated with
selinexor, bortezomib, and dexamethasone
Presenter: Larysa Sanchez,
Icahn School of Medicine at Mount Sinai
Abstract #: 3489
Session: 906. Outcomes Research—Malignant Conditions
(Myeloid Disease): Poster III
Date and Time: Monday, December 7,
2020, 7:00 a.m. to 3:30 p.m.
ET
Location: Poster Hall (Virtual Meeting)
XPOVIO (selinexor) – Company-Sponsored – Poster Presentations
– Lymphoma
Title: Effect of age on the efficacy and safety of single
agent oral selinexor in patients with relapsed/refractory diffuse
large B-cell lymphoma (DLBCL): a post-hoc analysis from the SADAL
pivotal study
Presenter: Marie Maerevoet, Institut Jules Bordet
Abstract #: 1201
Session: 626. Aggressive Lymphoma (Diffuse Large B-Cell and
Other Aggressive B-Cell Non-Hodgkin Lymphomas)—Results from
Prospective Clinical Trials: Poster I
Date and Time: Saturday, December 5,
2020, 7:00 a.m. to 3:30 p.m.
ET
Location: Poster Hall (Virtual Meeting)
Title: Selinexor efficacy and safety are independent of
renal function in patients with relapsed/refractory diffuse large
B-cell lymphoma (DLBCL): a post-hoc analysis from the pivotal phase
2b SADAL study
Presenter: Jason Westin, The
University of Texas MD Anderson Cancer
Center
Abstract #: 1384
Session: 653. Myeloma/Amyloidosis: Therapy, excluding
Transplantation: Poster I
Date and Time: Saturday, December 5,
2020, 7:00 a.m. to 3:30 p.m.
ET
Location: Poster Hall (Virtual Meeting)
Title: A six-protein activity signature defines favorable
response to selinexor treatment for patients with diffuse large
B-cell lymphoma (DLBCL)
Presenter: Christopher
Walker, Karyopharm Therapeutics
Abstract #: 2125
Session: 627. Aggressive Lymphoma (Diffuse Large B-Cell and
Other Aggressive B-Cell Non-Hodgkin Lymphomas)—Results from
Retrospective/Observational Studies: Poster II
Date and Time: Sunday, December 6,
2020, 7:00 a.m. to 3:30 p.m.
ET
Location: Poster Hall (Virtual Meeting)
XPOVIO (selinexor) – Investigator-Sponsored – Oral
Presentations – Lymphoma
Title: Inhibiting the Nuclear Exporter XPO1 and the
Antiapoptotic Factor BCL2 Is Synergistic in XPO1 Mutant and
Wildtype Lymphoma
Presenter: Justin Taylor,
University of Miami
Abstract #: 526
Session: 605. Molecular Pharmacology, Drug
Resistance—Lymphoid and Other Diseases: Molecular pharmacology and
drug resistance mechanisms in lymphoproliferative disorders
Date and Time: Monday, December 7,
2020 ; 7:00 a.m. to 8:30
a.m.
Location: Channel 8 (Virtual Meeting)
XPOVIO (selinexor) – Investigator-Sponsored – Poster
Presentations – Lymphoma
Title: Selinexor in combination with R-CHOP for frontline
treatment of non-Hodgkin lymphoma: results of a phase 1b study
Presenter: Erlene Seymour,
Wayne State University
Abstract #: 2109
Session: 626. Aggressive Lymphoma (Diffuse Large B-Cell and
Other Aggressive B-Cell Non-Hodgkin Lymphomas)—Results from
Prospective Clinical Trials: Poster II
Date and Time: Sunday, December 6,
2020, 7:00 a.m. to 3:30 p.m.
ET
Location: Poster Hall (Virtual Meeting)
Title: A Phase I Investigator Sponsored Trial of
Selinexor (KPT-330) and Rituximab, Ifosfamide, Carboplatin and
Etoposide in Patients with Relapsed or Refractory Aggressive B-Cell
Lymphomas
Presenter: Sarah Rutherford,
Weill Cornell Medicine
Abstract #: 2104
Session: 626. Aggressive Lymphoma (Diffuse Large B-Cell and
Other Aggressive B-Cell Non-Hodgkin Lymphomas)—Results from
Prospective Clinical Trials: Poster II
Date and Time: Sunday,
December 6, 2020, 7:00 a.m. to 3:30
p.m. ET
Location: Poster Hall (Virtual Meeting)
Title: XPO1 Relieves MYC-Induced Replication Stress
Limiting the Immunogenicity of DLBCL Cells
Presenter: Rossella Marullo,
Weill Cornell Medicine
Abstract #: 2018
Session: 621. Lymphoma—Genetic/Epigenetic Biology: Poster
II
Date and Time: Sunday,
December 6, 2020, 7:00 a.m. to 3:30
p.m. ET
Location: Poster Hall (Virtual Meeting)
Title: The Expression of Chromosome Region Maintenance
Protein 1 (CRM1) in Large Cell Lymphoma
Presenter: Jithma Abeykoon, Mayo Clinic
Abstract #: 2132
Session: 627. Aggressive Lymphoma (Diffuse Large B-Cell and
Other Aggressive B-Cell Non-Hodgkin Lymphomas)—Results from
Retrospective/Observational Studies: Poster II
Date and Time: Sunday,
December 6, 2020, 7:00 a.m. to 3:30
p.m. ET
Location: Poster Hall (Virtual Meeting)
XPOVIO (selinexor) – Investigator-Sponsored – Poster
Presentations – Leukemia
Title: Frontline selinexor and chemotherapy is highly
active in older adults with AML
Presenter: Timothy Pardee,
Wake Forest School of Medicine
Abstract #: 633
Session: 615. Acute Myeloid Leukemia: Commercially Available
Therapy, excluding Transplantation: Commercially Available Therapy,
excluding Transplantation II
Date and Time: Monday, December 7,
2020, 11:45 a.m. ET
Location: Channel 12 (Virtual Meeting)
Title: Exportin-1 (XPO1) Inhibition Sequesters p53 from
MDM2 and MDM4 and Is Highly Synergistic with MDM2 Inhibition in
Inducing Apoptosis in Wild-Type p53 Acute Myeloid Leukemias
Presenter: Yuki Nishida, MD
Anderson Cancer Center
Abstract #: 2775
Session: 603. Oncogenes and Tumor Suppressors: Poster
III
Date and Time: Monday, December 7,
2020, 7:00 a.m. to 3:30 p.m.
ET
Location: Poster Hall (Virtual Meeting)
XPOVIO (selinexor) – Investigator-Sponsored – Poster
Presentations – Other
Title: CRISPR/Cas9 Chemogenetic Profiling Identifies
Candidate Biomarker Genes That Modulate Sensitivity to
Selinexor
Presenter: Bert Kwanten, KU Leuven
Abstract #: 965
Session: 604. Molecular Pharmacology and Drug Resistance in
Myeloid Diseases: Poster I
Date and Time: Saturday, December 5,
2020, 7:00 a.m. to 3:30 p.m.
ET
Location: Poster Hall (Virtual Meeting)
Title: Salicylates Potentiate and Broaden CRM1 Inhibitor
Anti-Tumor Activity Via S-Phase Arrest and Impaired DNA-Damage
Repair
Presenter: Jithma Abeykoon, Mayo Clinic
Abstract #: 171
Session: 625. Lymphoma: Pre-Clinical—Chemotherapy and
Biologic Agents: Novel Approaches to Overcome Resistance
Date and Time: Saturday, December 5,
2020, 12:00 p.m. ET
Location: Channel 7 (Virtual Meeting)
KPT-9274 – Investigator-Sponsored – Poster Presentations –
Other
Title: Nicotinamide Phosphoribosyltransferase Inhibitors
Induce Apoptosis of AML Stem Cells through Dysregulation of Lipid
Metabolism
Presenter: Amit Subedi,
Princess Margaret Cancer Center
Abstract #: 2777
Session: 604. Molecular Pharmacology and Drug Resistance in
Myeloid Diseases: Poster III
Date and Time: Monday, December 7,
2020, 7:00 a.m. to 3:30 p.m.
ET
Location: Poster Hall (Virtual Meeting)
About XPOVIO® (selinexor)
XPOVIO is a first-in-class,
oral Selective Inhibitor of Nuclear Export (SINE) compound. XPOVIO
functions by selectively binding to and inhibiting the nuclear
export protein exportin 1 (XPO1, also called CRM1). XPOVIO blocks
the nuclear export of tumor suppressor, growth regulatory and
anti-inflammatory proteins, leading to accumulation of these
proteins in the nucleus and enhancing their anti-cancer activity in
the cell. The forced nuclear retention of these proteins can
counteract a multitude of the oncogenic pathways that, unchecked,
allow cancer cells with severe DNA damage to continue to grow and
divide in an unrestrained fashion. Karyopharm received accelerated
U.S. Food and Drug Administration (FDA) approval of XPOVIO in
July 2019 in combination with
dexamethasone for the treatment of adult patients with relapsed
refractory multiple myeloma (RRMM) 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. Karyopharm has also submitted a
Marketing Authorization Application (MAA) to the European Medicines
Agency (EMA) with a request for conditional approval of selinexor
in this same RRMM indication. Karyopharm's supplemental New Drug
Application (sNDA) requesting an expansion of its current
indication to include the treatment for patients with multiple
myeloma after at least one prior line of therapy has been accepted
for filing by the FDA. In June 2020,
Karyopharm received accelerated FDA approval of XPOVIO for its
second indication in adult patients with relapsed or refractory
diffuse large B-cell lymphoma (DLBCL), not otherwise specified,
including DLBCL arising from follicular lymphoma, after at least 2
lines of systemic therapy. Selinexor is also being evaluated in
several other mid-and later-phase clinical trials across multiple
cancer indications, including as a potential backbone therapy in
combination with approved myeloma therapies (STOMP), in liposarcoma
(SEAL) and in endometrial cancer (SIENDO), among others. Additional
Phase 1, Phase 2 and Phase 3 studies are ongoing or currently
planned, including multiple studies in combination with approved
therapies in a variety of tumor types to further inform
Karyopharm's clinical development priorities for selinexor.
Additional clinical trial information for selinexor is available at
www.clinicaltrials.gov.
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
IMPORTANT SAFETY INFORMATION
Thrombocytopenia: XPOVIO can cause life-threatening
thrombocytopenia, potentially leading to hemorrhage.
Thrombocytopenia was reported in patients with multiple myeloma
(MM) and developed or worsened in patients with DLBCL.
Thrombocytopenia is the leading cause of dosage modifications.
Monitor platelet counts at baseline and throughout treatment.
Monitor more frequently during the first 3 months of treatment.
Institute platelet transfusion and/or other treatments as
clinically indicated. Monitor patients for signs and symptoms of
bleeding and evaluate promptly. Interrupt, reduce dose, or
permanently discontinue based on severity of adverse reaction.
Neutropenia: XPOVIO can cause life-threatening
neutropenia, potentially increasing the risk of infection.
Neutropenia and febrile neutropenia occurred in patients with MM
and in patients with DLBCL.
Obtain white blood cell counts with differential at baseline and
throughout treatment. Monitor more frequently during the first 3
months of treatment. Monitor patients for signs and symptoms of
concomitant infection and evaluate promptly. Consider supportive
measures, including antimicrobials and growth factors (e.g.,
G-CSF). Interrupt, reduce dose, or permanently discontinue based on
severity of adverse reaction (AR).
Gastrointestinal Toxicity: XPOVIO can cause severe
gastrointestinal toxicities in patients with MM and DLBCL.
Nausea/Vomiting: Provide prophylactic antiemetics.
Administer 5-HT3 receptor antagonists and other anti-nausea agents
prior to and during treatment with XPOVIO. Interrupt, reduce dose,
or permanently discontinue based on severity of ARs. Administer
intravenous fluids to prevent dehydration and replace electrolytes
as clinically indicated.
Diarrhea: Interrupt, reduce dose, or permanently
discontinue based on severity of ARs. Provide standard
anti-diarrheal agents, administer intravenous fluids to prevent
dehydration, and replace electrolytes as clinically indicated.
Anorexia/Weight Loss: Monitor weight, nutritional
status, and volume status at baseline and throughout treatment.
Monitor more frequently during the first 3 months of treatment.
Interrupt, reduce dose, or permanently discontinue based on
severity of ARs. Provide nutritional support, fluids, and
electrolyte repletion as clinically indicated.
Hyponatremia: XPOVIO can cause severe or
life-threatening hyponatremia. Hyponatremia developed in patients
with MM and in patients with DLBCL.
Monitor sodium level at baseline and throughout treatment.
Monitor more frequently during the first 2 months of treatment.
Correct sodium levels for concurrent hyperglycemia (serum glucose
>150 mg/dL) and high serum paraprotein levels. Assess hydration
status and manage hyponatremia per clinical guidelines, including
intravenous saline and/or salt tablets as appropriate and dietary
review. Interrupt, reduce dose, or permanently discontinue based on
severity of the AR.
Serious Infection: XPOVIO can cause
serious and fatal infections. Most infections were not associated
with Grade 3 or higher neutropenia. Atypical infections reported
after taking XPOVIO include, but are not limited to, fungal
pneumonia and herpesvirus infection.
Monitor for signs and symptoms of infection, and evaluate and
treat promptly.
Neurological Toxicity: XPOVIO can cause
life-threatening neurological toxicities.
Coadministration of XPOVIO with other products that cause
dizziness or mental status changes may increase the risk of
neurological toxicity.
Advise patients to refrain from driving and engaging in
hazardous occupations or activities, such as operating heavy or
potentially dangerous machinery, until the neurological toxicity
fully resolves. Optimize hydration status, hemoglobin level, and
concomitant medications to avoid exacerbating dizziness or mental
status changes. Institute fall precautions as appropriate.
Embryo-Fetal Toxicity: XPOVIO can cause fetal harm
when administered to a pregnant woman.
Advise pregnant women of the potential risk to a fetus. Advise
females of reproductive potential and males with a female partner
of reproductive potential to use effective contraception during
treatment with XPOVIO and for 1 week after the last dose.
ADVERSE REACTIONS
The most common adverse reactions (ARs) in ≥20% of patients with
MM are thrombocytopenia, fatigue, nausea, anemia, decreased
appetite, decreased weight, diarrhea, vomiting, hyponatremia,
neutropenia, leukopenia, constipation, dyspnea, and upper
respiratory tract infection.
The most common ARs, excluding laboratory abnormalities, in ≥20%
of patients with DLBCL are fatigue, nausea, diarrhea, appetite
decrease, weight decrease, constipation, vomiting, and pyrexia.
Grade 3-4 laboratory abnormalities in ≥15% of patients included
thrombocytopenia, lymphopenia, neutropenia, anemia, and
hyponatremia. Grade 4 laboratory abnormalities in ≥5% were
thrombocytopenia, lymphopenia, and neutropenia.
In patients with MM, fatal ARs occurred in 9% of patients.
Serious ARs occurred in 58% of patients. Treatment discontinuation
rate due to ARs was 27%. The most frequent ARs requiring permanent
discontinuation in ≥4% of patients included fatigue, nausea, and
thrombocytopenia.
In patients with DLBCL, fatal ARs occurred in 3.7% of patients
within 30 days, and 5% of patients within 60 days of last
treatment; the most frequent fatal AR was infection (4.5% of
patients). Serious ARs occurred in 46% of patients; the most
frequent serious AR was infection. Discontinuation due to ARs
occurred in 17% of patients.
USE IN SPECIFIC POPULATIONS
In MM, no overall difference in effectiveness of XPOVIO was
observed in patients >65 years old when compared with younger
patients. Patients ≥75 years old had a higher incidence of
discontinuation due to an AR than younger patients, a higher
incidence of serious ARs, and a higher incidence of fatal ARs.
Clinical studies in patients with relapsed or refractory DLBCL
did not include sufficient numbers of patients aged 65 and over to
determine whether they respond differently from younger
patients.
The effect of end-stage renal disease
(CLCR <15 mL/min) or hemodialysis on XPOVIO
pharmacokinetics is unknown.
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.
Please see XPOVIO Full Prescribing Information available at
www.XPOVIO.com.
About Karyopharm Therapeutics
Karyopharm Therapeutics Inc. (Nasdaq: KPTI) is a
commercial-stage pharmaceutical company pioneering novel cancer
therapies and dedicated to the discovery, development, and
commercialization of novel first-in-class drugs directed against
nuclear export and related targets for the treatment of cancer and
other major diseases. Karyopharm's Selective Inhibitor of Nuclear
Export (SINE) compounds function by binding with and inhibiting the
nuclear export protein XPO1 (or CRM1). Karyopharm's lead compound,
XPOVIO® (selinexor), received accelerated approval from the U.S.
Food and Drug Administration (FDA) in July
2019 in combination with dexamethasone as a treatment for
patients with heavily pretreated multiple myeloma. In June 2020, XPOVIO was approved by the FDA as a
treatment for patients with relapsed or refractory diffuse large
B-cell lymphoma. A Marketing Authorization Application for
selinexor for patients with heavily pretreated multiple myeloma is
also currently under review by the European Medicines Agency. In
addition to single-agent and combination activity against a variety
of human cancers, SINE compounds have also shown biological
activity in models of neurodegeneration, inflammation, autoimmune
disease, certain viruses and wound-healing. Karyopharm has several
investigational programs in clinical or preclinical development.
For more information, please visit
www.karyopharm.com.
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 beliefs regarding the ability of selinexor to treat
patients with multiple myeloma, diffuse large B-cell lymphoma,
solid tumors and other diseases and expectations related to future
clinical development and potential regulatory submissions of
XPOVIO. 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; that regulators will agree that selinexor
qualifies for conditional approval in the E.U. as a result of data
from the STORM study or confirmatory approval in the U.S. or EU
based on the BOSTON study in
patients with relapsed or refractory multiple myeloma; 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 risk that the COVID-19 pandemic could disrupt
Karyopharm's business more severely than it currently anticipates,
including by negatively impacting sales of XPOVIO, interrupting or
delaying research and development efforts, impacting the ability to
procure sufficient supply for the development and commercialization
of selinexor or other product candidates, delaying ongoing or
planned clinical trials, impeding the execution of business plans,
planned regulatory milestones and timelines, or inconveniencing
patients; 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 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 obtain and
maintain requisite regulatory approvals and to enroll patients in
its clinical trials; unplanned cash requirements and expenditures;
development of drug candidates by Karyopharm's competitors for
diseases in which Karyopharm is currently developing its drug
candidates; and Karyopharm's ability to obtain, maintain and
enforce patent and other intellectual property protection for any
drug candidates it is developing. 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, 2020, which was filed with the
Securities and Exchange Commission (SEC) on November 2, 2020, 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.
Velcade® is a registered trademark of Takeda Pharmaceutical
Company Limited
Revlimid® and Pomalyst® are registered trademarks of Celgene
Corporation
Kyprolis® is a registered trademark of Onyx Pharmaceuticals,
Inc.
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