Karyopharm Announces XPOVIO® (Selinexor) Clinical Data to be Presented at the American Society of Hematology 2020 Annual Meeting
Karyopharm Therapeutics (Nasdaq: KPTI) announced the selection of twenty-one abstracts for virtual presentation at the ASH 2020 Annual Meeting, scheduled for December 5-8, 2020. Noteworthy presentations will include updated clinical data for XPOVIO (selinexor) in combination therapies for multiple myeloma and lymphoma. Key studies from the STOMP and BOSTON trials will be highlighted, showcasing encouraging response rates and safety profiles. An investor event will be held to discuss the clinical program and ASH data.
- Twenty-one abstracts selected for ASH 2020, indicating strong clinical research activity.
- Encouraging response rates and safety profiles reported for XPOVIO in combination therapies.
- Oral and poster presentations will include pivotal studies from STOMP and BOSTON trials.
- None.
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 ≥
The most common ARs, excluding laboratory abnormalities, in ≥
In patients with MM, fatal ARs occurred in
In patients with DLBCL, fatal ARs occurred in
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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