Key abstracts to be presented at the meeting will feature clinical data for XPOVIO (selinexor), the Company's first in class, oral Selective Inhibitor of Nuclear Export (SINE) compound, including: (i) multiple new subgroup analyses from the pivotal Phase 3 BOSTON study, including data results evaluating XPOVIO treatment for patients over the age of 65 years old, patients with RAS-mutated multiple myeloma, patients previously treated with Revlimid (lenalidomide), and genomic predictors of efficacy; (ii) updated data from the Kyprolis (carfilzomib) and Pomalyst (pomalidomide) arms of the Phase 1b/2 STOMP study evaluating XPOVIO in combination with standard of care agents in previously treated multiple myeloma; (iii) evaluation of XPOVIO combinations in patients with multiple myeloma following treatment with anti-CD38 monoclonal antibodies; (iv) the effect of lymphocyte count on safety and efficacy in the Phase 2b SADAL study evaluating XPOVIO in patients with diffuse large B-cell lymphoma; and (v) updated overall survival data from a Phase 1/2 study evaluating oral eltanexor, the Company's second generation SINE compound, in patients with hypomethylating-agent refractory myelodysplastic syndrome.
'We are pleased to see such a broad display of data from our clinical programs presented at EHA this year. In particular, we are encouraged that updated data from the Kyprolis arm of the STOMP study was selected for an oral presentation,' said
Abstracts Featuring XPOVIO (selinexor)
Title: Once Weekly Selinexor, Carfilzomib, and Dexamethasone (XKd) in Carfilzomib Nonrefractory Multiple Myeloma (MM) Patients
Presenter:
Abstract #: S188
Date and time:
Session type: Oral Presentation
Session: New diagnostic and therapeutic approaches in multiple myeloma and AL amyloidosis
Title: Oral Selinexor, Pomalidomide, and Dexamethasone (XPd) at Recommended Phase 2 Dose in Relapsed Refractory Multiple Myeloma (MM)
Presenter:
Abstract #: EP-1008
Date and time:
Session type: E-Poster Presentation
Session: Myeloma and other monoclonal gammopathies - Clinical
Title: Selinexor Containing Regimens in Patients with Multiple Myeloma (MM) Previously Treated with anti-CD38 Monoclonal Antibodies
Presenter:
Abstract #: EP1002
Date and time:
Session type: E-Poster Presentation
Session: Myeloma and other monoclonal gammopathies - Clinical
Title: Survival Among Older Patients with Previously Treated Multiple Myeloma Treated with Selinexor, Bortezomib, and Dexamethasone (XVd) in the
Presenter:
Abstract #: EP976
Date and time:
Session type: E-Poster Presentation
Session: Myeloma and other monoclonal gammopathies - Clinical
Title: Effects of Selinexor on Previously Treated Multiple Myeloma (MM) with RAS-mutations
Presenter:
Abstract #: EP966
Date and time:
Session type: E-Poster Presentation
Session: Myeloma and other monoclonal gammopathies - Clinical
Title: Efficacy and Safety of Selinexor, Bortezomib, and Dexamethasone Based on Refractory Status to Lenalidomide in Patients with Previously Treated Multiple Myeloma: A Post-hoc Analysis of the
Presenter:
Abstract #: EP974
Date and time:
Session type: E-Poster Presentation
Session: Myeloma and other monoclonal gammopathies - Clinical
Title: Genomic Correlates of Response to Selinexor in Multiple Myeloma from the
Presenter:
Abstract #: EP936
Date and time:
Session type: E-Poster Presentation
Session: Myeloma and other monoclonal gammopathies -
Title: Lymphocyte Count Effect on Efficacy and Safety of Single Agent
Presenter:
Abstract #: EP530
Date and time:
Session type: E-Poster Presentation
Session: Aggressive Non-Hodgkin lymphoma - Clinical
Abstracts Featuring Eltanexor
Title: Updated Overall Survival of Eltanexor for the Treatment of Patients with Hypomethylating Agent Refractory Myelodysplastic Syndrome
Presenter:
Abstract #: EP924
Date and time:
Session type: E-Poster Presentation
Session: Myelodysplastic syndromes - Clinical
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
Contact:
Tel: +1 (888) 209-9326
Email: medicalinformation@karyopharm.com
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 2 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
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
About Eltanexor (KPT-8602)
Eltanexor (KPT-8602) is a second generation oral SINE compound, which is currently being investigated in clinical trials. Eltanexor functions by binding to and inhibiting the nuclear export protein XPO1 (also called CRM1), leading to the accumulation of tumor suppressor proteins in the cell nucleus. Eltanexor has demonstrated minimal brain penetration in animals, which has been associated with reduced toxicities in preclinical studies while maintaining potent anti-tumor effects.
About
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 expectations and plans relating to XPOVIO for the treatment of patients with relapsed or refractory multiple myeloma or certain other tumors; the expected design of the Company's clinical trials; and the therapeutic potential of and potential clinical development plans for Karyopharm's drug candidates, especially 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 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
XPOVIO(selinexor) is a registered trademark of
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