Based on preliminary unaudited financial information, Karyopharm expects net product revenues of XPOVIO to be approximately
'For 2022, we are focused on making significant advances across our pipeline, beginning with top-line results from the Phase 3 SIENDO study evaluating selinexor as a maintenance therapy following front-line chemotherapy in patients with advanced or metastatic endometrial cancer, which remain on track to be reported this quarter,' said
Key Program Achievements in 2021
Selinexor in Multiple Myeloma
Launched XPOVIO in the
Generated compelling clinical data supporting selinexor's efficacy, durability and tolerability when combined with the approved agents Velcade (bortezomib), Pomalyst (pomalidomide) or Kyprolis (carfilzomib) in patients who have been previously exposed to anti-CD38 monoclonal antibody treatment, where there is a substantial unmet need for a new class of therapy. These results were reported at the
Multiple XPOVIO-based regimens are listed on the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines) for the treatment of second and later line multiple myeloma, including selinexor, pomalidomide and dexamethasone (SPd), which is an all-oral regimen, selinexor, daratumumab and dexamethasone (SDd), and selinexor, carfilzomib and dexamethasone (SKd).
The
Karyopharm's Marketing Authorization Application (MAA) for NEXPOVIO in combination with Velcade (bortezomib) and low-dose dexamethasone for the treatment of multiple myeloma following at least one prior therapy has been validated by the
Karyopharm's global partners
Earned
Selinexor in Endometrial Cancer
Completed recruitment in the Phase 3 SIENDO study evaluating the efficacy and safety for front-line maintenance therapy with selinexor in patients with advanced or recurrent endometrial cancer.
Eltanexor in Myelodysplastic Syndromes (MDS)
Reported positive data from an investigator-sponsored Phase 1 study evaluating single-agent eltanexor in patients with hypomethylating agent (HMA)-refractory MDS, where eltanexor demonstrated a 53% overall response rate and median overall survival of 9.9 months. This compares favorably to historical survival of four to six months for HMA-refractory MDS patients.
Commenced dosing in a company-sponsored Phase 2 study evaluating single-agent eltanexor in patients with intermediate or high-risk HMA-refractory MDS.
Selinexor in Myelofibrosis (MF)
Reported positive data from an investigator-sponsored Phase 2 study evaluating single-agent selinexor in patients with MF previously treated with JAK inhibition. In this study, 40% of patients who received at least 24 weeks of selinexor treatment achieved a response, defined as ?35% spleen volume reduction. Responses were durable with a median treatment duration of 11 months.
Commenced dosing in a company-sponsored Phase 2 study evaluating single-agent selinexor versus physician's choice in patients with MF previously treated with a JAK 1/2 inhibitor.
Commenced dosing in a company-sponsored Phase 1/2 study evaluating selinexor in combination with Jakafi (ruxolitinib) in patients with treatment-naive MF.
Corporate and Financial Highlights
Entered into an exclusive license agreement with
Received
Anticipated 2022 Catalysts and Operational Objectives
Leverage commercial capabilities and increase
Report top-line data from Phase 3 SIENDO study evaluating selinexor as a maintenance therapy in endometrial cancer in 1Q 2022.
If SIENDO data are positive, submit supplemental New Drug Application for selinexor in endometrial cancer to the
Dose first patient in Phase 3 study evaluating selinexor, pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma in 1Q 2022.
EMA decision expected in second-line multiple myeloma based on
Realize further milestones and royalties from approvals and sales in ex-US territories in 2022.
The financial information presented in this press release may be adjusted as a result of the completion of customary quarterly and annual review and audit procedures.
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These achievements and updates will be discussed during a webcast presentation at the 40th Annual
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
Contact:
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 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.
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 preliminary financial information for fourth quarter and full year 2021; the ability of selinexor or eltanexor 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 selinexor or eltanexor. 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 grant confirmatory approval in the
XPOVIO and NEXPOVIO are registered trademarks of
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