On May 23, 2023 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported that several abstracts detailing new selinexor data have been selected to be presented at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held June 2-6 in Chicago, Illinois and the 2023 European Hematology Association (EHA) (Free EHA Whitepaper) Hybrid Congress, being held June 8-11 in Frankfurt, Germany (Press release, Karyopharm, MAY 23, 2023, View Source [SID1234631963]).
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"We’ve made significant strides advancing our pipeline and demonstrating the potential benefit that XPO1 inhibition can deliver to patients with cancers characterized by high unmet needs," said Reshma Rangwala, MD, PhD, Chief Medical Officer of Karyopharm. "The presentations at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) highlight our continued pursuit of transformative research to positively impact patients’ lives and ultimately defeat cancer."
Details for the ASCO (Free ASCO Whitepaper) abstracts are as follows:
Abstract Title
Presentation Type
Abstract #
Session Date/Time
Myelofibrosis
Selinexor (SEL) plus Ruxolitinib (RUX) in JAK
Inhibitor (JAKi) Treatment-Naïve Patients with
Myelofibrosis: Updated results from XPORT-
MF-034
Poster
7063
Monday, June 5, 2023
8:00am – 11:00am CDT /
9:00am – 12:00pm EDT
Endometrial Cancer
ENGOT-EN20/GOG-3083/XPORT-EC-042 A
Phase 3, Randomized, Placebo-Controlled,
Double-Blind, Multicenter Trial of Selinexor in
Maintenance Therapy After Systemic Therapy
for Patients with P53 Wild-Type, Advanced or
Recurrent Endometrial Carcinoma
Poster
TPS5627
Monday, June 5, 2023
1:15pm – 4:45pm CDT /
2:15pm – 5:45pm EDT
Multiple Myeloma
Efficacy and Safety of 40 mg vs 60 mg Once
Weekly Selinexor in Combination with
Pomalidomide and Dexamethasone in
Relapsed and/or Refractory Multiple Myeloma
(RRMM)40 mg vs 60 mg in RRMM
Online Abstract Publication
e20006
Effectiveness of Anti-B-cell Maturation
Antigen (BCMA)-Targeting Therapy After
Selinexor Treatment
Online Abstract Publication
e20034
Details for the EHA (Free EHA Whitepaper) abstracts are as follows:
Abstract Title
Presentation Type
Abstract #
Session Date/Time
Myelofibrosis
Selinexor (SEL) plus Ruxolitinib (RUX) in JAK
Inhibitor (JAKi) Treatment-Naïve Patients with
Myelofibrosis: Updated results from XPORT-
MF-034
Poster
P1020
Friday, June 9, 2023
6:00pm – 7:00pm CEST /
12:00pm – 1:00pm EDT
Multiple Myeloma
Efficacy and Safety of 40 mg vs 60 mg Once
Weekly Selinexor in Combination with
Pomalidomide and Dexamethasone in
Relapsed and/or Refractory Multiple Myeloma
(RRMM)
Poster
P982
Friday, June 9, 2023
6:00pm – 7:00pm CEST /
12:00pm – 1:00pm EDT
Real-World Safety and Effectiveness of
Selinexor-based Regimens in Patients with
Relapsed and/or Refractory Multiple Myeloma
and Dialysis-Dependent Renal Impairment
Online Abstract Publication
PB2106
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 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) 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, China, South Korea, Canada, Israel and Taiwan. XPOVIO and NEXPOVIO is marketed by Karyopharm’s partners, Antengene, Menarini, Neopharm and FORUS, in China, South Korea, Singapore, Australia, Hong Kong, Germany, Austria, Israel and Canada.
Please refer to the local Prescribing Information for full details.
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: [email protected]
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.