On September 26, 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 International Myeloma Society (IMS) Annual Meeting, being held September 27-30 in Athens, Greece (Press release, Karyopharm, SEP 26, 2023, View Source [SID1234635410]). In addition, exploratory subgroup analyses from the SIENDO Study in patients with advanced or recurrent TP53 wild-type endometrial cancer will be presented in an oral session, "Abstract Session: Best Oral Session – Endometrial Cancer," at the 2023 European Society of Gynaecological Oncology (ESGO) Congress, being held September 28-October 1 in Istanbul, Turkey.
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"We are pleased to have a number of presentations at IMS and ESGO this year that continue to show the meaningful benefit achieved with selinexor across a number of tumor types," said Reshma Rangwala, MD, PhD, Chief Medical Officer of Karyopharm. "The breadth of data to be presented further demonstrates our commitment, as well as that of our collaborators, to develop first-in-class therapies that inhibit XPO1 with the goal to improve outcomes for patients across solid and hematological tumors."
Details for the Karyopharm presentations at ESGO are as follows:
Abstract Title
Presentation
Type
Abstract #
Session Date/Time
Endometrial Cancer
Long-term Follow up of Selinexor
Maintenance for Patients with TP53wt
Advanced or Recurrent Endometrial Cancer: A
Pre-Specified Subgroup Analysis from the
Phase 3 ENGO-EN5/GOG-3055/SIENDO Study
Oral
264
Sunday, October 1, 2023
12:05pm – 12:15 pm
GMT/ 5:05am -5:15am
EST
ENGOT-EN20/GOG-3083/XPORT-EC-042 a
Phase 3, Randomized, Placebo-Controlled,
Double-Blind, Multicenter Trial of Selinexor in
Maintenance Therapy for Patients with
TP53wt, Advanced or Recurrent Endometrial
Carcinoma
Poster
265
Saturday, September 30, 2023
15:05-15:50pm
GMT/11:05am – 11:50am
Details for the Karyopharm IMS posters are as follows:
Abstract Title
Presentation
Type
Abstract #
Session Date/Time
Multiple Myeloma
A Phase 3 Randomized, Open-label Trial of
Selinexor, Pomalidomide, and Dexamethasone
Versus Elotuzumab, Pomalidomide, and
Dexamethasone in Patients with Relapsed
or Refractory Multiple Myeloma
Poster
P-323
Thursday, September 28, 2023
12:30pm – 1:30pm EEST/
5:30am -6:30am EST
Effectiveness of anti-B-cell maturation antigen
(BCMA)-targeting therapy after selinexor
treatment
Poster
P-232
Thursday, September 28, 2023
12:30pm – 1:30pm EEST/
5:30am -6:30am EST
In addition, Karyopharm will be featured as part of the following alliance partner and independent investigator posters at IMS:
Abstract Title
Presentation
Type
Abstract #
Session Date/Time
Multiple Myeloma
African American Relapsed/Refractory
Multiple Myeloma Patients Have a Progression
Free Survival Benefit with Selinexor Treatment
in the STORM Study
Poster
P-241
Thursday, September 28, 2023
12:30pm – 1:30pm EEST/
5:30am -6:30am EST
Efficacy, Survival and Safety of Selinexor,
Bortezomib and Dexamethasone (SVD) in
Patients with Lenalidomide-Refractory
Multiple Myeloma: Subgroup Data from the
BOSTON Trial
Poster
P-295
Thursday, September 28, 2023
12:30pm – 1:30pm EEST/
5:30am -6:30am EST
Selinexor, Bortexomib, and Dexamethasone in
Patients with Previously Treated Multiple
Myeloma: Updated Results of BOSTON Trial by
Prior Therapies
Poster
P-297
Thursday, September 28, 2023
12:30pm – 1:30pm EEST/
5:30am -6:30am EST
Investigation of T-cell Fitness and Mechanisms
of Drug Resistance in Selinexor Treated
Patients with Relapsed/Refractory Multiple
Myeloma
Poster
P-396
Friday, September 29, 2023
1:15pm – 2:15pm EEST/
6:15am -7:15am EST
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.