Karyopharm Announces XPOVIO® (selinexor) Data to be Presented at the 2021 American Society of Clinical Oncology Annual Meeting

Rhea-AI Summary

Karyopharm Therapeutics (Nasdaq: KPTI) announced the selection of sixteen abstracts for virtual presentation at the ASCO Annual Meeting from June 4-8, 2021. Key highlights include clinical data on XPOVIO® (selinexor) from pivotal studies, showcasing its efficacy in treating multiple myeloma and other cancers. The presentations feature subgroup analyses from the Phase 3 BOSTON study and updates from various combination studies, emphasizing the potential of XPOVIO in overcoming treatment resistance.

Positive

• Presentation of clinical data at ASCO enhances visibility and credibility.
• Positive results from the Phase 3 BOSTON study for XPOVIO in older patients with multiple myeloma.
• Efficacy demonstrated in RAS-mutated multiple myeloma, showing potential for broader application.
• New data from ongoing studies could expand the use of XPOVIO in solid tumors.

Negative

• None.

NEWTON, Mass., May 19, 2021 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that sixteen abstracts have been selected for virtual presentation, including one oral presentation, at the upcoming 2021 American Society of Clinical Oncology (ASCO) Annual Meeting taking place June 4-8, 2021.

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 and patients with RAS-mutated multiple myeloma; (ii) updated data from the Pomalyst® (pomalidomide) and Kyprolis® (carfilzomib) arms of the Phase 1b/2 STOMP study evaluating XPOVIO in combination with backbone therapies in patients with relapsed or refractory multiple myeloma; (iii) new results from a Phase 1 study evaluating the combination of XPOVIO and pembrolizumab in advanced RAS mutant and RAS wild type colorectal cancer; (iv) results from gene set enrichment analyses identifying molecular predictors of response to XPOVIO from the Phase 2/3 SEAL study in patients with dedifferentiated liposarcoma (DDLS); and (v) updated overall survival (OS) 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 (MDS).

"We are honored to be sharing this broad set of clinical data with the medical and scientific community this year at ASCO, where we will be highlighting several important new datasets, including new subgroup analyses from both the BOSTON and STOMP studies in patients with relapsed or refractory multiple myeloma where we believe XPOVIO will become an important backbone therapy," said Sharon Shacham, PhD, MBA, Chief Scientific Officer of Karyopharm. "Additionally, we are pleased to see data from our growing pipeline of solid tumor studies, which will include new data from an ongoing combination study of XPOVIO and pembrolizumab in patients with advanced colorectal cancer as well as the discovery of certain molecular predictors of response to XPOVIO in patients with dedifferentiated liposarcoma, a difficult to treat cancer due to its resistance to chemotherapy and radiation. The data presented this year continue to demonstrate the broad clinical utility of XPO1 inhibition across a growing range of cancer types."

Select Abstracts Featuring XPOVIO® (selinexor) in Multiple Myeloma

1. Title: Survival Among Older Patients with Previously Treated Multiple Myeloma Treated with Selinexor, Bortezomib, and Dexamethasone (XVd) in the BOSTON study

Presenter: Thierry Facon, University Hospital
Abstract #: 8019
Date and time: Friday, June 4, 2021; 9:00 a.m. ET
Session type: Poster
Session: Hematologic Malignancies—Plasma Cell Dyscrasia
Highlights: In an older patient population with a poor prognosis, XVd compared to Vd was associated with an OS benefit, improved progression-free survival (PFS) and an increased overall response rate (ORR) with reduced peripheral neuropathy and requires relatively short and infrequent clinic visits. XVd may be an effective regimen for patients 65 years of age or older. Adverse events (AEs) in this study were generally consistent with other previously reported selinexor studies in multiple myeloma.

2. Title: Effects of Weekly Selinexor, Bortezomib, Dexamethasone (XVd) Versus Standard Twice Weekly bortezomib and dexamethasone (Vd) on RAS-mutated previously treated multiple myeloma (MM)

Presenter: Christopher J. Walker, Karyopharm Therapeutics Inc.
Abstract #: 8027
Date and time: Friday, June 4, 2021; 9:00 a.m. ET
Session type: Poster
Session: Hematologic Malignancies—Plasma Cell Dyscrasia
Highlights: Despite typically having the worst outcomes, patients with MM with any (K-, H- or N-) RAS mutation had a similar benefit from XVd as RAS wild-type MM, showing that the XVd combination can overcome therapy resistance characteristic of RAS-mutated MM. Mechanistically, selinexor induced down regulation of germinal center kinase and enhanced killing of RAS-mutated MM cells. With a manageable safety profile, the XVd regimen was able to overcome the therapeutic resistance of RAS-mutated multiple myeloma and improved PFS and OS in patients with RAS-mutated MM, and the data suggest that selinexor-containing regimens could be active in other RAS-mutant cancers. AEs in this study were generally consistent with other previously reported selinexor studies in MM.

3. Title: Effects of Refractory Status to Lenalidomide on Safety and Efficacy of Selinexor, Bortezomib, and Dexamethasone (XVd) Versus Bortezomib and Dexamethasone (Vd) in Patients with Previously Treated Multiple Myeloma

Presenter: Xavier Leleu, CHU de Poitiers, Hôpital La Mileterie
Abstract #: 8024
Date and time: Friday, June 4, 2021; 9:00 a.m. ET
Session type: Poster
Session: Hematologic Malignancies—Plasma Cell Dyscrasia
Highlights: In patients with previously treated multiple myeloma, PFS, ORR, and time to next treatment were significantly improved regardless of documented refractory status to any immunomodulatory drug (IMiD) or to lenalidomide specifically. These analyses support the use of the XVd combination for patients with disease refractory to lenalidomide and likely to any IMiD. AEs in this study were generally consistent with other previously reported selinexor studies in multiple myeloma.

4. Title: Oral Selinexor, Pomalidomide, and Dexamethasone (XPd) at Recommended Phase 2 Dose in Relapsed Refractory Multiple Myeloma (MM)

Presenter: Darrell White, QEII Health Sciences Center, Dalhousie University
Abstract #: 8018
Date and time: Friday, June 4, 2021; 9:00 a.m. ET
Session type: Poster Discussion Presentation
Session: Hematologic Malignancies—Plasma Cell Dyscrasia
Highlights: Once-weekly selinexor was shown in this Phase 1b/2 study to  be safely combined with Pomalyst® (pomalidomide) and low-dose dexamethasone (XPd) in patients with heavily pretreated MM. This all-oral XPd combination is highly active with an ORR of 65% at the recommended Phase 2 dose in 20 patients, compared to the expected ORR of ≤30% for the combination of Pomalyst® and dexamethasone (Pd) or selinexor and dexamethasone, and has thus far produced durable responses with a median PFS of 12.2 months. The data suggest that the regimen was active even in patients with daratumumab-refractory MM. AEs in this study were generally consistent with other previously reported selinexor studies in multiple myeloma.

5. Title: Once Weekly Selinexor, Carfilzomib, and Dexamethasone (XKd) in Carfilzomib Nonrefractory Multiple Myeloma (MM) Patients

Presenter: Cristina Gasparetto, Duke University Cancer Center
Abstract #: 8038
Date and time: Friday, June 4, 2021; 9:00 a.m. ET
Session type: Poster
Session: Hematologic Malignancies—Plasma Cell Dyscrasia
Highlights: In 27 patients with heavily pretreated MM (median of 4 lines of prior therapy), weekly XKd is highly active with an ORR of 78% and deep responses (≥VGPR 41%) with an overall PFS of 15 months; activity was strong even in patients with daratumumab refractory disease. AEs in this Phase 1/2b study were generally consistent with other previously reported selinexor studies in MM.

6. Title: Selinexor Containing Regimens in Patients with Multiple Myeloma (MM) Previously Treated with anti-CD38 Monoclonal Antibodies (aCD38 mAbs)

Presenter: Cristina Gasparetto, Duke University Cancer Center
Abstract #: e20020
Session type: Online abstract
Highlights: Selinexor-containing triplet combinations in 47 patients with MM previously treated with anti-CD38 mAb, most of whom had triple-class refractory MM, exhibit tolerability and comparable effectiveness to their most recent anti-CD38 mAb-containing regimens in this retrospective analysis. Compared to historical controls who did not receive selinexor, median OS was much longer among these patients. The results show that selinexor-containing regimens maintain high levels of anti-MM activity, even in patients whose disease is refractory to daratumumab, immunomodulatory drugs and proteasome inhibitors. AEs in this study were generally consistent with other previously reported selinexor studies in multiple myeloma.

Select Abstracts Featuring XPOVIO (selinexor) in Solid Tumors

7. Title: Molecular Predictors of Response to Selinexor in Advanced Unresectable De-differentiated Liposarcoma (DDLS)

Presenter: Christopher J. Walker, Karyopharm Therapeutics Inc.
Abstract #: 11509
Date and time: Friday, June 4, 2021; 9:00 a.m. ET
Session type: Oral presentation
Session: Emerging Trends in Sarcoma Precision Medicine
Highlights: The randomized Phase 3 SEAL study of selinexor versus placebo in patients with heavily pretreated  DDLS showed a significant improvement in PFS for selinexor. The molecular analyses reported here demonstrate that DDLS tumors responding to selinexor showed low expression of CALB1 and high GRM1. If validated, patients with DDLS whose tumors match this expression profile are especially likely to benefit from selinexor.

8. Title: Open-Label Phase 1 Study Evaluating the Tolerability and Anti-Tumor Activity of Selinexor and Pembrolizumab in Colorectal Cancer

Presenter: Talia Golan, Oncology Department Center Sheba Medical Center at Tel Hashomer
Session type: Online abstract
Abstract #: e15579
Highlights: Selinexor in combination with pembrolizumab has demonstrated disease control in patients with chemotherapy refractory, advanced/metastatic, microsatellite stable colorectal cancer (CRC). Greater anti-tumor activity was observed in patients with RAS mutations despite the absence of high microsatellite instability and/or deficient in mismatch repair. The therapy was well tolerated with no unanticipated adverse events observed.

9. Title: Selinexor in Combination with Weekly Paclitaxel in Patients with Advanced or Metastatic Solid Tumors: Results of an Open Label, Single-Center, Multi-arm Phase 1b Study

Presenter: Shannon Westin, The University of Texas MD Anderson Cancer Center
Abstract #: 5565
Date and time: Friday, June 4, 2021; 9:00 a.m. ET
Session type:  Poster
Session: Gynecologic Cancer
Highlights: Among 24 evaluable patients with heavily pretreated ovarian cancer, oral selinexor in combination with weekly paclitaxel resulted in an ORR of 17% and a clinical benefit rate (response + stable disease >12 weeks) of 58%. With prior taxane therapy, the ORR was 10% and with no prior taxane therapy, the ORR was 23%. The combination demonstrated promising clinical activity with manageable toxicity.

Abstracts Featuring Eltanexor in MDS

10. Title: Updated Overall Survival of Eltanexor for the Treatment of Patients with Hypomethylating Agent Refractory Myelodysplastic Syndrome

Presenter: Sangmin Lee, Weill Cornell Medical College
Abstract #: e19037
Session type: Online abstract
Highlights: Single-agent oral eltanexor was active in patients with high-risk, hypomethylating agent refractory MDS. Of the 20 enrolled patients, seven (35%) had marrow complete response (mCR), and five (25%) had stable disease (SD) for a total disease control (mCR+SD) rate of 60%. Of the 15 patients evaluable for efficacy, seven (47%) had mCR and five (33%) had SD. Patients who reached mCR (n=7) had significantly longer median OS than patients without mCR (n=8) or with progressive disease (n=3). Side effects were consistent with other studies of eltanexor without solid organ toxicity. Further evaluation of eltanexor in MDS as a single agent and in combination with other agents is ongoing.

Additional Abstracts to be Presented

11. Title: A Randomized, Open-label, Phase 3 Study of Low-dose Selinexor and Lenalidomide (Len) Versus Len Maintenance Post Autologous Stem Cell Transplant (ASCT) for Newly Diagnosed Multiple Myeloma (NDMM): ALLG MM23: Sealand

Presenter: Hang Quach, St. Vincent Hospital
Abstract #: TPS8055
Date and time: Friday, June 4, 2021; 9:00 a.m. ET
Session type: Poster
Session: Hematologic Malignancies—Plasma Cell Dyscrasia

12. Title: U.S. Budget Impact (BI) Model for Selinexor, Bortezomib, and Dexamethasone (XVd) for the Treatment of Patients with Previously Treated Multiple Myeloma (MM)

Presenter: Mike Dolph, McGill University
Abstract #: e18839
Session type: Online abstract

13. Title: SIENDO/ENGOT-EN5/GOG-3055: A Randomized Phase 3 Trial of Maintenance Selinexor Versus Placebo After Combination Platinum-based Chemotherapy in Advanced or Recurrent Endometrial Cancer

Presenter: Ignace Vergote, BGOG and University Hospitals Leuven, Leuven Cancer Institute
Abstract #: TPS5610
Date and time: Friday, June 4, 2021; 9:00 a.m. ET
Session type:  Poster
Session: Gynecologic Cancer

14. Title: A Phase 1/2 Study of Selinexor in Combination with Standard of Care Therapy for Newly Diagnosed or Recurrent Glioblastoma

Presenter: Yazmin Odia, Miami Cancer Institute, Baptist Health South Florida (BHSF)
Abstract #: TPS2071
Date and time: Friday, June 4, 2021; 9:00 a.m. ET
Session type:  Poster
Session: Central Nervous System Tumors

15. Title: Digital Measurement of Functional Status of Patients with Glioblastoma

Presenter: Yasaman Demastani, Karyopharm Therapeutics Inc.
Abstract #: 2016
Date and time: Friday, June 4, 2021; 9:00 a.m. ET
Session type:  Poster
Session: Central Nervous System Tumors 

16. Title: A Phase 1b/2 Study of Selinexor in Combination with Imatinib in Patients with Advanced Gastrointestinal
Stromal Tumor (GIST): SeliGIST/GEIS-41 Trial

Presenter: Cesar Serrano, West Virginia University School of Medicine Neurology & Neurosurgery
Abstract #: 11534
Date and time: Friday, June 4, 2021; 9:00 a.m. ET
Session type:  Poster
Session: Sarcoma

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. NEXPOVIO® (selinexor) has also been granted conditional marketing authorization for adult patients with heavily pretreated multiple myeloma by the European Commission. Karyopharm's supplemental New Drug Application (sNDA) requesting an expansion of its indication to include the treatment for patients with multiple myeloma after at least one prior therapy was approved by the FDA on December 18, 2020. 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) 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

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 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. 

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 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 first-in-class drugs directed against nuclear export for the treatment of cancer and other 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), is approved in the U.S. in multiple hematologic malignancy indications, including in combination with Velcade® (bortezomib) and dexamethasone for the treatment of adult patients with multiple myeloma after at least one prior therapy, in combination with dexamethasone for the treatment of adult patients with heavily pretreated multiple myeloma and as a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma. NEXPOVIO® (selinexor) has also been granted conditional marketing authorization in combination with dexamethasone for adult patients with heavily pretreated multiple myeloma by the European Commission. 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 expectations and plans relating to XPOVIO for the treatment of patients with relapsed or refractory multiple myeloma or certain solid 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 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 or regulatory approval of drug candidates by Karyopharm's competitors for products or product candidates in which Karyopharm is currently commercializing or developing; and Karyopharm's ability to obtain, maintain and enforce patent and other intellectual property protection for any of its products or product candidates. These and other risks are described under the caption "Risk Factors" in Karyopharm's Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, which was filed with the Securities and Exchange Commission (SEC) on May 4, 2021, 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.

XPOVIO^®(selinexor) is a registered trademark of Karyopharm Therapeutics Inc. Any other trademarks referred to in this presentation are the property of their respective owners.

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SOURCE Karyopharm Therapeutics Inc.

FAQ

What key data is being presented by Karyopharm Therapeutics at ASCO 2021?

Karyopharm is presenting sixteen abstracts, including data on XPOVIO® (selinexor), with highlights from Phase 3 BOSTON and other combination studies.

When will the ASCO Annual Meeting take place?

The ASCO Annual Meeting will occur from June 4-8, 2021.

What is the significance of the Phase 3 BOSTON study for KPTI?

The BOSTON study provides evidence of XPOVIO's efficacy in older patients with multiple myeloma, demonstrating an overall survival benefit.

How does XPOVIO perform in patients with RAS-mutated multiple myeloma?

XPOVIO has shown similar benefits in RAS-mutated multiple myeloma patients compared to those with RAS wild-type, indicating its potential to overcome therapy resistance.