CLINICAL TRIALS PROFILE FOR SELINEXOR

505(b)(2) Clinical Trials for selinexor

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT02137356 ↗	Selinexor Combined With Standard Chemoradiation as Neoadjuvant Treatment in Locally Advanced Rectal Cancer	Unknown status	Karyopharm Therapeutics Inc	Phase 1	2014-12-01	Locally advanced rectal cancer (T3, T4 or lymph node positive tumors) are conventionally treated with 5FU / capecitabine based chemoradiation prior to surgical resection. This treatment is associated with only a 15-20% pathological complete response. Selinexor (KPT-330) is a Selective Inhibitor of Nuclear Export (SINE) XPO1 antagonist that has demonstrated radiosensitization with in vivo models and has suggested single agent activity against colorectal cancers in a Phase I trial. Here we perform a Phase I/Ib trial of standard chemoradiation combined with Selinexor. We hypothesize that tumors treated with this new combination will demonstrate an increased response rate compared to those treated with capecitabine-radiation alone.
New Combination	NCT02137356 ↗	Selinexor Combined With Standard Chemoradiation as Neoadjuvant Treatment in Locally Advanced Rectal Cancer	Unknown status	Karyopharm Therapeutics, Inc	Phase 1	2014-12-01	Locally advanced rectal cancer (T3, T4 or lymph node positive tumors) are conventionally treated with 5FU / capecitabine based chemoradiation prior to surgical resection. This treatment is associated with only a 15-20% pathological complete response. Selinexor (KPT-330) is a Selective Inhibitor of Nuclear Export (SINE) XPO1 antagonist that has demonstrated radiosensitization with in vivo models and has suggested single agent activity against colorectal cancers in a Phase I trial. Here we perform a Phase I/Ib trial of standard chemoradiation combined with Selinexor. We hypothesize that tumors treated with this new combination will demonstrate an increased response rate compared to those treated with capecitabine-radiation alone.
New Combination	NCT02137356 ↗	Selinexor Combined With Standard Chemoradiation as Neoadjuvant Treatment in Locally Advanced Rectal Cancer	Unknown status	Sheba Medical Center	Phase 1	2014-12-01	Locally advanced rectal cancer (T3, T4 or lymph node positive tumors) are conventionally treated with 5FU / capecitabine based chemoradiation prior to surgical resection. This treatment is associated with only a 15-20% pathological complete response. Selinexor (KPT-330) is a Selective Inhibitor of Nuclear Export (SINE) XPO1 antagonist that has demonstrated radiosensitization with in vivo models and has suggested single agent activity against colorectal cancers in a Phase I trial. Here we perform a Phase I/Ib trial of standard chemoradiation combined with Selinexor. We hypothesize that tumors treated with this new combination will demonstrate an increased response rate compared to those treated with capecitabine-radiation alone.

All Clinical Trials for selinexor

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01607892 ↗	Safety Study of the Selective Inhibitor of Nuclear Export (SINE) KPT-330 in Patients With Advanced Hematological Cancer	Completed	Karyopharm Therapeutics Inc	Phase 1	2012-07-23	The purpose of this research study is to find out more information relating to the highest dose of KCP-330 that can be given safely and side effects it may cause, to examine how the body affects KCP-330 concentrations in the blood (pharmacokinetics or PK), to examine the effects of KCP-330 on the body (pharmacodynamics or PDn) and to obtain information on its effectiveness in treating cancer.
NCT01607892 ↗	Safety Study of the Selective Inhibitor of Nuclear Export (SINE) KPT-330 in Patients With Advanced Hematological Cancer	Completed	Karyopharm Therapeutics, Inc	Phase 1	2012-07-23	The purpose of this research study is to find out more information relating to the highest dose of KCP-330 that can be given safely and side effects it may cause, to examine how the body affects KCP-330 concentrations in the blood (pharmacokinetics or PK), to examine the effects of KCP-330 on the body (pharmacodynamics or PDn) and to obtain information on its effectiveness in treating cancer.
NCT01607905 ↗	Safety Study of KPT-330 (Selinexor) in Patients With Advanced or Metastatic Solid Tumor Cancer	Completed	Karyopharm Therapeutics Inc	Phase 1	2012-06-18	Phase 1 study to evaluate the safety and tolerability of selinexor and determine the Recommended Phase 2 Dose (RP2D) of selinexor for advanced or metastatic solid tumor malignancies.

Clinical Trial Conditions for selinexor

Condition Name

Condition Name for selinexor
Intervention	Trials
Multiple Myeloma	23
Acute Myeloid Leukemia	10
Refractory Multiple Myeloma	5

Condition MeSH

Condition MeSH for selinexor
Intervention	Trials
Multiple Myeloma	43
Neoplasms, Plasma Cell	38
Leukemia, Myeloid, Acute	24

Clinical Trial Locations for selinexor

Trials by Country

Trials by Country for selinexor
Location	Trials
United States	369
China	81
Canada	42
Spain	23
India	22

Trials by US State

Trials by US State for selinexor
Location	Trials
New York	34
California	27
Ohio	24
Texas	23
Florida	20

Clinical Trial Progress for selinexor

Clinical Trial Phase

Clinical Trial Phase for selinexor
Clinical Trial Phase	Trials
PHASE3	3
PHASE2	16
PHASE1	10

Clinical Trial Status

Clinical Trial Status for selinexor
Clinical Trial Phase	Trials
RECRUITING	69
Not yet recruiting	26
Completed	25

Clinical Trial Sponsors for selinexor

Sponsor Name

Sponsor Name for selinexor
Sponsor	Trials
Karyopharm Therapeutics Inc	84
Karyopharm Therapeutics, Inc	41
National Cancer Institute (NCI)	21

Sponsor Type

Sponsor Type for selinexor
Sponsor	Trials
Other	155
Industry	148
NIH	21

Clinical Trials Update, Market Analysis, and Projection for Selinexor

Last updated: October 30, 2025

Introduction

Selinexor (brand name: Xpovio), developed by Karyopharm Therapeutics, is a first-in-class oral Selective Inhibitor of Nuclear Export (SINE) compound designed to facilitate the retention of tumor suppressor proteins within the nucleus and inhibit oncogenic activity. Approved by the U.S. Food and Drug Administration (FDA) in December 2019 for adults with relapsed refractory multiple myeloma (RRMM), Selinexor has garnered attention for its unique mechanism and potential applications across various hematologic and solid tumors. This report provides a comprehensive update on clinical trials, market dynamics, and projected growth trajectories for Selinexor through 2030.

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Clinical Trials Update

Current Clinical Landscape

Since its FDA approval, Selinexor's clinical pipeline has expanded significantly, with ongoing and completed trials spanning multiple cancer indications. The drug's core mechanism—nuclear export inhibition—positions it as a promising candidate for diverse malignancies, especially those resistant to standard therapies.

Approved Indications and Ongoing Trials

1. Multiple Myeloma (MM):
Selinexor’s primary approved use is in RRMM, typically in combination with dexamethasone, and in later-line settings. The BOSTON trial (Phase 3, NCT03110562) demonstrated that Selinexor plus bortezomib and dexamethasone significantly extended progression-free survival (PFS) compared to bortezomib and dexamethasone alone, leading to its approval.

2. Diffuse Large B-Cell Lymphoma (DLBCL):
A Phase 2 trial (NCT03625638) assessed Selinexor in relapsed/refractory DLBCL. Preliminary data suggest activity, prompting further studies to confirm efficacy and safety.

3. Solid Tumors:
Multiple trials evaluate Selinexor's activity in solid tumors, including ovarian, triple-negative breast cancer (TNBC), and non-small cell lung cancer (NSCLC). Notable among these is NCT04423765, a Phase 2 study combining Selinexor with chemotherapy in solid tumors.

4. Other Hematological Malignancies:
Trials are ongoing in acute myeloid leukemia (AML) (NCT03665549), investigating Selinexor as monotherapy and in combination with venetoclax.

Key Clinical Trial Results

• Efficacy:
  In RRMM, the combination of Selinexor with dexamethasone has shown overall response rates (ORRs) ranging from 25% to 35% in heavily pretreated populations. The BOSTON trial's median PFS reached 13.9 months versus 9.5 months in controls.

• Safety:
  Main adverse events include thrombocytopenia, fatigue, nausea, and hyponatremia. Dose modifications and supportive care have improved tolerability.

• Emerging Data:
  Early-phase studies in DLBCL and solid tumors show promising activity, although larger randomized trials are necessary for definitive evidence.

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Market Analysis

Current Market Landscape

1. Multiple Myeloma Market:
Selinexor entered a competitive landscape featuring several proteasome inhibitors, immunomodulatory drugs, monoclonal antibodies, and CAR-T therapies. The global multiple myeloma therapeutics market was valued at approximately $14 billion in 2021 and is projected to grow at a CAGR of 7–8% through 2030. Selinexor’s niche in refractory populations and as part of combination regimens positions it for steady uptake.

2. Hematologic Malignancies & Solid Tumors:
While hematologic cancers constitute the primary market for Selinexor, expanding into solid tumors like ovarian and TNBC could diversify revenue streams. These markets are driven by unmet medical needs, especially in treatment-resistant cases.

3. Competitive Dynamics:
Selinexor competes with existing targeted therapies, immunotherapies, and emerging agents (e.g., CAR-T, bispecific antibodies). Its unique mechanism provides a differentiation point but must demonstrate sustained efficacy and safety to secure long-term positioning.

Market Drivers and Barriers

Drivers:

• Increase in relapsed/refractory cases requiring novel therapies.
• Growing acceptance of nuclear export inhibition as a therapeutic strategy.
• Orally administered formulation enhances patient adherence.

Barriers:

• Adverse event profile necessitating careful management.
• Competition from other emerging treatments, including next-generation proteasome inhibitors and antibody-drug conjugates.

Market Forecast

The global Selinexor market is expected to grow significantly, driven by approvals beyond multiple myeloma into additional indications. Experts project a compound annual growth rate of approximately 12–15% for Selinexor-specific revenues, reaching $1.2–1.5 billion globally by 2030, contingent upon successful expanded indications and improved safety profiles.

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Future Projections

Regulatory Outlook

Karyopharm is actively pursuing FDA and EMA submissions for expanded indications, including DLBCL, AML, and solid tumors. The anticipated approval of Selinexor in these indications could propel sales growth substantially.

Pipeline Potential

• Combination Regimens:
  Combining Selinexor with CAR-T therapies or other immunotherapies could address resistant cancers, unlocking new markets.

• Biomarker Development:
  Biomarkers predicting response could optimize patient selection, improving outcomes and market penetration.

Challenges and Opportunities

While the drug’s mechanism fosters a broad therapeutic horizon, safety concerns remain a challenge. Investing in combination strategies that mitigate adverse events offers a significant opportunity. Likewise, targeting underserved indications maximizes commercial potential.

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Key Takeaways

• Robust Clinical Development:
  Selinexor has established efficacy in RRMM, with ongoing trials expanding into DLBCL, AML, and solid tumors. Results from these studies will be pivotal for revisiting its market position.

• Market Expansion Prospects:
  The global multiple myeloma market remains lucrative, with Selinexor poised to capitalize on the growing need for novel therapies targeting refractory disease. Expansion into additional hematologic and solid tumors could further augment revenues.

• Competitive Differentiation:
  Selinexor's unique mechanism offers a competitive advantage, though its safety profile necessitates ongoing optimization to maximize adoption.

• Regulatory Trajectory:
  Regulatory approvals for new indications could significantly accelerate market penetration, aligning with the broader movement towards personalized, targeted oncology treatments.

• Strategic Investment Opportunities:
  Stakeholders should monitor ongoing trial outcomes, safety data, and regulatory developments to inform strategic investments and partnership decisions.

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FAQs

1. What are the main clinical indications for Selinexor?
Selinexor is currently approved for relapsed/refractory multiple myeloma in adults and is under clinical evaluation for indications like diffuse large B-cell lymphoma, AML, and certain solid tumors.

2. How does Selinexor's mechanism of action differ from other cancer therapies?
Selinexor inhibits nuclear export protein XPO1, trapping tumor suppressor proteins within the nucleus, thereby restoring their activity and inducing apoptosis—a novel mechanism distinct from proteasome inhibitors or monoclonal antibodies.

3. What are the primary safety concerns associated with Selinexor?
Key adverse events include thrombocytopenia, nausea, fatigue, hyponatremia, and gastrointestinal symptoms. Proper dose adjustments and supportive care are essential for management.

4. What is the market outlook for Selinexor through 2030?
Growth is expected to be robust, with projected revenues reaching approximately $1.2–1.5 billion globally, driven by expanded indications and clinical validation in solid tumors.

5. Are there any upcoming regulatory decisions for Selinexor?
Karyopharm Therapeutics continues to seek regulatory approval for additional indications, with filings likely pending or under review for DLBCL, AML, and other cancers. The outcome of these decisions will shape its future market trajectory.

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References

1. Karyopharm Therapeutics. (2019). FDA Approves Xpovio (Selinexor) for Multiple Myeloma.
2. Chari, A., et al. (2020). “Selinexor in Multiple Myeloma.” N Engl J Med, 383(20), 1907-1917.
3. MarketWatch. (2022). Global Oncology Market Size & Analysis.
4. ClinicalTrials.gov. (Accessed 2023). Multiple Selinexor Trials.
5. Grand View Research. (2022). Cancer Therapeutics Market Size & Trends.