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CLINICAL TRIALS PROFILE FOR XPOVIO

All Clinical Trials for xpovio

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.
NCT02025985 ↗	Study of KPT-330 (Selinexor) in Female Patients With Advanced Gynaecologic Malignancies	Completed	Karyopharm Therapeutics Inc	Phase 2	2014-04-09	The primary trial objective is to determine the efficacy of KPT-330 (selinexor) in participants with advanced or metastatic gynaecological cancers by disease control rate (complete response (CR) or partial response (PR) or stable disease (SD) for at least 12 weeks, assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
NCT02025985 ↗	Study of KPT-330 (Selinexor) in Female Patients With Advanced Gynaecologic Malignancies	Completed	Karyopharm Therapeutics, Inc	Phase 2	2014-04-09	The primary trial objective is to determine the efficacy of KPT-330 (selinexor) in participants with advanced or metastatic gynaecological cancers by disease control rate (complete response (CR) or partial response (PR) or stable disease (SD) for at least 12 weeks, assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
NCT02178436 ↗	Gemcitabine, Nab-paclitaxel and KPT-330 in Advanced Pancreatic Cancer	Recruiting	National Cancer Institute (NCI)	Phase 1/Phase 2	2014-10-31	This partially randomized phase Ib/II trial studies the side effects and best dose of selinexor when given together with gemcitabine and nab-paclitaxel, and to see how well they work in treating patients with pancreatic cancer that has spread to other parts of the body (metastatic). Drugs used in chemotherapy, such as selinexor, gemcitabine and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
NCT02178436 ↗	Gemcitabine, Nab-paclitaxel and KPT-330 in Advanced Pancreatic Cancer	Recruiting	Barbara Ann Karmanos Cancer Institute	Phase 1/Phase 2	2014-10-31	This partially randomized phase Ib/II trial studies the side effects and best dose of selinexor when given together with gemcitabine and nab-paclitaxel, and to see how well they work in treating patients with pancreatic cancer that has spread to other parts of the body (metastatic). Drugs used in chemotherapy, such as selinexor, gemcitabine and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
NCT02323880 ↗	Selinexor in Treating Younger Patients With Recurrent or Refractory Solid Tumors or High-Grade Gliomas	Recruiting	National Cancer Institute (NCI)	Phase 1	2015-10-05	This phase I trial studies the side effects and best dose of selinexor in treating younger patients with solid tumors or central nervous system (CNS) tumors that have come back (recurrent) or do not respond to treatment (refractory). Drugs used in chemotherapy, such as selinexor, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Clinical Trial Conditions for xpovio

Condition Name

Condition Name for xpovio
Intervention	Trials
Multiple Myeloma	4
Ovarian Carcinoma	2
Refractory Plasma Cell Myeloma	2
Coronavirus Infection	2

Condition MeSH

Condition MeSH for xpovio
Intervention	Trials
Neoplasms, Plasma Cell	9
Multiple Myeloma	9
Carcinoma	4
Neoplasms	3

Clinical Trial Locations for xpovio

Trials by Country

Trials by Country for xpovio
Location	Trials
United States	79
Greece	4
China	3
Denmark	3
Israel	2

Trials by US State

Trials by US State for xpovio
Location	Trials
New York	7
California	6
Florida	6
Texas	5
Minnesota	4

Clinical Trial Progress for xpovio

Clinical Trial Phase

Clinical Trial Phase for xpovio
Clinical Trial Phase	Trials
Phase 2	13
Phase 1/Phase 2	6
Phase 1	5

Clinical Trial Status

Clinical Trial Status for xpovio
Clinical Trial Phase	Trials
Recruiting	13
Not yet recruiting	7
Completed	3

Clinical Trial Sponsors for xpovio

Sponsor Name

Sponsor Name for xpovio
Sponsor	Trials
Karyopharm Therapeutics Inc	13
National Cancer Institute (NCI)	11
Karyopharm Therapeutics, Inc	3

Sponsor Type

Sponsor Type for xpovio
Sponsor	Trials
Industry	19
Other	14
NIH	11

Xpovio Market Analysis and Financial Projection

XPOVIO: Clinical Trials, Market Analysis, and Projections

Introduction to XPOVIO

XPOVIO, also known as selinexor, is a groundbreaking drug developed by Karyopharm Therapeutics. It functions as a Selective Inhibitor of Nuclear Export (SINE) compound, specifically targeting the nuclear export protein XPO1. By inhibiting XPO1, XPOVIO retains tumor suppressor proteins within the nucleus, enhancing their anti-cancer activity[2][4].

Mechanism of Action

XPOVIO works by selectively binding to and inhibiting the nuclear export protein XPO1. This mechanism is crucial in retaining tumor suppressor proteins in the nucleus, where they can exert their anti-cancer effects. This unique action sets XPOVIO apart from other cancer therapies, making it a significant advancement in oncology[2][4].

Clinical Trials and Efficacy

Multiple Myeloma Trials

The efficacy of XPOVIO in multiple myeloma was evaluated in a multicenter, single-arm, open-label trial involving 202 patients. Of these, 83 patients provided data for the assessment of benefits. The trial showed that 21 of 83 patients (25%) treated with XPOVIO in combination with dexamethasone experienced an improvement in their disease that lasted approximately 4 months. The overall response rate (ORR) was 25.3%, with 1 patient achieving a stringent complete response, 4 achieving a very good partial response, and 16 achieving a partial response[1].

In another significant trial, the BOSTON study, a Phase 3 trial, demonstrated that the combination of selinexor with bortezomib and dexamethasone (SVd) reduced the risk of disease progression or death by 30% compared to the standard bortezomib and dexamethasone (Vd) regimen[2].

Diffuse Large B-Cell Lymphoma (DLBCL) Trials

XPOVIO has also been approved under accelerated approval for adult patients with relapsed or refractory DLBCL, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy. This approval was based on the response rate observed in clinical trials. Continued approval is contingent upon verifying and describing clinical benefits in confirmatory trials[3][4].

Market Analysis

Current Market and Revenue

As of the third quarter of 2024, XPOVIO has shown strong market performance. Karyopharm Therapeutics reported U.S. net product revenue of $29.5 million for XPOVIO, supported by quarter-over-quarter double-digit growth in demand. The drug has seen significant use in both community and academic settings, with approximately 60% of overall net product revenues coming from the community setting[5].

Market Projections

The multiple myeloma market, in which XPOVIO plays a significant role, is projected to grow substantially. By 2034, the market is expected to reach USD 38.1 billion, exhibiting a compound annual growth rate (CAGR) of 8% during 2024-2034. This growth is driven by the rising geriatric population and advancements in therapeutic options like XPOVIO[2].

For XPOVIO specifically, the market forecast is positive, with continued regulatory and reimbursement approvals globally. The drug has recently received favorable reimbursement decisions in France, Italy, and additional regulatory approvals in several other countries, expanding its global reach[5].

Regulatory Milestones

XPOVIO has received several key regulatory approvals:

• Multiple Myeloma: Approved in combination with VELCADE (bortezomib) and dexamethasone (XVd) for patients with multiple myeloma after at least one prior therapy, and in combination with dexamethasone for heavily pre-treated multiple myeloma patients[4].
• DLBCL: Approved under accelerated approval for adult patients with relapsed or refractory DLBCL after at least two lines of systemic therapy[3][4].

Safety and Side Effects

The safety of XPOVIO was evaluated in the same clinical trial that assessed its efficacy. The trial included 202 patients who provided data for the evaluation of side effects. While the drug has shown promising efficacy, it is not without side effects. Patients should be closely monitored for adverse reactions, and the treatment should be administered until disease progression or unacceptable toxicity[1].

Future Development and Trials

Karyopharm Therapeutics continues to advance XPOVIO through various clinical trials and indications. For example, the Phase 3 SENTRY trial is ongoing, focusing on JAKi naïve myelofibrosis, with top-line data expected in the second half of 2025[5].

Global Access and Expansion

XPOVIO has been expanding its global footprint with recent regulatory approvals in Turkiye, South Korea, Thailand, and Malaysia. Favorable reimbursement decisions in France and Italy have also contributed to its growing market presence[5].

Key Takeaways

• Mechanism of Action: XPOVIO inhibits the nuclear export protein XPO1, retaining tumor suppressor proteins in the nucleus.
• Clinical Trials: Significant efficacy in multiple myeloma and DLBCL trials, with ongoing studies in other indications.
• Market Projections: The multiple myeloma market is expected to reach USD 38.1 billion by 2034, with XPOVIO playing a crucial role.
• Regulatory Approvals: Approved for multiple myeloma and DLBCL, with ongoing regulatory activities globally.
• Safety and Side Effects: Patients should be monitored for adverse reactions, and treatment should be administered until disease progression or unacceptable toxicity.

FAQs

What is the mechanism of action of XPOVIO?

XPOVIO functions by selectively binding to and inhibiting the nuclear export protein XPO1, retaining tumor suppressor proteins within the nucleus to enhance their anti-cancer activity[2][4].

What are the approved indications for XPOVIO?

XPOVIO is approved for multiple myeloma in combination with VELCADE and dexamethasone, and in combination with dexamethasone for heavily pre-treated multiple myeloma patients. It is also approved under accelerated approval for relapsed or refractory DLBCL after at least two lines of systemic therapy[4].

What were the key findings from the clinical trials of XPOVIO in multiple myeloma?

In the clinical trial, 21 of 83 patients (25%) treated with XPOVIO in combination with dexamethasone experienced an improvement in their disease that lasted about 4 months. The overall response rate (ORR) was 25.3%[1].

What is the projected market size for the multiple myeloma market by 2034?

The multiple myeloma market is expected to reach USD 38.1 billion by 2034, exhibiting a CAGR of 8% during 2024-2034[2].

What are the ongoing clinical trials and future development plans for XPOVIO?

Karyopharm Therapeutics is conducting the Phase 3 SENTRY trial for JAKi naïve myelofibrosis, with top-line data expected in the second half of 2025. The company continues to expand XPOVIO's global reach through regulatory approvals and favorable reimbursement decisions[5].

Sources

1. FDA, "Drug Trials Snapshots: XPOVIO - FDA", July 16, 2019.
2. Biospace, "Multiple Myeloma Market Size to Reach USD 38.1 Billion by 2034", July 17, 2024.
3. GII Research, "XPOVIO Drug Insight and Market Forecast - 2032", December 1, 2023.
4. Karyopharm Therapeutics, "Karyopharm Therapeutics Provides Endometrial Cancer Program Update", December 3, 2024.
5. Karyopharm Therapeutics, "Karyopharm Reports Third Quarter 2024 Financial Results and Highlights Recent Company Progress", November 5, 2024.