Combination of XPO1 inhibitors and second agents for the treatment of prostate cancer
Inventors
Assignees
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Publication Number
US-12318386-B2
Publication Date
2025-06-03
Expiration Date
Abstract
This invention relates to a method of treating prostate cancer comprising administering a compound of Formula (I) or a salt thereof in combination with either abiraterone or enzalutamide.
Core Innovation
The invention relates to treating prostate cancer by administering a compound of Formula (I) together with abiraterone over a 28-day treatment cycle. The subject is an abiraterone-refractory subject in need thereof, and the combined amounts of the two components comprise an effective amount.
The compound of Formula (I) is administered on days 1-5, 8-12, 15-19, and 22-26 of the 28-day treatment cycle, while abiraterone is administered daily during the 28-day treatment cycle. The approach is described with rationale linked to AR/AR splice variant (AR-V7) resistance, and is supported by descriptions of XPO1 inhibition and AR signaling.
The disclosure further includes embodiments that connect the combination strategy to abiraterone-refractory and enzalutamide-refractory settings, including abiraterone/enzalutamide-naive subjects. In addition, embodiments reference optional prednisone with abiraterone, and provide supportive clinical-trial context and referenced xenograft/cell data involving KPT-8602 (eltanexor), abiraterone, and AR/AR-V7 effects.
Claims Coverage
The claims provide coverage for treating prostate cancer in an abiraterone-refractory subject using a combination of abiraterone and a compound of Formula (I), with the compound administered on specified day ranges within a 28-day cycle. The inventive core is supported by dependent claim refinements that specify dosing constraints and/or narrowed prostate cancer types and co-therapy options. Only one independent claim is provided in the supplied claim set.
Abiraterone-refractory prostate cancer combination administration over a 28-day cycle
A method of treating prostate cancer in an abiraterone-refractory subject in need thereof, comprising the combination administration to the subject over a 28-day treatment cycle of a first amount of abiraterone and a second amount of a compound of Formula (I) (or a pharmaceutically acceptable salt thereof), wherein the first and second amounts together comprise an effective amount.
Scheduled dosing of compound of Formula (I) within a 28-day cycle with daily abiraterone
The compound of Formula (I) is administered on days 1-5, 8-12, 15-19, and 22-26 of the 28-day treatment cycle, and abiraterone is administered daily during the 28-day treatment cycle.
Overall, the independent claim coverage centers on administering abiraterone plus a compound of Formula (I) to an abiraterone-refractory prostate cancer subject over a 28-day cycle, with the compound given on defined day ranges and abiraterone given daily throughout the cycle.
Stated Advantages
Documented Applications
Treating prostate cancer in an abiraterone-refractory subject using a combination of abiraterone and a compound of Formula (I) administered on specified day ranges within a 28-day treatment cycle.
Supportive clinical-trial context and referenced xenograft/cell data involving KPT-8602 (eltanexor), abiraterone, and AR/AR-V7 effects (including discussion of RECIST 1.1, PFS, and time on treatment as referenced in the provided partial content).
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