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Publication Number
US-12336985-B2
Publication Date
2025-06-24
Expiration Date
Abstract
Pituitary tumors may be reduced in size by administration of relacorilant. Pituitary tumors include, without limitation, non-secreting tumors, hormone-secreting tumors, adenomas, and carcinomas. Relacorilant administration may be effective to reduce hormone secretion from a hormone-secreting pituitary tumor, e.g., to reduce adrenocorticotrophic hormone (ACTH) secretion. A pituitary tumor may be imaged before and/or after relacorilant administration. Relacorilant may be administered independent of surgery, and before, during, or after surgery to treat a pituitary tumor. Relacorilant may aid or improve surgical outcomes, and may reduce the size or growth of pituitary tumor tissue before surgery, and any tumor tissue remaining following surgical treatment.Relacorilant may be orally administered for the treatment of pituitary tumors. Relacorilant may be orally administered to a fasted patient, or to a fed patient. Relacorilant may be administered in conjunction with other pituitary tumor targeting treatments, including surgical treatments, radiation treatments, chemotherapy for carcinomas, and other pharmaceutical treatments.
Core Innovation
The disclosed invention relates to methods to reduce the size of a visible pituitary macroadenoma tumor in a patient. The method includes imaging the visible pituitary macroadenoma tumor to determine a first size of the tumor, and administering relacorilant in daily oral doses for a period of time such that the tumor is reduced from the first size to a second size that is smaller than the first size. Relacorilant is provided as a specific glucocorticoid receptor modulator, identified by a chemical structure and name (CORT125134).
The invention specifies that the method applies to a visible pituitary macroadenoma tumor that has not been treated with radiation, and that imaging is used to determine tumor size prior to relacorilant administration. Tumor size is assessed again after relacorilant administration using imaging, with the goal of demonstrating reduction in tumor volume or size relative to the first size. The method is described in connection with pituitary macroadenomas, including non-secreting and hormone-secreting adenomas or macroadenomas.
In addition to size reduction, the disclosed method is described for hormone-secreting pituitary tumors, with a requirement that hormone secretion is decreased from a first amount to a second amount that is less than the first amount. The relacorilant regimen is also described in treatment contexts that include administration before and/or after transsphenoidal surgery for tumor resection, and combination with radiation treatment and/or cancer chemotherapy as part of therapy.
Claims Coverage
The document contains one independent claim directed to a method of reducing the size of a visible pituitary macroadenoma tumor, with dependent claims refining patient and treatment conditions, dosing options, imaging follow-up, hormone secretion effects, and therapy timing around surgery. The core inventive features are imaging-based determination of initial tumor size, oral administration of relacorilant as a glucocorticoid receptor modulator, and achieving a smaller second tumor size, with additional requirements for hormone reduction and adjunct treatment sequencing.
Imaging to determine a first tumor size of a visible pituitary macroadenoma
Imaging the visible pituitary macroadenoma tumor effective to determine a first size of said tumor.
Daily oral relacorilant for reducing visible pituitary macroadenoma from first size to second smaller size
Administering daily oral doses of relacorilant, where relacorilant is a glucocorticoid receptor modulator and is effective to reduce the size of the visible pituitary macroadenoma tumor from said first size to a second size, wherein said second size is smaller than the first size.
Visible pituitary macroadenoma tumor not having been treated with radiation
Limiting the method to a visible pituitary macroadenoma tumor in which said tumor has not been treated with radiation.
Second imaging to measure the visible pituitary macroadenoma tumor after relacorilant administration
Measuring said visible pituitary macroadenoma tumor after relacorilant administration using a second imaging of the visible pituitary macroadenoma tumor.
Hormone-secreting tumor requires decreasing hormone secretion amount
Applying the method to a visible hormone-secreting pituitary macroadenoma tumor to reduce the tumor size from a first size to a second size and to decrease hormone secretion from a first amount to a second amount that is less than the first amount.
Administration before surgery for resection of a visible pituitary macroadenoma tumor
Administering relacorilant before surgery to resect a visible pituitary macroadenoma tumor.
Post-surgery relacorilant with adjunct radiation treatment and/or cancer chemotherapy
Administering relacorilant to a patient after surgery for resection of a visible pituitary macroadenoma tumor, where radiation treatment and/or cancer chemotherapy is additionally administered.
Overall, the claim coverage centers on an imaging-to-size workflow combined with daily oral relacorilant to reduce a visible pituitary macroadenoma tumor to a smaller second size. The claims also include radiation-naive tumors, second imaging after administration, decreased hormone secretion for hormone-secreting tumors, and treatment timing before or after surgery, including adjunct radiation treatment and/or cancer chemotherapy.
Stated Advantages
Reducing the size of a visible pituitary macroadenoma tumor from a first size to a second smaller size.
Reducing hormone secretion in hormone-secreting pituitary macroadenomas by decreasing hormone secretion from a first amount to a second amount that is less than the first amount.
Supports imaging-based diagnosis and monitoring by assessing tumor size before and after relacorilant administration using imaging.
Documented Applications
Treatment of a visible pituitary macroadenoma tumor not previously treated with radiation by daily oral relacorilant administered after imaging-based determination of first tumor size.
Management of hormone-secreting pituitary macroadenomas, including reduction in tumor size and decreased hormone secretion.
Neoadjuvant or pre-surgical use and post-surgical use of relacorilant in connection with transsphenoidal surgery for tumor resection.
Combination therapy in which relacorilant is administered in conjunction with radiation treatment and/or cancer chemotherapy after surgery.
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