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Publication Number
US-12128045-B2
Publication Date
2024-10-29
Expiration Date
Abstract
A compound of formula I or a pharmaceutically acceptable salt or ester thereof is provided for the treatment of cancer wherein (i) the cancer is one that has the characteristic of being a type prone to being or becoming refractory or resistant to platinum drug based therapy and (ii) the treatment is with a dose of between 1 mg/m2 and 30 mg/m2 of compound per patient body surface area per administration. Method of treatment and novel dosage forms are also provided. Particularly treated are ovarian cancers, particularly those expressing a-folate receptors, including epithelial ovarian, fallopian tube or peritoneal cancer.
Core Innovation
The invention relates to a method of treating cancer in a patient in need thereof by administering a compound of formula I, or a pharmaceutically acceptable salt or ester thereof. The method targets cancers characterized as being types prone to being or becoming refractory or resistant to platinum drug based therapy, in particular platinum-resistant or platinum-refractory cancers, with special focus on tumors described as α-folate receptor (FR-α) expressing tumors, including HGSOC.
The document provides a dosing and administration regimen in which the compound of formula I, or a pharmaceutically acceptable salt or ester, is administered at a dose of from 6 mg/m2 to 14 mg/m2 per patient body surface area per administration. The regimen is specified as a 28-day cycle with each administration occurring at 14-day intervals.
The document also describes BTG945 as a trisodium salt of a cyclopenta[g]quinazoline antifolate/thymidylate synthase inhibitor, including first-in-human dose-escalation outcomes. The disclosed results describe partial responses or stable disease at lower doses with manageable toxicity, including avoidance of BOOP observed in a prior higher-dose regimen.
Claims Coverage
The partial content provides one independent claim: clm-00001. This claim covers treating platinum-refractory or platinum-resistant cancers with a compound of formula I (or a pharmaceutically acceptable salt or ester) using a specified dose range and a 28-day treatment cycle with administrations at 14-day intervals. Dependent claims are described as refining cancer subtype, route of administration, infusion/dose details, cumulative maximum dose constraints, and combination therapy components, including PARP inhibitors.
Platinum-refractory or platinum-resistant cancer treatment using compound of formula I
Treating a cancer in a patient in need thereof by administering to the patient a compound of formula I or a pharmaceutically acceptable salt or ester thereof, wherein the cancer has the characteristic of being a type prone to being or becoming refractory or resistant to platinum drug based therapy.
Dose range per administration and body surface area
Administering the compound of formula I, or a pharmaceutically acceptable salt or ester thereof, at a dose of from 6 mg/m2 to 14 mg/m2 of compound or pharmaceutically acceptable salt or ester per patient body surface area per administration.
28-day cycle with administrations at 14-day intervals
Scheduling each administration in a 28-day cycle at 14-day intervals.
Across the independent claim, the inventive coverage centers on administering a compound of formula I (or a salt or ester) for cancers prone to platinum resistance, using a defined per-administration dose range based on body surface area, and using a 28-day treatment cycle with administrations every 14 days. The partial content indicates dependent claims further narrow cancer subtype, routes, infusion/dose ranges, cumulative maximum dose over the course, and combination therapy with a PARP inhibitor.
Stated Advantages
Partial responses or stable disease at lower doses with manageable toxicity.
Avoidance of BOOP seen in a prior higher-dose regimen.
Documented Applications
Treating platinum-resistant or platinum-refractory cancers, including cancers described as α-folate receptor (FR-α) expressing tumors, notably HGSOC.
Treating ovarian cancer.
Combination therapy including administration of a PARP inhibitor to the patient.
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