Therapeutic compositions, combinations, and methods of use
Inventors
Assignees
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Publication Number
US-11517573-B2
Publication Date
2022-12-06
Expiration Date
Abstract
This invention relates to methods comprising administering a FAK inhibitor (e.g., VS-6063) in combination with a dual RAF/MEK inhibitor (e.g., CHS 126766) that are useful in the treatment of abnormal cell growth, such as cancer, in a subject such as humans.
Core Innovation
The disclosure relates to a method of treating ovarian cancer or non-small cell lung cancer in a subject in need thereof. The method comprises orally administering an effective amount of CH5126766, or a pharmaceutically acceptable salt thereof, in combination with an effective amount of defactinib, or a pharmaceutically acceptable salt thereof.
The combination is used within a defined treatment cycle. CH5126766, or a pharmaceutically acceptable salt thereof, is administered twice a week, and defactinib, or a pharmaceutically acceptable salt thereof, is administered twice daily for three weeks, followed by one week in which CH5126766 is not administered while defactinib continues.
The disclosure further characterizes the cancers with mutations, including RAS, BRAF, and NF-1, and describes genetic subgroups including KRAS and NRAS in the clinical context. The document states that CH5126766 and defactinib are orally administered as a combination regimen intended for treating ovarian cancer or non-small cell lung cancer.
Claims Coverage
One independent claim is provided, covering an oral combination regimen with a defined cyclic schedule. The independent claim includes one key inventive feature: the combination of CH5126766 with defactinib and the specific cycle pattern.
Oral combination treatment with CH5126766 and defactinib cycle
A method of treating ovarian cancer or non-small cell lung cancer comprising orally administering an effective amount of CH5126766 (or a pharmaceutically acceptable salt thereof) in combination with an effective amount of defactinib (or a pharmaceutically acceptable salt thereof), wherein CH5126766 is administered twice a week and defactinib is administered twice daily for three weeks, followed by one week in which CH5126766 is not administered while defactinib continues.
The claim coverage centers on an orally administered combination regimen of CH5126766 and defactinib delivered on a specific cycle schedule, with CH5126766 twice weekly for three weeks followed by a one-week interruption and defactinib twice daily continuing through the cycle.
Stated Advantages
The combination is tolerable in a Phase I clinical trial context.
The combination is described as highly active in KRAS/NRAS-mutant tumors.
Documented Applications
Phase I clinical trial example NCT03875820, including tolerability/safety observations and preliminary anti-tumor activity in KRAS/NRAS-mutant ovarian, NSCLC, colorectal, and pancreatic cancers.
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