Use of a kras g12c inhibitor in treating cancers

Abstract

The present disclosure provides uses for a KRASG12C inhibitor, such as the compound of Formula I (AMG 510, sotorasib) in treating cancers, such as non-small cell lung cancer, in subjects with certain characteristics.

Description

This disclosure provides the use of KRASG12C inhibitors, such as compounds of formula I (AMG510, sotorasib), in the treatment of cancers such as non-small cell lung cancer in subjects with specific characteristics. Abstract

Claims

1. A compound of Formula I or a pharmaceutically acceptable salt thereof, for use in treating KRAS G12C mutated non-small cell lung cancer in a subject in need thereof, wherein the use comprises administering to the subject a total daily dose of 960 mg of the compound of Formula I and wherein the subject has not received a prior systemic platinum-based chemotherapy.

2. A method of identifying a subject having non-small cell lung cancer as sensitive to treatment with a compound of Formula I or a pharmaceutically acceptable salt thereof, comprising (i) assaying a sample obtained from the subject for a KRAS G12C mutation and (ii) determining whether the subject has received a prior systemic platinum-based chemotherapy, wherein the subject is identified as sensitive to treatment with a compound of Formula I or a pharmaceutically acceptable salt thereof, when the sample is positive for a KRAS G12C mutation and the subject has not received a prior systemic platinum-based chemotherapy.

3. A compound of Formula I or a pharmaceutically acceptable salt thereof, for use in a method of treatment as determined for a subject having non-small cell lung cancer, comprising (i) assaying a sample obtained from the subject for a KRAS G12C mutation and (ii) determining whether the subject has received a prior systemic platinum-based chemotherapy, when the sample is positive for a KRAS G12C mutation and the subject has not received a prior systemic platinum-based chemotherapy.

4. The method according to claim 2, wherein the treatment comprises administering a total daily dose of 960 mg of the compound of Formula I or a pharmaceutically acceptable salt thereof to the subject.

5. The method according to claim 3, wherein the treatment comprises administering a total daily dose of 960 mg of the compound of Formula I or a pharmaceutically acceptable salt thereof to the subject.

6. The compound for use or the method according to any one of claim 1 to 5, wherein the prior platinum-based chemotherapy comprises administration of a compound comprising platinum.

7. The compound for use or the method according to claim 6, wherein the compound comprising platinum is cisplatin or carboplatin.

8. The compound for use or the method according to any one of claims 1 to 7, wherein the subject is 18 years or older.

9. The compound for use or the method according to any one of claims 1 to 8, wherein the compound of Formula I is administered as a free base.

10. The compound for use or the method according to any one of claims 1 to 9, wherein the compound of Formula I is administered as a pharmaceutical composition comprising the compound and a pharmaceutically acceptable excipient.

11. The compound for use or the method according to claim 10, wherein the pharmaceutical composition is a solid dosage form.

12. The compound for use or the method according to claim 11, wherein the pharmaceutical composition is for oral administration.

13. The compound for use or the method according to any one of claims 10 to 12, wherein the pharmaceutical composition is a tablet.

14. The compound for use or the method according to claim 13, wherein the tablet comprises a fraction of the total daily dose of the compound of Formula I.

15. The compound for use or the method according to any one of claims 1 and 4 to 14, wherein the total daily dose of the compound is administered once daily.

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