Osimertinib for use in the treatment of non-small cell lung cancer

Abstract

This provides a treatment option for patients with locally advanced, unresectable epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (stage III). [Solution] Osimertinib or a pharmaceutically acceptable salt thereof is provided for use in the treatment of patients with locally progressive, unresectable EGFR mutation-positive NSCLC who have not experienced disease progression after radical platinum-based radiochemotherapy.

Claims

1. Osimertinib or a pharmaceutically acceptable salt thereof for use in the treatment of patients with locally progressive, unresectable EGFR mutation-positive NSCLC who have not progressed after curative platinum-based radiochemotherapy.

2. The compound for use according to claim 1, wherein the unresectable EGFR mutation-positive NSCLC is considered to be curable by radiochemotherapy.

3. The compound for use according to claim 1 or 2, wherein the radiochemotherapy includes concurrent radiochemotherapy.

4. The compound for use according to any one of claims 1 to 3, wherein the radiochemotherapy includes sequential radiochemotherapy.

5. The compound for use according to any one of claims 1 to 4, wherein the radiochemotherapy includes a two-agent combination chemotherapy with a platinum-based drug.

6. The compound for use according to any one of claims 1 to 5, wherein the radiochemotherapy comprises a platinum-based agent selected from cisplatin or carboplatin.

7. The compound for use according to any one of claims 1 to 6, wherein the radiochemotherapy comprises a non-platinum agent selected from etoposide, vinorelbine, vinblastine, pemetrexed, paclitaxel, docetaxel, or gemcitabine.

8. The compound for use according to any one of claims 1 to 7, wherein the EGFR mutation-positive NSCLC comprises an activating mutation in the EGFR selected from exon 19 deletion or L858R substitution mutation.

9. The compound for use according to any one of claims 1 to 8, wherein the osimertinib or a pharmaceutically acceptable salt thereof is administered once daily.

10. The compound for use according to any one of claims 1 to 9, wherein the osimertinib or a pharmaceutically acceptable salt thereof is not administered to the patient before the completion of the radiochemotherapy.

11. The compound for use according to any one of claims 1 to 10, wherein the osimertinib or a pharmaceutically acceptable salt thereof is in tablet form.

12. The compound for use according to any one of claims 1 to 11, wherein the osimertinib or a pharmaceutically acceptable salt thereof is in the form of a mesylate.

13. A method for treating locally progressive stage III unresectable EGFR mutation-positive NSCLC in a human patient, the method comprising the step of administering osimertinib or a pharmaceutically acceptable salt thereof to the patient, wherein the disease has not progressed after curative platinum-based chemoradiotherapy.

14. Use of osimertinib or a pharmaceutically acceptable salt thereof in the manufacture of a drug for the treatment of patients with locally progressive, unresectable EGFR mutation-positive NSCLC who have not progressed after curative platinum-based radiochemotherapy.

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