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

Abstract

The specification relates to epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) for use in the treatment of EGFR TKI-naive patients with locally-advanced or metastatic EGFR mutation-positive non-small cell lung cancer (NSCLC), wherein the EGFR TKI is administered in combination with pemetrexed and platinum chemotherapy.

Description

technical field [0001] This label describes an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) for use in the treatment of patients with locally advanced or metastatic EGFR mutation-positive non-small cell lung cancer (NSCLC) who have not received an EGFR TKI . In particular, this specification describes the combination of a second or third generation EGFR TKI with pemetrexed and platinum chemotherapy. Background technique [0002] Primary lung cancer is the most common form of cancer worldwide (accounting for approximately 13.5% of all new cancer cases in 2018), and it remains the leading cause of cancer-related death worldwide (accounting for 25.3% of all cancer deaths). Non-small cell lung cancer (NSCLC) accounts for approximately 80% to 90% of all lung cancers (National Comprehensive Cancer Network (NCCN) Guidelines for NSCLC 2019). [0003] Despite recent advances in early detection, in 70% to 80% of patients, lung cancer is diagnosed at a loca...

AI Technical Summary

Problems solved by technology

[0014] A separate study is ongoing for patients with locally advanced or metastatic NSCLC whose disease has progressed on prior EGFR TKI therapy and whose tumors harbor the T790M mutation within the epidermal growth factor receptor gene Phase II, open-label, randomized study of osimertinib compared to osimertinib plus carboplatin / pemetrexed (UMIN000024438), but results are unknown and cannot be directly applied in the first-line setting (i.e., not Patients who have received EGFR TKI)

Furthermore, there are no reported trials examining the outcomes of second- or third-generation EGFR TKIs in combination with pemetrexed and platinum chemotherapy in EGFR TKI-naïve EGFR mutation-positive NSCLC patients

[0015] Locally advanced cancer and metastatic EGFR mutation-positive NSCLC not amenable to curative surgery or radiation therapy are incurable conditions

Therefore, there remains a high unmet medical need for patients with these conditions

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