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P2.14 - Targeted Therapy (ID 183)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Targeted Therapy
- Presentations: 1
- Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
P2.14-55 - Real-World Safety and Efficacy Data of Osimertinib in Patients from Japan with EGFR T790M-Positive NSCLC (ID 1601)
10:15 - 18:15 | Author(s): Kei Sakamoto
Osimertinib, a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), was approved in Japan on 28 March 2016 as second- or later-line treatment for patients with EGFR T790M mutation-positive non-small cell lung cancer (NSCLC) who have progressed on EGFR-TKIs. Post-marketing activities included the Japan-local All-patient Clinical Experience Investigation, reporting Japanese real-world safety and efficacy of osimertinib in the approved indication.Method
Overall, 3629 patients investigated at 718 hospitals between 28 March 2016 and 31 August 2018 were included. Adverse events were assessed by attending physicians to determine whether they were possibly causally-related to osimertinib. Osimertinib antitumour activity was evaluated by attending physicians using RECIST version 1.1. Progression-free survival (PFS) and overall survival (OS) were also analysed. The planned observation period was 12 months.Result
The median observation period for patients in the safety analysis set (n=3578) was 343 days (range: 1–764). Adverse drug reactions occurred in 58.1% (2079/3578) of patients. Adverse drug reactions (as per Japanese Prescribing Information) of interstitial lung disease, prolonged QT interval, liver disorder, and haematotoxicity were reported in 6.8% (245/3578) (Gr≥3, 2.9% [104/3578]), 1.3% (45/3578) (Gr≥3, 0.1% [5/3578]), 5.9% (212/3578) (Gr≥3, 1.0% [35/3578]), and 11.4% (409/3578) (Gr≥3, 2.9% [104/3578]) of patients, respectively. The objective response rate and disease control rates for patients in the efficacy analysis set (n=3563) were 69.9% (2492/3563; 95% confidence interval [CI] 68.4, 71.4) and 86.7% (3090/3563; 95% CI 85.6, 87.8). PFS rates at 6 months and 12 months were 77.4% (95% CI 75.9, 78.9) and 53.2% (95% CI 51.3, 55.1). OS rates at 6 months and 12 months were 88.3% (95% CI 87.2, 89.4) and 75.4% (95% CI 73.8, 77.0). Selected subgroup analyses of efficacy are presented in Table 1.
These data support the currently established benefit–risk assessment of osimertinib in patients with EGFR T790M positive NSCLC.
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