29P Real-world safety of osimertinib in Chinese patients with non-small cell lung cancer (NSCLC)

The aim of this study was to better understand the real-world safety profile of osimertinib in Chinese NSCLC patients (pts). This was a prospective, observational study conducted in Chinese NSCLC pts who received ≥1 dose of osimertinib. Pts were followed up for 12 months after enrolment or until 30 days after osimertinib discontinuation, whichever occurred earlier. The primary endpoint was the incidence of adverse drug reactions (ADRs) in the overall pts. Secondary endpoints included the incidences of adverse events (AEs), serious AEs (SAEs), AEs of special interests (AESIs) in the overall pts, and the incidences of ADRs, AEs, SAEs, and AESIs in pts ≥65 years old. AESIs assessed in this study were QTc prolongation and interstitial lung disease/pneumonitis-like events. From 20 Apr 2020 to 1 Aug 2022, 1,700 pts were enrolled from 30 centres in China. By the data cut-off (3 Aug 2023), 1,301 (76.5%) pts completed the study. Of the enrolled pts, median age (Q1, Q3) was 62 (54, 69) years, with 706 (41.5%) ≥65 years old. Osimertinib was administered as first-line, second-line, ≥third-line, adjuvant, and neo-adjuvant therapy in 764 (44.9%), 581 (34.2%), 243 (14.3%), 77 (4.5%), and 4 (0.2%) pts. Median total exposure of osimertinib (Q1, Q3) was 384 (322, 479) days in the overall pts and 376 (299, 470) days in pts ≥65 years old. In overall pts, ADRs, AEs, and SAEs occurred in 627 (36.9%), 959 (56.4%), and 102 (6.0%) patients, respectively. AESIs occurred in 59 (3.5%) patients, with 41 (2.4%) and 19 (1.1%) patients experiencing QTc prolongation and interstitial lung disease/pneumonitis-like events, respectively. The safety profile of pts ≥65 years old was consistent with that of the overall pts.Table: 29PSafety summaryPatients, n (%)Overall (N=1,700)≥65 years (N=706)Adverse drug reactions (ADRs)627 (36.9)254 (36.0)Leading to dose interruption9 (0.5)3 (0.4)Leading to dose reduction5 (0.3)2 (0.3)Leading to treatment discontinuation32 (1.9)18 (2.5)Leading to death1 (0.1)1 (0.1)Most common ADRs (incidence ≥5%)Platelet count decreased123 (7.2)53 (7.5)White blood cell count decreased118 (6.9)40 (5.7)Anaemia87 (5.1)44 (6.2)Adverse events of any grade959 (56.4)395 (55.9)Adverse events of Grade ≥3165 (9.7)80 (11.3)Serious adverse events102 (6.0)52 (7.4) Open table in a new tab In this largest real-word study of NSCLC patients receiving osimertinib in Chinese real-world clinical practice, osimertinib was well-tolerated and no new safety signals were identified.