Abstract 29P
Background
The aim of this study was to better understand the real-world safety profile of osimertinib in Chinese NSCLC patients (pts).
Methods
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.
Results
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: 29P
Safety summary
| Patients, n (%) | Overall (N=1,700) | ≥65 years (N=706) |
| Adverse drug reactions (ADRs) | 627 (36.9) | 254 (36.0) |
| Leading to dose interruption | 9 (0.5) | 3 (0.4) |
| Leading to dose reduction | 5 (0.3) | 2 (0.3) |
| Leading to treatment discontinuation | 32 (1.9) | 18 (2.5) |
| Leading to death | 1 (0.1) | 1 (0.1) |
| Most common ADRs (incidence ≥5%) | ||
| Platelet count decreased | 123 (7.2) | 53 (7.5) |
| White blood cell count decreased | 118 (6.9) | 40 (5.7) |
| Anaemia | 87 (5.1) | 44 (6.2) |
| Adverse events of any grade | 959 (56.4) | 395 (55.9) |
| Adverse events of Grade ≥3 | 165 (9.7) | 80 (11.3) |
| Serious adverse events | 102 (6.0) | 52 (7.4) |
Conclusions
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.
Clinical trial identification
NCT03485326.
Editorial acknowledgement
Medical writing and editorial support were provided by Costello Medical, which was funded by AstraZeneca China.
Legal entity responsible for the study
AstraZeneca China.
Funding
AstraZeneca China.
Disclosure
All authors have declared no conflicts of interest.