Consistent efficacy of osimertinib in Chinese and global population

The efficacy and safety data of adjuvant osimertinib treatment in the Chinese subgroup of the phase 3 ADAURA trial are consistent with the results of the global population.

Previously, the phase 3 ADAURA trial (NCT02511106) demonstrated a significant disease-free survival (DFS) benefit of adjuvant treatment with osimertinib versus placebo in patients with stage IB–IIIA, resected, EGFR-mutated non-small cell lung cancer (NSCLC) [1]. Because EGFR mutation is a common characteristic in Chinese lung cancer patients, a subgroup analysis of Chinese participants of ADAURA was performed. Dr Jie Wang (Beijing Cancer Hospital, China) presented the results [2].

Of 682 patients globally enrolled in ADAURA, 159 patients (68 patients with stage IB disease, 91 patients with stage II–IIIA disease) originated from 30 centres in China; 77 in the osimertinib arm and 82 in the placebo arm. Baseline characteristics were generally balanced between treatment arms. Compared with the global population, a higher proportion of patients in the Chinese cohort was younger than 65 years (74% vs 56%), had stage IB disease (43% vs 32%), and had EGFR L858R mutation (58% vs 45%); also, a higher number of Chinese patients on the placebo arm received adjuvant chemotherapy.

In the global ADAURA population, osimertinib significantly improved DFS (HR 0.20; P<0.001) and progression-free survival (HR 0.17; P<0.001) compared with placebo in stage IB–IIIA patients [1]. In the total Chinese cohort, median DFS was not reached versus 24.9 months (HR 0.18) in the osimertinib and placebo arms, respectively. In the Chinese stage II–IIIA cohort, the median DFS was not reached versus 18.3 months (HR 0.16), respectively. All pre-specified subgroups of the Chinese cohort with sufficient events for analysis demonstrated a benefit in DFS with osimertinib versus placebo. The safety profile in the Chinese cohort was consistent with that of the global ADAURA population.

In conclusion, the efficacy and safety data of adjuvant osimertinib treatment in the Chinese subgroup of ADAURA was consistent with that of the global population. This supports adjuvant osimertinib as an effective treatment for Chinese patients with resectable stage IB–IIIA EGFR-mutated NSCLC.

1. Wu Y-L, et al. N Engl J Med 2020; 383: 1711–1723.


2. Jie W, et al. Adjuvant osimertinib in patients (pts) with stage IB–IIIA EGFR mutation-positive (EGFRm) NSCLC after complete tumour resection: ADAURA China subgroup analysis. Abstract 85P. ELCC 2022 Virtual Meeting, 30 March–02 April.

 

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Posted on 25 May, 2022