Introduction
ADAURA Global Clinical Study, Phase II-IIIA Adjuvant Osimertinib EGFR mutation-positive NSCLC brought an overwhelming DFS benefit, reducing the risk by 83%(HR 0.17), and significantly reducing local recurrence( Recurrence rate 7% vs. 18%) and distant recurrence (recurrence rate 4% vs. 28%), especially significantly lower central Nervous system(CNS)progression (ie, brain recurrence) or risk of death 82%.
Osimertinib changed the clinical practice of early and mid-stage adjuvant with ADAURA study data, and became the first approved for IB in China in April 2021 -Targeted drugs for postoperative adjuvant therapy in patients with stage IIIA EGFR-mutant NSCLC. And the program has been included in the unanimous recommendation of the Chinese Medical Association, the Chinese Anti-Cancer Association, the American NCCN, ASCO, ESMO and other major guidelines at home and abroad. The Chinese subgroup analysis data of this study have been released at the 2022 European Lung Cancer Congress(ELCC).
Better efficacy and more amazing data;
fill The blank of adjuvant therapy data for Chinese stage IB patients
Chinese subgroup analysis was included 159 Chinese patients, the study design is shown in Figure 1.
Figure 1: ADAURA’s research design
The primary endpoint of the study is the investigator-assessed DFS in patients with stage II-IIIA disease(disease-free survival). As can be seen from the published data, the results of the study There is a clear trend of benefit(Figure 2)and the data is more amazing, DFS HR 0.16(95%CI 0.08-0.31). This means that stage II-IIIA patients with adjuvant osimertinib had an 84% reduction in the risk of disease recurrence or death (DFS HR=0.17 in the global population, reducing 83% reduction in the risk of disease recurrence or death)[Median DFS: not achieved with osimertinib(NR) vs placebo 18.3 months];
: Main Study
The secondary endpoint of the study was DFS in patients with stage IB-IIIA, and the results of this study also showed a clear trend of benefit(Figure 3)And the data is also amazing, DFS HR 0.18(95%CI 0.10-0.33) (DFS HR=0.20 in the global population, reducing the risk of disease recurrence or death by 80%)[Median DFS: not achieved with osimertinib(NR) span>vs placebo 24.9 months];
Figure 3: Secondary endpoint: DFS in IB-IIIA NSCLC patients
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It is worth mentioning that compared with the global cohort, the Chinese subgroup included more IB population (43% vs 32%) (Table 1). 1), which is also closer to the current clinical reality in China. Compared with other first- or second-generation EGFR-TKI adjuvant therapy studies, such as ADJUVANT, EVIDENCE, etc., were not included in stage IB, The results of the Chinese subgroupUndoubtedly, it is of extraordinary significance, and it fills the gap of clinical evidence of adjuvant targeted therapy for Chinese stage IB patients. For Chinese stage IB patients,this is also the first high-quality evidence that adjuvant targeted therapy has a significant benefit.
Table 1: Comparison of baseline characteristics of ADAURA Chinese cohort and global population< /p>
In addition to the above, the study also reported DFS for each prespecified subgroup RESULTS OF BENEFIT: A trend of benefit from DFS was observed for both.
Among them, 67% of Chinese patients received adjuvant chemotherapy, which is also in line with Chinese guidelines for II/ Treatment recommendations for stage III NSCLC. The significant benefit of this group of people was HR 0.13(95%CI 0.05-0.31), which also means that sequential osimertinib after adjuvant chemotherapy can significantly reduce the The risk of disease recurrence or death is 87%, which is really shocking! Up to now, there is no sequential evidence of adjuvant chemotherapy for the previous generation of EGFR-TKIs, and osimertinib also fills the evidence gap for adjuvant targeted therapy in this part of the Chinese population.
Figure 4: Significant DFS observed in all prespecified subgroups profit trend.
The data is more reliable and the research conclusions are more reliable< /p>
The maturity of research data is complementary to the reliability of data results. We saw an overall maturity of 40% for the primary endpoint of the Chinese cohort study, which provides higher confidence to the trend of the results. But we also see that under the premise of high maturity, the data maturity of the osimertinib group and the control group are 10% and 65%, respectively, and the difference between the two is huge; this also confirms the outstanding performance of osimertinib. Compared with the control group, more patients in the osimertinib group were still in a disease-free state.
At the same time, we also looked at another auxiliary targeting study, EVIDENCE, through its publication According to the calculation of the number of events in the PP population, the maturity of the results of this study is expected to be about 26%. It can be seen that for the Chinese population, the evidence credibility of the ADAURA model will be stronger.
100% Chinese population
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Reviewing the ADAURA study, according to the participating institutions of the registered clinical research queried on the Medical Cube website, in There are 30 sub-centers in China, which are as follows(ranking by website):
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The above centers basically include representative hospitals in the north and south of China, covering a wide range of areas, and the enrolled groups are also very representative.
Summary:
ADAURA China Asia The group demonstrated better efficacy data, and also provided sufficient evidence for Chinese stage IB patients and those who used osimertinib sequentially after adjuvant chemotherapy. Of course, the higher data credibility of the study also guarantees the reliability of the efficacy evidence. Moreover, the study is based on 30 sub-centers and an analysis of 100% Chinese population, and the results have higher reference value and significance for Chinese patients. The third-generation EGFR-TKI osimertinib may really be a gift to the Chinese people, and it is the key to cure for Chinese patients with early and mid-stage non-small cell lung cancer.
References:[1]Wu YL, et al . N Engl J Med. 2020 Oct 29;383(18):1711-1723[2]Wen et al. The Oncologist 2019;24:e1070–1081 span>[3]Zhang et al. Oncotarget 2016; 7: 78985–78993[4]Liang et al. Thorac Cancer 2019; 10:1521–1532 [5]Li et al. Br J Cancer 2014; 110:2812–2820[6]Herbst et al. J Clin Oncol 2020; 38:18_suppl.LBA5[7 ]Wu et al. N Engl J Med 2020;383:1711–1723[8]Majem M, et al.Clin Cancer Res 2022 Jan 10:clincanres
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