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Non-small cell lung cancer ( NSCLC ) is a highly malignant tumor, and surgical resection is the treatment of choice for early and partially locally advanced NSCLC
.
However, NSCLC is highly heterogeneous, with large differences in survival among patients, and is prone to local recurrence and distant metastasis after surgery, requiring postoperative adjuvant therapy
lung cancer NSCLC immunity
The IMpower 010 study enrolled patients with completely resected stage IB (≥4 cm)-IIIA NSCLC [using the 7th edition of the Lung Cancer Staging System jointly published by the International Union Against Cancer (UICC) and the American Federation of Cancer (AJCC)], enrolled patients All received 1-4 rounds of platinum-containing adjuvant chemotherapy, and were randomized 1:1 to receive 16 cycles of atezolizumab 1200 mg Q3W or BSC
.
IMpower010 is a randomized, open-label, global, multicenter Phase III study of 1280 patients with stage II-IIIA NSCLC who underwent complete resection and adjuvant chemotherapy to compare atezolizumab with best supportive care (BSC) efficacy and safety
.
Figure 2 IMpower010 research design
Figure 2 IMpower010 Research Design Research DesignIMpower 010 Baseline Characteristics
DFS was significantly better in the atezolizumab group than in the BSC group in the PD-L1 TC ≥1% stage II-IIIA population and in all randomized stage II-IIIA populations; in the ITT population, there was no significant difference in DFS statistical significance
.
In the PD-L1 TC ≥1% stage II-IIIA population, DFS HR=0.
66 (0.
49-0.
87, p=0.
004), and almost all subgroups can benefit from atezolizumab treatment
.
Based on this study, on March 16, 2022, NMPA officially approved atezolizumab as a single agent for PD-L1 positive (TC≥1%), stage II-IIIA after surgical resection and platinum-based chemotherapy The adjuvant therapy for NSCLC patients is the first and only indication of adjuvant immunotherapy after NSCLC surgery approved in China
.
RESULTS: In all stage II-IIIA populations, atezolizumab significantly improved disease-free survival compared with BSC (DFS, 42.
3 months vs 35.
3 months) with a hazard ratio (HR) of 0.
79 (P=0.
02)
.
The 3-year DFS rates in the two groups were 55.
Figure 3 Results of the primary endpoint of the IMpower010 study (all randomized patients)
Figure 3 Results of the primary endpoint of the IMpower010 study (all randomized patients)
In stage II-IIIA patients with PD-L1 ≥1%, the median DFS of the atezolizumab group was significantly better than that of the BSC group (not reached [NE] vs 35.
3 months), and the risk of recurrence was significantly reduced by 34% (HR 0.
66, P=0.
004)
.
The 3-year DFS rates in the two groups were 60.
Figure 4 Results of the primary endpoint of the IMpower010 study (patients with PD-L1 TC ≥ 1%)
Figure 4 Results of the primary endpoint of the IMpower010 study (patients with PD-L1 TC ≥ 1%)
In the subgroup analysis of the stage II-IIIA population with PD-L1 TC ≥1%, the vast majority of subgroups benefited significantly
.
In addition, subgroup analysis of all randomized stage II-IIIA patients showed that PD-L1 level was associated with the benefit of DFS, and the higher the PD-L1 level, the more significant the benefit was
Phase 3 Neoadjuvant PD-(L)1 IO Trial
Phase 3 adjuvant PD-(L)1 IO trial
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