Phase III, Randomized Study of Atezolizumab Plus Bevacizumab and Chemotherapy in Patients With EGFR- or ALK-Rearranged or Translocated Non–Small-Cell Lung Cancer (ATTLAS, KCSG-LU19-04)
Atezolizumab
DOI:
10.1200/jco.23.01891
Publication Date:
2023-10-20T15:10:13Z
AUTHORS (24)
ABSTRACT
PURPOSE In the treatment of non–small-cell lung cancer (NSCLC) with a driver mutation, role anti–PD-(L)1 antibody after tyrosine kinase inhibitor (TKI) remains unclear. This randomized, open-label, multicenter, phase III study evaluates efficacy atezolizumab plus bevacizumab, paclitaxel, and carboplatin (ABCP ) in EGFR- or ALK-rearranged translocated NSCLC upon progression on TKI therapy. MATERIALS AND METHODS We compared clinical ABCP followed by maintenance therapy bevacizumab pemetrexed cisplatin (PC) maintenance. The primary end point was progression-free survival (PFS). RESULTS A total 228 patients activating EGFR mutation (n = 215) ALK translocation 13) were enrolled from 16 sites Republic Korea randomly assigned at 2:1 ratio to either 154) PC arm 74). median follow-up duration 26.1 months (95% CI, 24.7 28.2). Objective response rates (69.5% v 41.9%, P < .001) PFS (8.48 5.62 months, hazard [HR], 0.62 [95% 0.45 0.86]; .004) significantly better than arm. benefit increased as PD-L1 expression increased, an HR 0.47, 0.41, 0.24 for ≥1%, ≥10%, ≥50%, respectively. Overall similar between (20.63 20.27 HR, 1.01 0.69 1.46]; .975). safety profile comparable that previously reported, no additional signals, but higher treatment-related adverse events observed CONCLUSION To our knowledge, this is first randomized demonstrate anti–PD-L1 combination chemotherapy who have progressed relevant targeted
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