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Osimertinib granted FDA BTD for adjuvant treatment of resectable, EGFRmut NSCLC

ADAURA compared adjuvant osimertinib to placebo as adjuvant therapy in EGFRmut NSCLC (stage IB/II/IIIA). The trial design allowed for adjuvant chemotherapy before initiating osimertinib.

The data, presented at ASCO 2020, showed an impressive improvement in 2-yr DFS for pts with stage II/IIIa disease (primary endpoint): HR: 0.17, P<.0001. Benefit in the stage IB subset was less pronounced (HR: 0.50; 95% CI: 0.25-0.96); even so, this subset was included in the FDA BTD.

ADAURA build on earlier studies with 1st generation TKIs erlotinib and gefitinib as adjuvant therapy in resected, EGFRmut NSCLC. Specifically, The Chinese CTONG1104 study showed a significant DFS benefit with gefitinib vs platinum-based chemotherapy in stage II/IIIa disease (HR: 0.60; P=.005).

Osimertinib will be the first, and likely only, EGFR TKI to be approved in the adjuvant setting; FDA approval can be expected as early as 4Q 2020

ADAURA: NCT02511106
Herbst et al., ASCO 2020: LBA5
Zhong et al., Lancet Oncol. 2018 (PMID: 29174310)