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Previous data from IMpower010 (NCT02486718) demonstrated a statistically significant benefit in disease-free survival (DFS) with atezolizumab compared with best supportive care (BSC) in patients with NSCLC resected after platinum-based chemotherapy: PD-L1 tumor cells (TC) ≥ 1% II-IIIA patients (DFS HR=66), II-IIIA patients (DFS HR=79.
Eligible patients had completely resected stage IB (tumor ≥4 cm)-IIIA NSCLC (AJCC/UICC v7) with ECOG PS 0-1. Patients received 1-4 21-day cycles of cisplatin-based doublet chemotherapy (enrollment phase) and were subsequently randomized 1:1 to receive 16 cycles of adjuvant atezolizumab 1200 mg q3w or BSC (randomization phase) .
At the clinical cutoff date (April 18, 2022), with a median follow-up of 45 months, 20% of patients died (ITT population; N = 1005.
Grade 3-4 adverse events (AEs) occurred in 20% and 15% of patients in the atezolizumab and BSC groups, respectively, and grade 5 AEs occurred in 8% and 0%, respectivel.
The results showed that at the first interim analysis of OS, a trend towards OS benefit was observed in the atezolizumab group in patients with stage II-IIIA PD-L1 TC ≥1%, and in patients with PD-L1 TC ≥50% II- In stage IIIA patients, adjuvant atezolizumab showed a clinically meaningful OS benefit (HR=43.
The interim OS analysis data of the IMpower010 study published this time successfully demonstrated that the DFS benefit was transformed into a long-term OS benefit, further confirming that atezolizumab adjuvant therapy is the current new standard for adjuvant therap.
Original source:
PL009 - IMpower010: Overall Survival Interim Analysis of a Phase III Study of Atezolizumab vs Best Supportive Care in Resected NSCL.