The Phase 3 IMpower010 trial (NCT02486718) for atezolizumab reached primary completion on 2024-01-26, with results indicating improved disease-free survival (DFS) in patients with non-small cell lung cancer (NSCLC). In the intent-to-treat (ITT) population, atezolizumab demonstrated a median DFS of 65.6 months compared to 47.8 months for best supportive care.

Background

This study investigated atezolizumab as an adjuvant treatment for participants with Stage IB-Stage IIIA non-small cell lung cancer (NSCLC) following resection and adjuvant chemotherapy.

Trial design

The Phase 3, global, multicenter, open-label, randomized IMpower010 study (NCT02486718) enrolled 1280 participants with Stage IB-Stage IIIA non-small cell lung cancer (NSCLC) following resection and adjuvant chemotherapy. Participants were randomized 1:1 to receive either atezolizumab for 16 cycles or best supportive care (BSC) after completing up to 4 cycles of adjuvant cisplatin-based chemotherapy, which could include cisplatin with vinorelbine, docetaxel, or gemcitabine. The primary endpoints were disease-free survival (DFS) as assessed by the investigator and overall survival (OS).

Key results

  • In the intent-to-treat (ITT) population, the median Disease-Free Survival (DFS) was 65.6 months for the atezolizumab arm and 47.8 months for the Best Supportive Care (BSC) arm.
  • For the all randomized Stage II-IIIA population, median DFS was 57.4 months with atezolizumab versus 40.8 months with BSC.
  • In the Programmed Death-ligand 1 (PD-L1) SP263 ≥ 1% Tumor Cell (TC) subpopulation within the Stage II-IIIA population, median DFS was 68.5 months for atezolizumab compared to 37.3 months for BSC.
  • The Disease-free Rate at Year 3 in the ITT population was 61.43 percentage of participants for atezolizumab and 55.45 percentage of participants for BSC.
  • The Disease-free Rate at Year 3 in the all randomized Stage II-IIIA population was 59.30 percentage of participants for atezolizumab and 52.64 percentage of participants for BSC.
  • The Disease-free Rate at Year 3 in the PD-L1 (SP263 ≥ 1% TC) subpopulation within the Stage II-IIIA population was 62.72 percentage of participants for atezolizumab and 52.05 percentage of participants for BSC.

Key analyses included:

  • A Hazard Ratio (HR) of 0.848 (95.0% CI: 0.71 to 1.013) by Log Rank method, with a p-value of 0.0683.
  • A Hazard Ratio (HR) of 0.83 (95.0% CI: 0.691 to 0.998).
  • A Hazard Ratio (HR) of 0.704 (95.0% CI: 0.545 to 0.91).
  • A Difference in event-free rates of 5.98 (95.0% CI: -0.28 to 12.23).
  • A Difference in event-free rates of 6.65 (95.0% CI: -0.06 to 13.36).
  • A Difference in event-free rates of 10.67 (95.0% CI: 1.56 to 19.79).

What this means

The primary completion results from the IMpower010 trial indicate that adjuvant atezolizumab significantly improves disease-free survival in patients with resected Stage IB-IIIA non-small cell lung cancer who have completed chemotherapy. The observed median DFS benefit of 17.8 months in the ITT population (65.6 months vs 47.8 months) and even more pronounced benefit in the PD-L1 positive subgroup (68.5 months vs 37.3 months) suggests a clinically meaningful impact. The hazard ratios further support a reduced risk of disease recurrence or death with atezolizumab treatment, particularly in the PD-L1 positive population, highlighting its potential as a post-adjuvant chemotherapy option for this patient group.

Source

This information was sourced from ClinicalTrials.gov, detailing the primary completion of trial NCT02486718 posted on 2024-01-26. The full study details are available on clinicaltrials.gov.