Effectiveness and safety of Atezolizumab in patients with locally-advanced or metastatic non-small cell lung cancer after prior chemotherapy under real-life conditions in Germany: The Non-interventional Study HYPERION

Science and Research

BACKGROUND: Atezolizumab is the first approved PD-L1 inhibitor for patients with advanced non-small cell lung cancer (NSCLC) in Germany. This study aimed to assess effectiveness and safety of this checkpoint inhibitor in clinical routine practice. In addition, potential correlating factors between patient or disease characteristics and clinical benefit of atezolizumab were addressed. METHODS: HYPERION was a prospective, multicenter, non-interventional, two-cohort study collecting primary data in patients with locally-advanced or metastatic NSCLC after prior chemotherapy treated with atezolizumab. Patients were assigned to one of two cohorts depending on their clinical benefit from atezolizumab, i.e., lack of benefit (Cohort 1) or durability of clinical benefit and tumor response (Cohort 2), as assessed by the physicians. RESULTS: Between May 2018 and August 2023, 353 patients were observed, including 179 in Cohort 1 and 174 in Cohort 2. The median age was 68 years and 61 % were men. The median time to loss of clinical benefit was 106 days (95 % CI: 93, 119) overall (n = 353 patients) and 256 days (95 % CI: 210, 339) for Cohort 2 (n = 174 patients). In total, 243 (68.8 %) patients experienced at least one adverse event (AE) and 146 (41.4 %) patients at least one serious AE. A higher proportion of PD-L1 positive patients was observed for Cohort 2 than for Cohort 1. CONCLUSION: HYPERION confirmed effectiveness of atezolizumab in clinical practice. Results supported a known correlation between PD-L1 expression and a higher benefit of atezolizumab treatment. Atezolizumab treatment was associated with an acceptable safety profile. MICRO ABSTRACT: The two-cohort non-interventional study HYPERION assessed the effectiveness and safety of atezolizumab in 353 patients with locally-advanced or metastatic NSCLC after prior chemotherapy, depending on lack of benefit (Cohort 1; n = 179) or durability of clinical benefit and tumor response (Cohort 2; n = 174). Atezolizumab showed effectiveness in clinical practice. Results were consistent with the known safety profile.