TY - JOUR
T1 - Overall Survival by Response to First-line Induction Treatment with Atezolizumab plus Platinum-based Chemotherapy or Placebo plus Platinum-based Chemotherapy for Metastatic Urothelial Carcinoma
AU - Grande, Enrique
AU - Bamias, Aristotelis
AU - Galsky, Matthew D.
AU - Kikuchi, Eiji
AU - Davis, Ian D.
AU - Arranz, José Ángel
AU - Rezazadeh Kalebasty, Arash
AU - Garcia del Muro, Xavier
AU - Park, Se Hoon
AU - De Giorgi, Ugo
AU - Alekseev, Boris
AU - Mencinger, Marina
AU - Izumi, Kouji
AU - Puente, Javier
AU - Li, Jian Ri
AU - Bernhard, Sandrine
AU - Nicholas, Alan
AU - Telliez, Julie
AU - De Santis, Maria
N1 - Funding Information:
Funding/Support and role of the sponsor: This study was sponsored by F. Hoffmann-La Roche Ltd. The sponsor was involved in the design and conduct of the study; management, analysis, and interpretation of the data; and preparation, review, and approval of the manuscript.
Funding Information:
Acknowledgements: We thank the patients and their families. We also thank Qian Zhu for contributions to the statistical analyses. This study was sponsored by F. Hoffmann-La Roche. Medical writing assistance was provided by Marcia Gamboa, PhD, of Health Interactions and funded by F. Hoffmann-La Roche. Ian D. Davis is supported in part by an Australian National Health and Medical Research Council Investigator Grant (2016274).
Publisher Copyright:
© 2023 The Authors
PY - 2023/12
Y1 - 2023/12
N2 - Standard-of-care first-line treatment for metastatic urothelial carcinoma (mUC) is platinum-based chemotherapy (CTx). Maintenance immunotherapy is a treatment option for patients without progressive disease (PD) after induction CTx. IMvigor130 was a randomised, phase 3 study evaluating atezolizumab plus platinum-based CTx (arm A), atezolizumab monotherapy (arm B), or placebo plus platinum-based CTx (arm C) as first-line treatment for mUC. The primary progression-free survival (PFS) analysis showed a statistically significant PFS benefit favouring arm A versus arm C, which did not translate into overall survival (OS) benefit at the final OS analysis. We report exploratory analyses based on response to combination induction treatment (arm A vs arm C) using final OS data. Post-induction OS was analysed for patients without PD during induction (4–6 CTx cycles) who received at least one dose of single-agent atezolizumab/placebo maintenance treatment. Post-progression OS was analysed for patients with PD during induction CTx. Addition of atezolizumab to CTx did not impact OS outcomes, regardless of response to induction CTx, with hazard ratios of 0.84 (95% confidence interval [CI] 0.63–1.10) for patients without PD and 0.75 (95% CI 0.54–1.05) for those with PD during induction CTx. Treatment effects appeared to be greatest for patients treated with cisplatin and for those with PD-L1–high tumours. Patient summary: The IMvigor130 trial showed that addition of atezolizumab to chemotherapy (CTx) did not improve survival over CTx alone in patients with bladder cancer. Overall, patients whose cancer did not progress during initial treatment tended to live longer than patients whose cancer did progress, but addition of atezolizumab to CTx did not help either group live longer in comparison to CTx alone. However, the results suggest that patients who received a certain CTx drug (cisplatin) or who had high levels of a marker called PD-L1 in their tumour may get the most improvement from addition of atezolizumab to CTx. The IMvigor130 trial is registered on ClinicalTrials.gov as NCT02807636.
AB - Standard-of-care first-line treatment for metastatic urothelial carcinoma (mUC) is platinum-based chemotherapy (CTx). Maintenance immunotherapy is a treatment option for patients without progressive disease (PD) after induction CTx. IMvigor130 was a randomised, phase 3 study evaluating atezolizumab plus platinum-based CTx (arm A), atezolizumab monotherapy (arm B), or placebo plus platinum-based CTx (arm C) as first-line treatment for mUC. The primary progression-free survival (PFS) analysis showed a statistically significant PFS benefit favouring arm A versus arm C, which did not translate into overall survival (OS) benefit at the final OS analysis. We report exploratory analyses based on response to combination induction treatment (arm A vs arm C) using final OS data. Post-induction OS was analysed for patients without PD during induction (4–6 CTx cycles) who received at least one dose of single-agent atezolizumab/placebo maintenance treatment. Post-progression OS was analysed for patients with PD during induction CTx. Addition of atezolizumab to CTx did not impact OS outcomes, regardless of response to induction CTx, with hazard ratios of 0.84 (95% confidence interval [CI] 0.63–1.10) for patients without PD and 0.75 (95% CI 0.54–1.05) for those with PD during induction CTx. Treatment effects appeared to be greatest for patients treated with cisplatin and for those with PD-L1–high tumours. Patient summary: The IMvigor130 trial showed that addition of atezolizumab to chemotherapy (CTx) did not improve survival over CTx alone in patients with bladder cancer. Overall, patients whose cancer did not progress during initial treatment tended to live longer than patients whose cancer did progress, but addition of atezolizumab to CTx did not help either group live longer in comparison to CTx alone. However, the results suggest that patients who received a certain CTx drug (cisplatin) or who had high levels of a marker called PD-L1 in their tumour may get the most improvement from addition of atezolizumab to CTx. The IMvigor130 trial is registered on ClinicalTrials.gov as NCT02807636.
KW - Atezolizumab
KW - Cancer immunotherapy
KW - First line
KW - IMvigor130
KW - Induction chemotherapy
KW - Maintenance treatment
KW - Metastatic urothelial carcinoma
KW - Overall survival final analysis
KW - Platinum/gemcitabine
KW - Randomised phase 3 study
UR - http://www.scopus.com/inward/record.url?scp=85176280947&partnerID=8YFLogxK
U2 - 10.1016/j.euros.2023.10.002
DO - 10.1016/j.euros.2023.10.002
M3 - Letter
AN - SCOPUS:85176280947
SN - 2666-1691
VL - 58
SP - 28
EP - 36
JO - European Urology Open Science
JF - European Urology Open Science
ER -