Atezolizumab (atezo) monotherapy versus chemotherapy in previously untreated locally advanced or metastatic urothelial carcinoma (mUC): Clinical outcomes by PD-L1 status in cisplatin (cis)-ineligible pts from the phase III IMvigor130 study
| Autor: | Almut Mecke, Enrique Grande, Javier Puente, Matthew D. Galsky, Romain Banchereau, Marina Mencinger, Boris Alekseev, Sanjeev Mariathasan, Eiji Kikuchi, Xinhui Huang, Aristotelis Bamias, Jose Angel Arranz Arija, Kouji Izumi, Ugo De Giorgi, Jian-Ri Li, Xavier Garcia del Muro, Ian D. Davis, Se Hoon Park, Maria De Santis, Chooi Peng Lee |
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| Rok vydání: | 2021 |
| Předmět: |
Cisplatin
Oncology Cancer Research medicine.medical_specialty Chemotherapy Metastatic Urothelial Carcinoma biology business.industry medicine.medical_treatment Locally advanced 03 medical and health sciences 0302 clinical medicine Immune system Atezolizumab 030220 oncology & carcinogenesis Internal medicine PD-L1 medicine biology.protein business 030215 immunology medicine.drug |
| Zdroj: | Journal of Clinical Oncology. 39:434-434 |
| ISSN: | 1527-7755 0732-183X |
| DOI: | 10.1200/jco.2021.39.6_suppl.434 |
| Popis: | 434 Background: Atezo (anti–PD-L1) monotherapy is approved for cis-ineligible pts who have locally advanced or mUC with PD-L1–expressing immune cells on ≥ 5% of the tumor area (IC2/3 per VENTANA SP142 IHC assay). The IMvigor130 primary analysis demonstrated a significant PFS benefit with atezo + platinum/gemcitabine (plt/gem) (arm A) vs placebo (pbo) + plt/gem (arm C) as 1L treatment for mUC (Galsky Lancet 2020); at that time, interim OS data for arm A vs C were encouraging but immature. OS with atezo monotherapy (arm B) could not be formally tested, but favorable efficacy was seen in IC2/3 pts. In this exploratory analysis, we assess outcomes by PD-L1 status in cis-ineligible pts. Methods: Pts were randomized 1:1:1 to arms A, B or C (Galsky Lancet 2020). Evaluation of OS (co-primary EP) was performed via a hierarchical fixed sequence procedure: arm A vs C ITT pts; then, arm B vs C ITT and IC2/3 pts. No formal testing was performed in this exploratory subgroup analyses; OS and RECIST 1.1 ORR (per investigator [secondary EP]) were descriptively evaluated. Results: Efficacy data suggested OS and ORR benefit in atezo-treated cis-ineligible IC2/3 pts (Table). In the overall safety population, all-grade treatment-related AEs (TRAEs) had occurred in 60% and 96% of arm B and C pts, respectively; grade 3-4 TRAEs occurred in 15% and 81%, respectively. Biomarker data evaluating PD-L1 biology (assessed by SP142) and associated transcriptome analysis in arms B vs C will be presented. Conclusions: This exploratory analysis of IMvigor130 pts with 1L cis–ineligible IC2/3 mUC provides additional evidence for clinical benefit with single-agent atezo, a well-tolerated treatment with a distinct safety profile vs chemo. Analyses with longer OS follow-up are warranted. Clinical trial information: NCT02807636 . Research Sponsor: F. Hoffmann-La Roche Ltd[Table: see text] |
| Databáze: | OpenAIRE |
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