Abstract
LB005/#1605 Randomized, phase II/III study of pegylated liposomal doxorubicin, bevacizumab, and atezolizumab in platinum-resistant ovarian cancer (NRG-GY009): clinical outcomes by PD-L1 and T cell infiltration status
International journal of gynecological cancer, Vol.34(SUPPL_3), pp.A10-A10
10/2024
DOI: 10.1136/ijgc-2024-IGCS.10
Abstract
Introduction
NRG-GY009 was a randomized clinical trial of pegylated liposomal doxorubicin (PLD), bevacizumab (BEV), and atezolizumab (ATEZO) and PLD/ATEZO compared to PLD/BEV in patients with platinum-resistant ovarian cancer (PROC) (n=444). Addition of ATEZO to PLD/BEV did not result in a statistically significant prolongation of progression-free survival or overall survival (OS). Here, we present interaction/subgroup analyses by baseline tumor PD-L1 expression and tumor infiltrating lymphocyte (TIL) status.
Methods
Archival tumor samples were analyzed for immune cell PD-L1 and CD8 infiltration using Ventana SP142 and CD8 IHC assays, respectively. Outcomes were examined by PD-L1 status using 5% or 1% as cutoffs, CD8 status using quartiles, and TIL status using tertiles. Log-rank and Cox models were used to assess the relationships between the individual biomarkers and PFS/OS.
Results
Baseline tissue was analyzed from PLD/BEV/ATEZO (n=131), PLD/ATEZO (n=105), and PLD/BEV (n=134) patients, yielding PD-L1≥5% and PD-L1≥1% in 45 and 169 patients, respectively. Patients in the PD-L1<1% group who received PLD/BEV/ATEZO exhibited prolonged PFS (HR 0.55, 95% CI 0.391-0.784) and OS (HR 0.66, 95% CI 0.458-0.940) when compared to PLD/BEV. No significant differences were noted between the treatment arms in the PD-L1≥1% group. When examining CD8+ T cell TIL status, no significant associations were observed between the presence of immune cells and clinical outcomes.
Conclusion/Implications
In this exploratory analysis, patients with PD-L1<1% tumors demonstrated improved PFS/OS when treated with PLD/BEV/ATEZO when compared to PLD/BEV, highlighting the unreliability of PD-L1 as a biomarker in PROC. Identification of immune biomarkers relevant to PROC remains an unmet need.
Details
- Title: Subtitle
- LB005/#1605 Randomized, phase II/III study of pegylated liposomal doxorubicin, bevacizumab, and atezolizumab in platinum-resistant ovarian cancer (NRG-GY009): clinical outcomes by PD-L1 and T cell infiltration status
- Creators
- Roisin O’Cearbhaill - Memorial Sloan Kettering Cancer CenterDmitriy Zamarin - Icahn School of Medicine at Mount SinaiMichael Sill - Roswell Park Comprehensive Cancer CenterHoa Duong - Kaiser PermanenteSteven Waggoner - Case Comprehensive Cancer CenterRachel Grisham - Memorial Sloan Kettering Cancer CenterFloor Backes - The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research InstituteRobert Mannel - University of Oklahoma Health Sciences CenterJanos Tanyi - University of PennsylvaniaMatthew Powell - Washington University in St. LouisCara Mathews - Women & Infants Hospital of Rhode IslandSharad Ghamande - Augusta UniversityLeah McNally - Duke Cancer InstituteAlexander Olawaiye - University of Pittsburgh Medical CenterDavid Bender - University of IowaLinda Duska - University of AmsterdamHeather Lankes - The Ohio State University Wexner Medical CenterRussell Schilder - Thomas Jefferson UniversityMichael Bookman - Kaiser PermanenteCarol Aghajanian - Memorial Sloan Kettering Cancer Center
- Resource Type
- Abstract
- Publication Details
- International journal of gynecological cancer, Vol.34(SUPPL_3), pp.A10-A10
- DOI
- 10.1136/ijgc-2024-IGCS.10
- ISSN
- 1048-891X
- eISSN
- 1525-1438
- Publisher
- Elsevier Inc
- Language
- English
- Date published
- 10/2024
- Academic Unit
- Obstetrics and Gynecology
- Record Identifier
- 9984759889002771
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