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PO005LBA/#1579  A randomized, phase II/III study of pegylated-liposomal-doxorubicin and atezolizumab (IND #134427) versus pegylated-liposomal-doxorubicin, bevacizumab and atezolizumab versus pegylated-liposomal-doxorubicin and bevacizumab in platinum-resistant ovarian cancer (NRG-GY009)
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  1. Roisin O’Cearbhaill1,
  2. Michael Sill2,
  3. Hoa Duong3,
  4. Steven Waggoner4,
  5. Rachel Grisham1,
  6. Floor Backes5,
  7. Robert Mannel6,
  8. Janos Tanyi7,
  9. Matthew Powell8,
  10. Cara Mathews9,
  11. Sharad Ghamande10,
  12. Leah Mcnally11,
  13. Alexander Olawaiye12,
  14. David Bender13,
  15. Linda Duska14,
  16. Heather Lankes15,
  17. Dmitriy Zamarin16,
  18. Russell Schilder17,
  19. Michael Bookman18 and
  20. Carol Aghajanian1
  1. 1Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College, Medicine, New York, USA
  2. 2NRG Oncology Statistics and Data Management Center, Biostatistics and Bioinformatics Department, Buffalo, USA
  3. 3Kaiser-Permanente Sacramento, Hematology/oncology, Sacramento, USA
  4. 4CWRU Case Comprehensive Cancer Center, Gynecologic Oncology, Cleveland, USA
  5. 5Ohio State University Comprehensive Cancer Center, Gynecologic Oncology, Ohio, USA
  6. 6University of Oklahoma Health Sciences Center, Obstetrics and Gynecology, Oklahoma, USA
  7. 7University of Pennsylvania/Abramson Cancer Center, Obstetrics and Gynecology, Philadelphia, USA
  8. 8Washington University, Gynecologic Oncology, St. Louis, USA
  9. 9Women and Infants Hospital, Obstetrics and Gynecology, Providence, USA
  10. 10Georgia Cares Minority Underserved NCORP, Gynecologic Oncology, Augusta, USA
  11. 11Duke Cancer Institute, Gynecologic Oncology, Durham, USA
  12. 12UPMC Hillman Cancer Center, Gynecologic Oncology, Pittsburgh, USA
  13. 13University of Iowa, Obstetrics and Gynecology, Iowa City, USA
  14. 14University of Virginia Cancer Center, Gynecologic Oncology, Charlottesville, USA
  15. 15NRG Oncology Biospecimen Bank-Columbus, Translational Science Operations, Columbus, USA
  16. 16Icahn School of Medicine at Mount Sinai, Hematology/oncology, New York, USA
  17. 17Thomas Jefferson University, Gynecologic Medical Oncology, Philadelphia, USA
  18. 18Kaiser Permanente Northern California, Gynecologic Oncology, San Francisco, USA

Abstract

Introduction In this multicentre randomized, phase II/III trial, we sought to examine if the 1) combination of anti-programmed death ligand 1 (PD-L1) monoclonal antibody atezolizumab (ATEZO) with pegylated-liposomal- doxorubicin (PLD) [Arm 1] and/or 2) addition of ATEZO to PLD and bevacizumab (BEV) [Arm 2] result in an improvement in survival for patients with platinum resistant ovarian cancer (PROC) compared to the standard PLD/BEV [Arm 3].

Methods Patients were randomly assigned 1:1:1 to PLD/ATEZO, PLD/BEV/ATEZO or PLD/BEV (IV PLD 40 mg/m2 q4weeks; BEV 10 mg/kg q2weeks; ATEZO 800 mg q2weeks). Key eligibility: 1–2 prior lines of therapy (no PLD), ECOG 0–2, and RECIST measurable/evaluable PROC. No stratification by PD-L1 status. The phase II primary endpoint was PFS. The phase III coprimary endpoints were PFS/OS.

Results From 05/2017–10/2021 444 patients with PROC were enrolled. The median age was 63 yrs (35–86). All had received prior chemotherapy; 434 (97.7%) prior surgery and 9 (2%) prior biological therapy. At the phase III interim analysis Arm 1 (PLD/ATEZO) was discontinued for futility. The phase III OS/PFS analysis included accruals to Arms 2 (PLD/BEV/ATEZO) and 3 (PLD/BEV) from all phases. With median follow-up of 47 months, median PFS was 7.4 months and 5.6 months (HR 0.79 with 99.99% 1-sided CI 0.0–1.21), and median OS was 14.9 months and 12.3 months (HR 0.80; 98.78% 1-sided CI 0.00–1.06; 1-sided p=0.038) for Arms 2 and 3, respectively. Adverse events were as expected.

Conclusion/Implications The addition of ATEZO to PLD/BEV did not result in a statistically significant longer OS than PLD/BEV in PROC. Subset analysis are planned to evaluate survival outcomes with high PD-L1 expression (NRG-GY009/NCT02839707).

Abstract PO005LBA/#1579 Figure 1
Abstract PO005LBA/#1579 Figure 2

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