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1 Avelumab in combination with and/or following chemotherapy vs chemotherapy in treatment-naive patients with ovarian cancer: biomarker analyses from the phase 3 JAVELIN Ovarian 100 trial
  1. J Ledermann1,
  2. N Colombo2,
  3. A Oza3,
  4. K Fujiwara4,
  5. MJ Birrer5,
  6. L Randall6,
  7. E Poddubskaya7,
  8. G Scambia8,
  9. YV Shparyk9,
  10. MC Lim10,
  11. MC Lim11,
  12. J Sohn12,
  13. K Yonemori13,
  14. RA Stewart14,
  15. X Zhang14,
  16. J Perkins Smith14,
  17. C Linn15 and
  18. BJ Monk16
  1. 1UCL Cancer Institute and UCL Hospitals NHS Foundation Trust, UK
  2. 2University of Milan-Bicocca and Istituto Europeo di Oncologia, IRCCS, Italy
  3. 3Princess Margaret Cancer Centre, Canada
  4. 4Saitama Medical University International Medical Center, Japan
  5. 5O’Neal Comprehensive Cancer Center, The University of Alabama at Birmingham, USA
  6. 6Virginia Commonwealth University, Massey Cancer Center, USA
  7. 7I.M. Sechenov First Moscow State Medical University and Clinical Center Vitamed, Russia
  8. 8Gynecologic Oncology Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Italy
  9. 9Lviv State Oncological Regional Treatment and Diagnostic Center, Ukraine
  10. 10Research Institute and Hospital, National Cancer Center, South Korea
  11. 11Arizona Oncology Associates, PC – HAL, USA
  12. 12Severance Hospital, Yonsei University Health System, South Korea
  13. 13Department of Breast and Medical Oncology, National Cancer Center Hospital, Japan
  14. 14Pfizer Oncology, Pfizer Inc, USA
  15. 15Global Product Development, Pfizer Inc, Taiwan
  16. 16Arizona Oncology (US Oncology Network), University of Arizona and Creighton University, USA


Introduction In the JAVELIN Ovarian 100 trial (NCT02718417), avelumab (anti–PD-L1) in combination with chemotherapy or as maintenance did not improve progression-free survival (PFS) vs chemotherapy followed by observation in treatment-naive patients with epithelial ovarian cancer (EOC; hazard ratios [95% CI] were 1.14 [0.832, 1.565] and 1.43 [1.051, 1.946], respectively). The trial was terminated when prespecified futility boundaries were crossed at the interim analysis, and study treatment was subsequently discontinued. Here we report biomarker analyses.

Methods Women with stage III-IV EOC (post debulking/cytoreductive surgery or candidates for neoadjuvant chemotherapy) were randomized 1:1:1 to receive carboplatin/paclitaxel chemotherapy (6 cycles) followed by avelumab every 2 weeks as maintenance (CTx→Ave), chemotherapy + avelumab (10 mg/kg every 3 weeks) followed by avelumab every 2 weeks as maintenance (CTx+Ave→Ave), or chemotherapy followed by observation (CTx→O; control arm). The primary endpoint was PFS by blinded independent central review per RECIST version 1.1. Pretreatment tumor tissue was analyzed by immunohistochemistry (CD8 and PD-L1) and next-generation DNA and RNA sequencing.

Results 998 patients were randomized. Subgroup analyses based on PD-L1, CD8, and germline BRCA1/2 status did not identify subsets with clear PFS benefit in either avelumab arm vs control (table 1). Whole-exome and RNA sequencing analyses will be presented.

Abstract 1 Table 1

Conclusions In the JAVELIN Ovarian 100 trial, PD-L1, CD8, and germline BRCA1/2 status did not predict differential clinical benefit with the addition of avelumab to chemotherapy in treatment-naive patients with EOC.

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