PT  - JOURNAL ARTICLE
AU  - Ledermann, J
AU  - Colombo, N
AU  - Oza, A
AU  - Fujiwara, K
AU  - Birrer, MJ
AU  - Randall, L
AU  - Poddubskaya, E
AU  - Scambia, G
AU  - Shparyk, YV
AU  - Lim, MC
AU  - Lim, MC
AU  - Sohn, J
AU  - Yonemori, K
AU  - Stewart, RA
AU  - Zhang, X
AU  - Perkins Smith, J
AU  - Linn, C
AU  - Monk, BJ
TI  - 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
AID  - 10.1136/ijgc-2020-IGCS.1
DP  - 2020 Nov 01
TA  - International Journal of Gynecologic Cancer
PG  - A1--A1
VI  - 30
IP  - Suppl 3
4099  - http://ijgc.bmj.com/content/30/Suppl_3/A1.1.short
4100  - http://ijgc.bmj.com/content/30/Suppl_3/A1.1.full
SO  - Int J Gynecol Cancer2020 Nov 01; 30
AB  - 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.View this table: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.