An open-label, multicohort, phase I/II study to evaluate nivolumab in patients with virus-associated tumors (CheckMate 358): Efficacy and safety in recurrent or metastatic (R/M) nasopharyngeal carcinoma (NPC).

• DOI: 10.1200/jco.2017.35.15_suppl.6025
• Publication Date: 2018-09-06T15:47:30Z
• Authors: Jean-Pierre Delord; Antoine Hollebecque; J. P. De Boer; Jacques De Greve; Jean-Pascal H. Ma...; Rom S. Leidner; Robert L. Ferris; Shangbang Rao; Ibrahima Soumaoro; Z. Alexander Cao; Hyunseok Kang; Suzanne Louise To...
• Keywords: Clinical endpoint; Progression-free survival

6025 Background: Treatment options for patients (pts) with R/M NPC are limited to palliative chemotherapy. is often associated the Epstein–Barr virus (EBV), a potential antigen immune recognition, and high expression levels of checkpoint receptor programmed death-1 (PD-1) its major ligand PD-L1. Nivolumab disrupts PD-1–mediated signaling, restoring T-cell antitumor function. Methods: In CheckMate 358 (NCT02488759), PD-L1–unselected adults NPC, ECOG PS 0–1, ≤2 prior systemic therapies in setting were eligible receive nivolumab 240 mg every 2 weeks until progression or unacceptable toxicity, as part an ongoing multicohort study 5 virus-associated cancers. Human papillomavirus-associated keratinizing squamous cell carcinoma (WHO Type 1) excluded. Primary endpoints objective response rate (ORR) safety; secondary duration (DoR), progression-free survival (PFS), overall (OS). Results: Of 24 treated pts median age was 51 years, 88% male, 62% white, European, had EBV+ tumors. At follow-up 26 (range: 4–40), ORR 20.8% appeared be higher no therapy (Table). The disease control (ORR + SD) 45.8%. Responses observed regardless PD-L1 EBV status. Median PFS 2.4 mo (95% CI: 1.5, NR); OS NR. Conclusions: demonstrated clinical activity manageable safety profile supporting research this disease. Updated efficacy biomarker data will presented. Clinical trial information: NCT02488759. [Table: see text]