Clinical efficacy and biomarker analysis of dual PD-1/CTLA-4 blockade in recurrent/metastatic EBV-associated nasopharyngeal carcinoma

Darren Wan-Teck Lim (), Hsiang-Fong Kao, Lisda Suteja, Constance H. Li, Hong Sheng Quah, Daniel Shao-Weng Tan, Sze-Huey Tan, Eng-Huat Tan, Wan-Ling Tan, Justina Nadia Lee, Felicia Yu-Ting Wee, Amit Jain, Boon-Cher Goh, Melvin L. K. Chua, Bin-Chi Liao, Quan Sing Ng, Ruey-Long Hong, Mei-Kim Ang, Joe Poh-Sheng Yeong and N. Gopalakrishna Iyer ()
Additional contact information
Darren Wan-Teck Lim: National Cancer Centre Singapore
Hsiang-Fong Kao: National Taiwan University Hospital
Lisda Suteja: National Cancer Centre Singapore
Constance H. Li: National Cancer Centre Singapore
Hong Sheng Quah: National Cancer Centre Singapore
Daniel Shao-Weng Tan: National Cancer Centre Singapore
Sze-Huey Tan: National Cancer Centre Singapore
Eng-Huat Tan: National Cancer Centre Singapore
Wan-Ling Tan: National Cancer Centre Singapore
Justina Nadia Lee: Institute of Molecular and Cell Biology, A*STAR
Felicia Yu-Ting Wee: Institute of Molecular and Cell Biology, A*STAR
Amit Jain: National Cancer Centre Singapore
Boon-Cher Goh: National University Health System
Melvin L. K. Chua: National Cancer Centre Singapore
Bin-Chi Liao: National Taiwan University Hospital
Quan Sing Ng: National Cancer Centre Singapore
Ruey-Long Hong: National Taiwan University Hospital
Mei-Kim Ang: National Cancer Centre Singapore
Joe Poh-Sheng Yeong: Institute of Molecular and Cell Biology, A*STAR
N. Gopalakrishna Iyer: National Cancer Centre Singapore

Nature Communications, 2023, vol. 14, issue 1, 1-12

Abstract: Abstract Single-agent checkpoint inhibitor (CPI) activity in Epstein-Barr Virus (EBV) related nasopharyngeal carcinoma (NPC) is limited. Dual CPI shows increased activity in solid cancers. In this single-arm phase II trial (NCT03097939), 40 patients with recurrent/metastatic EBV-positive NPC who failed prior chemotherapy receive nivolumab 3 mg/kg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks. Primary outcome of best overall response rate (BOR) and secondary outcomes (progression-free survival [PFS], clinical benefit rate, adverse events, duration of response, time to progression, overall survival [OS]) are reported. The BOR is 38% with median PFS and OS of 5.3 and 19.5 months, respectively. This regimen is well-tolerated and treatment-related adverse events requiring discontinuation are low. Biomarker analysis shows no correlation of outcomes to PD-L1 expression or tumor mutation burden. While the BOR does not meet pre-planned estimates, patients with low plasma EBV-DNA titre (

Date: 2023
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DOI: 10.1038/s41467-023-38407-7

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