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

Autor: 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, N. Gopalakrishna Iyer
Rok vydání: 2023
Předmět:
Zdroj: Nature Communications. 14
ISSN: 2041-1723
Popis: 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 (
Databáze: OpenAIRE