%0 Journal Article
%A Fayette, Jérôme
%A Licitra, Lisa
%A Harrington, Kevin
%A Haddad, Robert
%A Siu, Lillian L
%A Liu, Yi-Chun
%A Tahara, Makoto
%A Machiels, Jean-Pascal
%A Rischin, Danny
%A Seiwert, Tanguy Y
%A Ferris, Robert L
%A Keilholz, Ulrich
%A Psyrri, Amanda
%A Keam, Bhumsuk
%A Bossi, Paolo
%A Metcalf, Robert
%A Hsieh, Ching-Yun
%A Clement, Paul M J
%A Isaev, Pavel
%A Mudunov, Ali
%A Dinis, José
%A Hoeben, Ann
%A Kasper, Stefan
%A Klinghammer, Konrad
%A Hwang, Michael
%A Blando, Jorge
%A Serrano, Olivier
%A Ruscica, Dario
%A Cohen, Roger B
%T INTERLINK-1: A Phase III, Randomized, Placebo-Controlled Study of Monalizumab Plus Cetuximab in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma.
%J Clinical cancer research
%V 31
%N 13
%@ 1078-0432
%C Philadelphia, Pa. [u.a.]
%I AACR
%M DKFZ-2025-00929
%P 2617-2627
%D 2025
%Z 2025 Jul 1;31(13):2617-2627
%X Treatment options for recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) after failure of immune checkpoint inhibitor (ICI) treatment and platinum-based chemotherapy are limited. Preliminary data suggested monalizumab plus cetuximab had clinical activity in R/M HNSCC.INTERLINK-1 (NCT04590963) was a double-blind, phase III study. Participants with R/M HNSCC who had received ICI therapy and progressed despite platinum-based chemotherapy were randomized 2:1 to monalizumab (750 mg, fortnightly) or placebo, plus cetuximab (400 mg/m2 loading dose, then 250 mg/m2, weekly). The primary endpoint was overall survival (OS) in participants with non-oropharyngeal cancer (OPC) or human papillomavirus (HPV)-negative OPC (HPV-unrelated analysis set). Secondary endpoints included progression-free survival (PFS) and objective response rate (ORR).At data cut-off, 216 participants were randomized in the HPV-unrelated analysis set; 145 to monalizumab plus cetuximab and 71 to placebo plus cetuximab. Median OS was 8.8 months for monalizumab plus cetuximab versus 8.6 months for placebo plus cetuximab (hazard ratio [HR], 1.00; 95
%F PUB:(DE-HGF)16
%9 Journal Article
%$ pmid:40300079
%R 10.1158/1078-0432.CCR-25-0073
%U https://inrepo02.dkfz.de/record/300815