TY  - JOUR
AU  - Fayette, Jérôme
AU  - Licitra, Lisa
AU  - Harrington, Kevin
AU  - Haddad, Robert
AU  - Siu, Lillian L
AU  - Liu, Yi-Chun
AU  - Tahara, Makoto
AU  - Machiels, Jean-Pascal
AU  - Rischin, Danny
AU  - Seiwert, Tanguy Y
AU  - Ferris, Robert L
AU  - Keilholz, Ulrich
AU  - Psyrri, Amanda
AU  - Keam, Bhumsuk
AU  - Bossi, Paolo
AU  - Metcalf, Robert
AU  - Hsieh, Ching-Yun
AU  - Clement, Paul M J
AU  - Isaev, Pavel
AU  - Mudunov, Ali
AU  - Dinis, José
AU  - Hoeben, Ann
AU  - Kasper, Stefan
AU  - Klinghammer, Konrad
AU  - Hwang, Michael
AU  - Blando, Jorge
AU  - Serrano, Olivier
AU  - Ruscica, Dario
AU  - Cohen, Roger B
TI  - INTERLINK-1: A Phase III, Randomized, Placebo-Controlled Study of Monalizumab Plus Cetuximab in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma.
JO  - Clinical cancer research
VL  - 31
IS  - 13
SN  - 1078-0432
CY  - Philadelphia, Pa. [u.a.]
PB  - AACR
M1  - DKFZ-2025-00929
SP  - 2617-2627
PY  - 2025
N1  - 2025 Jul 1;31(13):2617-2627
AB  - 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
LB  - PUB:(DE-HGF)16
C6  - pmid:40300079
DO  - DOI:10.1158/1078-0432.CCR-25-0073
UR  - https://inrepo02.dkfz.de/record/300815
ER  -