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@ARTICLE{Fayette:300815,
      author       = {J. Fayette and L. Licitra and K. Harrington and R. Haddad
                      and L. L. Siu and Y.-C. Liu and M. Tahara and J.-P. Machiels
                      and D. Rischin and T. Y. Seiwert and R. L. Ferris and U.
                      Keilholz and A. Psyrri and B. Keam and P. Bossi and R.
                      Metcalf and C.-Y. Hsieh and P. M. J. Clement and P. Isaev
                      and A. Mudunov and J. Dinis and A. Hoeben and S. Kasper$^*$
                      and K. Klinghammer and M. Hwang and J. Blando and O. Serrano
                      and D. Ruscica and R. B. Cohen},
      title        = {{INTERLINK}-1: {A} {P}hase {III}, {R}andomized,
                      {P}lacebo-{C}ontrolled {S}tudy of {M}onalizumab {P}lus
                      {C}etuximab in {R}ecurrent/{M}etastatic {H}ead and {N}eck
                      {S}quamous {C}ell {C}arcinoma.},
      journal      = {Clinical cancer research},
      volume       = {31},
      number       = {13},
      issn         = {1078-0432},
      address      = {Philadelphia, Pa. [u.a.]},
      publisher    = {AACR},
      reportid     = {DKFZ-2025-00929},
      pages        = {2617-2627},
      year         = {2025},
      note         = {2025 Jul 1;31(13):2617-2627},
      abstract     = {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; $95\%$
                      CI, 0.66-1.54); median PFS was 3.6 versus 3.8 months,
                      respectively (HR, 1.11; $95\%$ CI, 0.79-1.57); and ORR was
                      $15.2\%$ versus $23.9\%,$ respectively. INTERLINK-1 was
                      terminated after a preplanned interim analysis showed
                      futility criteria were met (predetermined futility HR
                      >0.874). Grade 3-4 treatment-related adverse events were
                      reported in $18.3\%$ and $17.2\%$ of participants treated in
                      the monalizumab and placebo arms, respectively.Monalizumab
                      plus cetuximab did not improve OS compared with placebo plus
                      cetuximab. The safety profile of the combination was
                      consistent with safety observations for cetuximab
                      monotherapy.},
      cin          = {ED01},
      ddc          = {610},
      cid          = {I:(DE-He78)ED01-20160331},
      pnm          = {899 - ohne Topic (POF4-899)},
      pid          = {G:(DE-HGF)POF4-899},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:40300079},
      doi          = {10.1158/1078-0432.CCR-25-0073},
      url          = {https://inrepo02.dkfz.de/record/300815},
}