2024
Lenvatinib ± Pembrolizumab Versus Chemotherapy for Recurrent/Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) That Progressed after Platinum and Immunotherapy: The Phase 2 LEAP-009 Study
Harrington K, Kim H, Salas S, Oliva M, Metcalf R, Bernsdorf M, Kim J, Cohen E, Siu L, Rischin D, Licitra L, Vermorken J, Le Q, Tahara M, Machiels J, O'Hara K, Pathiraja K, Gumuscu B, Bidadi B, Burtness B. Lenvatinib ± Pembrolizumab Versus Chemotherapy for Recurrent/Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) That Progressed after Platinum and Immunotherapy: The Phase 2 LEAP-009 Study. International Journal Of Radiation Oncology • Biology • Physics 2024, 118: e42. DOI: 10.1016/j.ijrobp.2024.01.095.Peer-Reviewed Original ResearchR/M HNSCCHead and neck squamous cell carcinomaPD-1/L1 inhibitorsPlatinum-based therapyPlatinum-based chemotherapyDisease progressionLenvatinib monotherapyECOG PSRecurrent/metastatic (R/M) head and neck squamous cell carcinomaPD-L1 tumor proportion scoreStandard-of-care chemotherapyNeck squamous cell carcinomaTumor proportion scoreProgression-free survivalDuration of responseEfficacy of lenvatinibSecondary end pointsFirst-line treatmentSquamous cell carcinomaEfficacious treatment optionStandard of careOral lenvatinibPembrolizumab monotherapyRECIST v1.1Monotherapy arm
2017
LUX-head and neck 2: Randomized, double-blind, placebo-controlled, phase III trial of afatinib as adjuvant therapy after chemoradiation (CRT) in primary unresected, high/intermediate-risk, squamous cell cancer of the head and neck (HNSCC) patients (pts).
Burtness B, Haddad R, Dinis J, Trigo Perez J, Yokota T, Viana L, Romanov I, Vermorken J, Bourhis J, Tahara M, Segalla J, Psyrri A, Vasilevskaya I, Nangia C, Chaves-Conde M, Wang B, Gibson N, Ehrnrooth E, Harrington K, Cohen E. LUX-head and neck 2: Randomized, double-blind, placebo-controlled, phase III trial of afatinib as adjuvant therapy after chemoradiation (CRT) in primary unresected, high/intermediate-risk, squamous cell cancer of the head and neck (HNSCC) patients (pts). Journal Of Clinical Oncology 2017, 35: 6001-6001. DOI: 10.1200/jco.2017.35.15_suppl.6001.Peer-Reviewed Original ResearchDisease-free survivalPhase III trialsIII trialsEGFR inhibitionMedian disease-free survivalRecurrent/metastatic diseaseErbB family blocker afatinibPre-planned interim analysisECOG PS 0Median treatment durationSquamous cell cancerDefinitive chemoradiationECOG PSEligible ptsAdvanced HNSCCConcurrent cisplatinN2 diseasePrimary endpointAdjuvant therapyMetastatic diseasePS 0Complete responseDisease recurrenceMedian ageNodal stage