2023
119O Long-term efficacy and patterns of response of lifileucel tumor-infiltrating lymphocyte (TIL) cell therapy in patients with advanced melanoma: A 4-year analysis of the C-144-01 study
Medina T, Chesney J, Whitman E, Kluger H, Thomas S, Sarnaik A, Kirkwood J, Larkin J, Weber J, Hamid O, Wermke M, Finckenstein F, Chou J, Gastman B, Sulur G, Wu X, Shi W, Domingo-Musibay E. 119O Long-term efficacy and patterns of response of lifileucel tumor-infiltrating lymphocyte (TIL) cell therapy in patients with advanced melanoma: A 4-year analysis of the C-144-01 study. Immuno-Oncology Technology 2023, 20: 100591. DOI: 10.1016/j.iotech.2023.100591.Peer-Reviewed Original Research776 Long-term efficacy and safety of lifileucel tumor-infiltrating lymphocyte (TIL) cell therapy in patients with advanced melanoma: a 4-year analysis of the C-144–01 study
Medina T, Chesney J, Whitman E, Kluger H, Thomas S, Sarnaik A, Kirkwood J, Larkin J, Weber J, Hamid O, Wermke M, Finckenstein F, Chou J, Gastman B, Sulur G, Wu X, Shi W, Domingo-Musibay E. 776 Long-term efficacy and safety of lifileucel tumor-infiltrating lymphocyte (TIL) cell therapy in patients with advanced melanoma: a 4-year analysis of the C-144–01 study. 2023, a873-a873. DOI: 10.1136/jitc-2023-sitc2023.0776.Peer-Reviewed Original Research1086MO Lifileucel tumor-infiltrating lymphocyte (TIL) cell therapy in patients (pts) with advanced mucosal melanoma after progression on immune checkpoint inhibitors (ICI): Results from the phase II C-144-01 study
Grigoleit G, Kluger H, Thomas S, Chesney J, Domingo-Musibay E, Sanmamed M, Medina T, Ziemer M, Whitman E, Finckenstein F, Chou J, Wu X, Sulur G, Shi W, Sarnaik A. 1086MO Lifileucel tumor-infiltrating lymphocyte (TIL) cell therapy in patients (pts) with advanced mucosal melanoma after progression on immune checkpoint inhibitors (ICI): Results from the phase II C-144-01 study. Annals Of Oncology 2023, 34: s654. DOI: 10.1016/j.annonc.2023.09.2220.Peer-Reviewed Original ResearchSociety for Immunotherapy of Cancer (SITC) checkpoint inhibitor resistance definitions: efforts to harmonize terminology and accelerate immuno-oncology drug development
Tawbi H, Sullivan R, Feltquate D, LaVallee T, Rizvi N, Sharon E, Sosman J, Kluger H. Society for Immunotherapy of Cancer (SITC) checkpoint inhibitor resistance definitions: efforts to harmonize terminology and accelerate immuno-oncology drug development. Journal For ImmunoTherapy Of Cancer 2023, 11: e007309. PMID: 37487665, PMCID: PMC10373737, DOI: 10.1136/jitc-2023-007309.Peer-Reviewed Original Research290 Response to Lifileucel Tumor-Infiltrating Lymphocyte (TIL) Cell Therapy after ICI Resistance Regardless of Definition: An Analysis of the C-144-01 Trial in Patients with Advanced Melanoma
Sarnaik A, Chesney J, Medina T, Hamid O, Thomas S, Wermke M, Gontcharova V, Damirchi B, Dean J, Mastellar E, Wu X, Shi W, Kluger H. 290 Response to Lifileucel Tumor-Infiltrating Lymphocyte (TIL) Cell Therapy after ICI Resistance Regardless of Definition: An Analysis of the C-144-01 Trial in Patients with Advanced Melanoma. Transplantation And Cellular Therapy 2023, 29: s223-s224. DOI: 10.1016/s2666-6367(23)00359-7.Peer-Reviewed Original Research
2022
Longitudinal single-cell analysis of a patient receiving adoptive cell therapy reveals potential mechanisms of treatment failure
Qu R, Kluger Y, Yang J, Zhao J, Hafler D, Krause D, Bersenev A, Bosenberg M, Hurwitz M, Lucca L, Kluger H. Longitudinal single-cell analysis of a patient receiving adoptive cell therapy reveals potential mechanisms of treatment failure. Molecular Cancer 2022, 21: 219. PMID: 36514045, PMCID: PMC9749221, DOI: 10.1186/s12943-022-01688-5.Peer-Reviewed Original ResearchConceptsAdoptive cell therapySingle-cell analysisDepth single-cell analysisSingle-cell RNAACT productsDisease progressionT-cell receptor sequencingCell therapyFamily genesFeatures of exhaustionMultiple tumor typesCell expansionGenesNew clonotypesTIL preparationsClonal cell expansionCytokine therapyTreatment failureSerial bloodClonesEffector functionsSerial samplesTumor typesCellular therapyTherapy35MO Number of IL-2 doses and clinical outcomes of tumor-infiltrating lymphocyte (TIL) cell therapy: Post hoc analysis of the C-144-01 trial of lifileucel in patients with advanced melanoma
Hassel J, Sarnaik A, Chesney J, Medina T, Hamid O, Thomas S, Wermke M, Domingo-Musibay E, Kirkwood J, Larkin J, Weber J, Fernandez A, Rodriguez J, Thomas I, Corrie P, Gontcharova V, Wu X, Shi W, Kluger H. 35MO Number of IL-2 doses and clinical outcomes of tumor-infiltrating lymphocyte (TIL) cell therapy: Post hoc analysis of the C-144-01 trial of lifileucel in patients with advanced melanoma. Immuno-Oncology Technology 2022, 16: 100140. DOI: 10.1016/j.iotech.2022.100140.Peer-Reviewed Original Research789 Lifileucel TIL cell monotherapy in patients with advanced melanoma after progression on immune checkpoint inhibitors (ICI) and targeted therapy: pooled analysis of consecutive cohorts (C-144–01 study)
Sarnaik A, Lewis K, Kluger H, Hamid O, Whitman E, Thomas S, Wermke M, Cusnir M, Domingo-Musibay E, Phan G, Kirkwood J, Hassel J, Orloff M, Larkin J, Weber J, Furness A, Khushalani N, Medina T, Finckenstein F, Jagasia M, Hari P, Sulur G, Shi W, Wu X, Chesney J. 789 Lifileucel TIL cell monotherapy in patients with advanced melanoma after progression on immune checkpoint inhibitors (ICI) and targeted therapy: pooled analysis of consecutive cohorts (C-144–01 study). 2022, a821-a822. DOI: 10.1136/jitc-2022-sitc2022.0789.Peer-Reviewed Original Research844P Efficacy and safety of lifileucel, an investigational autologous tumor-infiltrating lymphocyte (TIL) cell therapy, in patients with advanced melanoma previously treated with anti-LAG3 antibody
Larkin J, Dalle S, Sanmamed M, Wilson M, Hassel J, Kluger H, Orloff M, Weber J, Finckenstein F, Hari P, Jagasia M, Yin H, Shi W, Sulur G, Wu X, Gontcharova V, Lewis K. 844P Efficacy and safety of lifileucel, an investigational autologous tumor-infiltrating lymphocyte (TIL) cell therapy, in patients with advanced melanoma previously treated with anti-LAG3 antibody. Annals Of Oncology 2022, 33: s935-s936. DOI: 10.1016/j.annonc.2022.07.970.Peer-Reviewed Original ResearchMelanoma central nervous system metastases: An update to approaches, challenges, and opportunities
Karz A, Dimitrova M, Kleffman K, Alvarez‐Breckenridge C, Atkins MB, Boire A, Bosenberg M, Brastianos P, Cahill DP, Chen Q, Ferguson S, Forsyth P, Oliva I, Goldberg SB, Holmen SL, Knisely JPS, Merlino G, Nguyen DX, Pacold ME, Perez‐Guijarro E, Smalley KSM, Tawbi HA, Wen PY, Davies MA, Kluger HM, Mehnert JM, Hernando E. Melanoma central nervous system metastases: An update to approaches, challenges, and opportunities. Pigment Cell & Melanoma Research 2022, 35: 554-572. PMID: 35912544, PMCID: PMC10171356, DOI: 10.1111/pcmr.13059.Peer-Reviewed Original ResearchConceptsMelanoma brain metastasesMBM patientsBrain metastasesCheckpoint inhibitor trialsCommon brain malignancyMelanoma Research FoundationDedicated clinical trialsRole of astrocytesNovel treatment approachesImmunotherapy trialsInhibitor trialsBrain malignanciesClinical trialsPatient outcomesBrain microenvironmentTreatment approachesPatient advocatesPatientsTrialsTherapeutic purposesMetabolic adaptationMetastasisCurrent standardTherapyRecent reports
2020
801 PRIME™ IL-15 (RPTR-147): Preliminary clinical results and biomarker analysis from a first-in-human Phase 1 study of IL-15 loaded peripherally-derived autologous T cell therapy in solid tumor patients
Hamilton E, Nikiforow S, Bardwell P, McInnis C, Zhang J, Blumenschein G, Cristea M, Osman K, Shields A, Motta M, Bilic S, Schoenborn-Kellenberger O, Rakestraw J, Carey S, Geretti E, Sauer K, Harris T, Maniar T, Hewes B, Andresen T, Fitzgerald J, Kluger H. 801 PRIME™ IL-15 (RPTR-147): Preliminary clinical results and biomarker analysis from a first-in-human Phase 1 study of IL-15 loaded peripherally-derived autologous T cell therapy in solid tumor patients. Journal For ImmunoTherapy Of Cancer 2020, 8: a850-a850. DOI: 10.1136/jitc-2020-sitc2020.0801.Peer-Reviewed Original ResearchNeoadjuvant anti–programmed cell death 1 therapy for locally advanced basal cell carcinoma in treatment-naive patients: A case series
Ligtenberg KG, Hu JK, Damsky W, Olino K, Kluger H, Clune J, Cowper SE, Panse G, Leventhal J, Weiss SA. Neoadjuvant anti–programmed cell death 1 therapy for locally advanced basal cell carcinoma in treatment-naive patients: A case series. JAAD Case Reports 2020, 6: 628-633. PMID: 32613057, PMCID: PMC7317689, DOI: 10.1016/j.jdcr.2020.05.010.Peer-Reviewed Case Reports and Technical NotesP865 Safety & efficacy of lifileucel (LN-144) tumor infiltrating lymphocyte therapy in metastatic melanoma patients after progression on multiple therapies – independent review committee data update
Sarnaik A, Khushalani N, Chesney J, Kluger H, Curti B, Lewis K, Medina T, Thomas S, Pavlick A, Whitman E, Algarra S, Corrie P, Hamid O, Lutzky J, Olah J, Weber J, Larkin J, Shi W, DiTrapani K, Qin H, Mirgoli M, Wu R, Takamura T, Fardis M, Kirkwood J. P865 Safety & efficacy of lifileucel (LN-144) tumor infiltrating lymphocyte therapy in metastatic melanoma patients after progression on multiple therapies – independent review committee data update. Journal For ImmunoTherapy Of Cancer 2020, 8: a12. DOI: 10.1136/lba2019.18.Peer-Reviewed Original ResearchMelanoma Brain Metastases: Unique Biology and Implications for Systemic Therapy
Margolin K, Davies M, Kluger H, Tawbi H. Melanoma Brain Metastases: Unique Biology and Implications for Systemic Therapy. 2020, 1421-1454. DOI: 10.1007/978-3-030-05070-2_65.Peer-Reviewed Original ResearchMelanoma brain metastasesCentral nervous systemSystemic therapyClinical benefitMainstay of therapyUnique patient populationDuration of responseHigh response rateFuture drug developmentMelanoma metastaticBrain metastasesDevastating complicationDurable responsesImmune checkpointsImmune therapyPatient populationMetastatic melanomaEffective modalityStereotactic radiosurgeryNervous systemResponse rateTherapyMultidisciplinary approachDrug developmentMelanoma
2019
Frequent Use of Local Therapy Underscores Need for Multidisciplinary Care in the Management of Patients With Melanoma Brain Metastases Treated With PD-1 Inhibitors
Qian JM, Yu JB, Mahajan A, Goldberg SB, Kluger HM, Chiang VLS. Frequent Use of Local Therapy Underscores Need for Multidisciplinary Care in the Management of Patients With Melanoma Brain Metastases Treated With PD-1 Inhibitors. International Journal Of Radiation Oncology • Biology • Physics 2019, 105: 1113-1118. PMID: 31479702, DOI: 10.1016/j.ijrobp.2019.08.053.Peer-Reviewed Original ResearchConceptsBrain metastasesLocal therapyNeurologic safetyMelanoma patientsProspective phase 2 trialProgressive brain metastasesSerial brain imagingMelanoma brain metastasesPD-1 inhibitorsPhase 2 trialRapid disease progressionManagement of patientsNeurologic symptomsMultidisciplinary careTrial enrollmentCystic changesClinical trialsDisease progressionPatientsLesion sizeMetastasisMultidisciplinary teamTumor growthTherapyClinical decisionMelanoma Brain Metastases: Unique Biology and Implications for Systemic Therapy
Margolin K, Davies M, Kluger H, Tawbi H. Melanoma Brain Metastases: Unique Biology and Implications for Systemic Therapy. 2019, 1-34. DOI: 10.1007/978-3-319-46029-1_65-1.Peer-Reviewed Original ResearchMelanoma brain metastasesCentral nervous systemSystemic therapyClinical benefitMainstay of therapyUnique patient populationDuration of responseHigh response rateFuture drug developmentMelanoma metastaticBrain metastasesDevastating complicationDurable responsesImmune checkpointsImmune therapyPatient populationMetastatic melanomaEffective modalityStereotactic radiosurgeryNervous systemResponse rateTherapyMultidisciplinary approachDrug developmentMelanoma
2018
Final Results of a Phase I Prospective Trial Evaluating the Combination of Stereotactic Body Radiation Therapy (SBRT) with Concurrent Pembrolizumab in Patients with Metastatic Non-Small Cell Lung Cancer (NSCLC) or Melanoma
Campbell A, Herbst R, Gettinger S, Goldberg S, Kluger H, Chiang A, Lilenbaum R, Schalper K, Sowell R, Kaech S, Decker R. Final Results of a Phase I Prospective Trial Evaluating the Combination of Stereotactic Body Radiation Therapy (SBRT) with Concurrent Pembrolizumab in Patients with Metastatic Non-Small Cell Lung Cancer (NSCLC) or Melanoma. International Journal Of Radiation Oncology • Biology • Physics 2018, 102: s18-s19. DOI: 10.1016/j.ijrobp.2018.06.134.Peer-Reviewed Original ResearchDurable tumor regression and overall survival (OS) in patients with advanced Merkel cell carcinoma (aMCC) receiving pembrolizumab as first-line therapy.
Nghiem P, Bhatia S, Lipson E, Sharfman W, Kudchadkar R, Friedlander P, Brohl A, Daud A, Kluger H, Reddy S, Burgess M, Hanks B, Olencki T, Boulmay B, Lundgren L, Ramchurren N, Homet Moreno B, Sharon E, Cheever M, Topalian S. Durable tumor regression and overall survival (OS) in patients with advanced Merkel cell carcinoma (aMCC) receiving pembrolizumab as first-line therapy. Journal Of Clinical Oncology 2018, 36: 9506-9506. DOI: 10.1200/jco.2018.36.15_suppl.9506.Peer-Reviewed Original ResearchPerilesional edema and blood vessel characteristics in brain metastases and implications for treatment with immune therapy.
Tran T, Jilaveanu L, Mahajan A, Goldberg S, Nguyen D, Chiang V, Kluger H. Perilesional edema and blood vessel characteristics in brain metastases and implications for treatment with immune therapy. Journal Of Clinical Oncology 2018, 36: 9572-9572. DOI: 10.1200/jco.2018.36.15_suppl.9572.Peer-Reviewed Original ResearchEarly B cell changes predict autoimmunity following combination immune checkpoint blockade
Das R, Bar N, Ferreira M, Newman AM, Zhang L, Bailur JK, Bacchiocchi A, Kluger H, Wei W, Halaban R, Sznol M, Dhodapkar MV, Dhodapkar KM. Early B cell changes predict autoimmunity following combination immune checkpoint blockade. Journal Of Clinical Investigation 2018, 128: 715-720. PMID: 29309048, PMCID: PMC5785243, DOI: 10.1172/jci96798.Peer-Reviewed Original ResearchConceptsCombination checkpoint blockadeB cell changesB cellsCheckpoint blockadeCell changesCombination immune checkpoint blockadeB-cell receptor sequencingRisk of irAEsImmune checkpoint blockadeCell receptor sequencingB cell activationTreatment-induced changesCCB therapyAdverse eventsPD1 expressionPD1 receptorGrade 3PatientsCell activationEarly changesSingle-cell RNA sequencingTherapyPreemptive strategyCancer therapyIrAEs