2023
A Phase II Trial of the CD40 Agonist Sotigalimab (APX005M) in Combination with Nivolumab in Subjects with Metastatic Melanoma with Disease Progression on Anti-PD-1
Weiss S, Sznol M, Shaheen M, Berciano-Guerrero M, Couselo E, Rodríguez-Abreu D, Boni V, Schuchter L, Gonzalez-Cao M, Arance A, Wei W, Ganti A, Hauke R, Berrocal A, Iannotti N, Hsu F, Kluger H. A Phase II Trial of the CD40 Agonist Sotigalimab (APX005M) in Combination with Nivolumab in Subjects with Metastatic Melanoma with Disease Progression on Anti-PD-1. Clinical Cancer Research 2023, 30: 74-81. PMID: 37535056, PMCID: PMC10767304, DOI: 10.1158/1078-0432.ccr-23-0475.Peer-Reviewed Original ResearchConceptsObjective response ratePhase II trialAdverse eventsPartial responseDisease progressionII trialGrade 3 adverse eventsAnti PD-1CD40 agonist antibodyElevated liver functionTreatment-related SAEsCommon adverse eventsActivation of CD40Subset of patientsFavorable safety profileAntigen presenting cellsStable diseaseMedian durationAdvanced melanomaAdditional patientsLiver functionSafety profileMetastatic melanomaPreclinical dataPresenting cells
2019
Immune Checkpoint Inhibitor Therapy in Patients With Preexisting Inflammatory Bowel Disease
Abu-Sbeih H, Faleck DM, Ricciuti B, Mendelsohn RB, Naqash AR, Cohen JV, Sellers MC, Balaji A, Ben-Betzalel G, Hajir I, Zhang J, Awad MM, Leonardi GC, Johnson DB, Pinato DJ, Owen DH, Weiss SA, Lamberti G, Lythgoe MP, Manuzzi L, Arnold C, Qiao W, Naidoo J, Markel G, Powell N, Yeung SJ, Sharon E, Dougan M, Wang Y. Immune Checkpoint Inhibitor Therapy in Patients With Preexisting Inflammatory Bowel Disease. Journal Of Clinical Oncology 2019, 38: 576-583. PMID: 31800340, PMCID: PMC7030892, DOI: 10.1200/jco.19.01674.Peer-Reviewed Original ResearchConceptsGI adverse eventsInflammatory bowel diseaseImmune checkpoint inhibitor therapyCheckpoint inhibitor therapyImmune checkpoint inhibitorsAdverse eventsCheckpoint inhibitorsBowel diseaseInhibitor therapyAnti-cytotoxic T-lymphocyte antigen-4 therapyTreatment of IBDCytotoxic T-lymphocyte antigen-4T-lymphocyte antigen-4Cell death 1Multivariate logistic regressionImmunotherapy initiationColonic perforationGI eventsDeath-1Ulcerative colitisCrohn's diseaseMedian timeMultivariable analysisRetrospective studySimilar patientsSeronegative autoimmune autonomic ganglionopathy from dual immune checkpoint inhibition in a patient with metastatic melanoma
Gao CA, Weber UM, Peixoto AJ, Weiss SA. Seronegative autoimmune autonomic ganglionopathy from dual immune checkpoint inhibition in a patient with metastatic melanoma. Journal For ImmunoTherapy Of Cancer 2019, 7: 262. PMID: 31623673, PMCID: PMC6796437, DOI: 10.1186/s40425-019-0748-0.Peer-Reviewed Original ResearchConceptsAutoimmune autonomic ganglionopathyImmune checkpoint inhibitor therapyMetastatic melanomaCheckpoint inhibitorsDual immune checkpoint inhibitionSympathetic nervous system responsesBackgroundImmune checkpoint inhibitorsCardiovascular autonomic testingCheckpoint inhibitor therapyImmune checkpoint inhibitionNervous system responsesEndocrine workupHypotension refractoryAutonomic testingImmunomodulatory therapyAdverse eventsCase presentationAFluid resuscitationInhibitor therapyCheckpoint inhibitionClinical outcomesDisease progressionNew symptomsEndocrine toxicityNivolumab
2018
Long-Term Survival of Patients With Melanoma With Active Brain Metastases Treated With Pembrolizumab on a Phase II Trial
Kluger HM, Chiang V, Mahajan A, Zito CR, Sznol M, Tran T, Weiss SA, Cohen JV, Yu J, Hegde U, Perrotti E, Anderson G, Ralabate A, Kluger Y, Wei W, Goldberg SB, Jilaveanu LB. Long-Term Survival of Patients With Melanoma With Active Brain Metastases Treated With Pembrolizumab on a Phase II Trial. Journal Of Clinical Oncology 2018, 37: 52-60. PMID: 30407895, PMCID: PMC6354772, DOI: 10.1200/jco.18.00204.Peer-Reviewed Original ResearchConceptsBrain metastasis responseBrain metastasesMetastasis responseAdverse eventsAnti-programmed cell death-1 (PD-1) agentsDeath ligand 1 (PD-L1) expressionModified Response Evaluation CriteriaPhase II clinical trialActive brain metastasesAsymptomatic brain metastasesCD8 cell densityNeurologic adverse eventsPembrolizumab-treated patientsUse of pembrolizumabMelanoma brain metastasesPrimary end pointLigand 1 expressionPhase II trialResponse Evaluation CriteriaT-cell infiltratesUntreated brain metastasesDeath ligand 1Two-year survivalOverall survival timeResult of progressionCollateral Damage: Insulin-Dependent Diabetes Induced With Checkpoint Inhibitors
Stamatouli AM, Quandt Z, Perdigoto AL, Clark PL, Kluger H, Weiss SA, Gettinger S, Sznol M, Young A, Rushakoff R, Lee J, Bluestone JA, Anderson M, Herold KC. Collateral Damage: Insulin-Dependent Diabetes Induced With Checkpoint Inhibitors. Diabetes 2018, 67: dbi180002. PMID: 29937434, PMCID: PMC6054443, DOI: 10.2337/dbi18-0002.Peer-Reviewed Original ResearchMeSH KeywordsAnimalsAntineoplastic Agents, ImmunologicalAutoimmune DiseasesB7-H1 AntigenDiabetes Mellitus, Type 1Genetic Predisposition to DiseaseGenotypeHLA-DR4 AntigenHumansHypoglycemic AgentsInsulinInsulin SecretionIsoantibodiesKetosisModels, ImmunologicalNeoplasmsPancreasPancreatitisProgrammed Cell Death 1 ReceptorConceptsInsulin-dependent diabetesCheckpoint inhibitorsAdverse eventsHLA-DR4Classic type 1 diabetesPD-L1 checkpoint inhibitorsEvidence of pancreatitisImmune adverse eventsSolid organ cancersType 1 diabetesPeridiagnosis periodPositive autoantibodiesL1 antibodyInsulin-DependentHigh riskPatientsDiabetesCancerInhibitorsKetoacidosisAutoimmuneAutoantibodiesPancreatitisComplicationsSyndrome
2016
Chapter 20 Management of Melanoma Therapy-Associated Toxicities
Weiss S, Kavecansky J, Pavlick A. Chapter 20 Management of Melanoma Therapy-Associated Toxicities. 2016, 299-319. DOI: 10.1016/b978-0-12-803508-5.00020-2.Peer-Reviewed Original ResearchSkin cancer-related deathsAntitumor immune responseUnique adverse eventsCancer-related deathPatient survival outcomesNew therapeutic strategiesQuality of lifeMelanoma driver mutationsChapter 20 ManagementAdverse eventsAdvanced melanomaSurvival outcomesImmune responseTherapeutic strategiesInitial approvalAggressive natureSkin cancerNew casesPatient safetyDriver mutationsMelanomaSignificant delayTherapyCliniciansVast majority
2015
Dabrafenib for the treatment of melanoma
Weiss S, Pavlick A. Dabrafenib for the treatment of melanoma. Expert Opinion On Orphan Drugs 2015, 3: 1075-1084. DOI: 10.1517/21678707.2015.1067136.Peer-Reviewed Original ResearchAdvanced melanomaBrain metastasesBRAF V600EEffective salvage therapyMilestone clinical trialsPractice-changing approachAdvanced melanoma patientsHigh tumor burdenMelanoma brain metastasesFirst-line therapyMajority of patientsMEK inhibitor trametinibBRAF inhibitor therapyTreatment of melanomaV600K mutationsMutant BRAF kinaseMechanism of actionSalvage therapyAdverse eventsInhibitor therapyMelanoma patientsTumor burdenPoor prognosisCancer symptomsIL-2