2025
Artificial Intelligence Algorithm Predicts Response to Immune Checkpoint Inhibitors
Fa’ak F, Coudray N, Jour G, Ibrahim M, Illa-Bochaca I, Qiu S, Quiros A, Yuan K, Johnson D, Rimm D, Weber J, Tsirigos A, Osman I. Artificial Intelligence Algorithm Predicts Response to Immune Checkpoint Inhibitors. Clinical Cancer Research 2025, 31: 3526-3536. PMID: 40553453, PMCID: PMC12351278, DOI: 10.1158/1078-0432.ccr-24-3720.Peer-Reviewed Original ResearchResponse to ICIImmune checkpoint inhibitorsMetastatic melanoma cohortCheckpoint inhibitorsMelanoma cohortMelanoma treated with immune checkpoint inhibitorsBiomarkers of ICI responseImmune checkpoint inhibitor useImmune checkpoint inhibitor treatmentCohort of melanoma patientsLow tumor stroma ratioProgression-free survivalTumor-stroma ratioSignificant adverse eventsArea under the curvePatient overall survivalMetastatic settingUnresectable melanomaEpithelioid histologyICI responseMelanoma patientsMetastatic melanomaOverall survivalPatient survivalTumor featuresClinical factors influencing retreatment with anti-PD-(L)1 therapies after treatment in early-stage cancers: a modified Delphi consensus study
Pusztai L, Sondak V, Aguiar-Ibáñez R, Cappuzzo F, Chouaid C, Elder C, Hirasawa Y, Ishida M, Jones R, Lee S, Mizuno R, Nagata M, Okonji D, Parente P, Shah B, Sun A, Ferreira D, Spiteri C, Lauer A, Kaliasethi A, Kao C, Kothari S, McKendrick J. Clinical factors influencing retreatment with anti-PD-(L)1 therapies after treatment in early-stage cancers: a modified Delphi consensus study. Journal For ImmunoTherapy Of Cancer 2025, 13: e011184. PMID: 40425232, PMCID: PMC12107590, DOI: 10.1136/jitc-2024-011184.Peer-Reviewed Original ResearchConceptsAnti-PD-(L)1 treatmentAnti-PD-(L)1Anti-PD-(L)1 therapyEarly-stage cancerAnti-PD-(L)1 agentsRetreatment of patientsAnti-programmed deathTreating early-stage cancersAdjuvant settingMetastatic settingNeoadjuvant settingRetreatment patientsClinical expertsAdjuvant treatmentEarly-stage treatmentRetreatment decisionsClinical factorsRepeated TreatmentTherapyCancer typesCancerPatient responseClinical practicePatientsRelapseCharacterizing Chronic Cutaneous Immune-Related Adverse Events Following Immune Checkpoint Inhibitors
Fletcher K, Goodman R, Lawless A, Woodford R, Fa’ak F, Tipirneni A, Patrinely J, Yeoh H, Rapisuwon S, Haydon A, Osman I, Mehnert J, Long G, Sullivan R, Carlino M, Menzies A, Dewan A, Johnson D. Characterizing Chronic Cutaneous Immune-Related Adverse Events Following Immune Checkpoint Inhibitors. JAMA Dermatology 2025, 161: 555-557. PMID: 40072456, PMCID: PMC11904794, DOI: 10.1001/jamadermatol.2025.0025.Peer-Reviewed Original Research
2024
A phase 1 dose expansion study of a first-in-class KAT6 inhibitor (PF-07248144) in patients with advanced or metastatic ER+ HER2− breast cancer.
Mukohara T, Park Y, Sommerhalder D, Yonemori K, Kim S, Kim J, Iwata H, Yamashita T, Layman R, Kim G, Im S, Lindeman G, Rugo H, Liyanage M, Homji Mishra N, Maity A, Bogg O, Liu L, Li M, LoRusso P. A phase 1 dose expansion study of a first-in-class KAT6 inhibitor (PF-07248144) in patients with advanced or metastatic ER+ HER2− breast cancer. Journal Of Clinical Oncology 2024, 42: 3006-3006. DOI: 10.1200/jco.2024.42.16_suppl.3006.Peer-Reviewed Original ResearchHER2- metastatic breast cancerTreatment-related adverse eventsMetastatic breast cancerCirculating tumor DNABreast cancerGene mutationsFrequent treatment-related adverse eventsMedian duration of follow-upAntitumor activityDuration of follow-upClinical benefit rateProgression-free survivalHER2 breast cancerMutant allele frequencyExpansion doseFulvestrant combinationMedian DORESR1 mutationsMetastatic settingDose modificationEndocrine therapySystemic therapyMedian durationTumor DNACDK4/6 inhibitorsPooled analysis by best confirmed response to trastuzumab deruxtecan (T-DXd) in patients (pts) with HER2+ metastatic breast cancer (mBC) from DESTINY-Breast-01, -02, and -03.
Saura C, Cortés J, Modi S, Kim S, Hamilton E, Hurvitz S, Krop I, Curigliano G, Iwata H, Im S, Herbolsheimer P, Karnoub M, Gambhire D, Egorov A, Andre F. Pooled analysis by best confirmed response to trastuzumab deruxtecan (T-DXd) in patients (pts) with HER2+ metastatic breast cancer (mBC) from DESTINY-Breast-01, -02, and -03. Journal Of Clinical Oncology 2024, 42: 1023-1023. DOI: 10.1200/jco.2024.42.16_suppl.1023.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsHER2+ metastatic breast cancerProgression-free survivalMetastatic breast cancerComplete responsePartial responseT-DXdOverall survivalPooled analysisInterstitial lung disease (ILD)/pneumonitisStable disease (SD)/progressive diseaseProlonged progression-free survivalDuration of responseIndependent central reviewNumerically lower ratesLonger treatment durationMetastatic settingRECIST v1.1Trastuzumab deruxtecanOS outcomesCentral reviewAdverse eventsBreast cancerTreatment durationDrug-relatedWhat Proportion of BRCA–Associated Breast Cancer Is Human Epidermal Growth Factor 2–Low and Eligible for Additional Targeted Therapy?
Forester E, Belsare A, Kim D, Whitaker K, Obeid E, Goldstein L, Bleicher R, Daly M, Williams A. What Proportion of BRCA–Associated Breast Cancer Is Human Epidermal Growth Factor 2–Low and Eligible for Additional Targeted Therapy? Journal Of Surgical Research 2024, 299: 217-223. PMID: 38776577, DOI: 10.1016/j.jss.2024.04.032.Peer-Reviewed Original ResearchTriple negative breast cancerHuman epidermal growth factor 2HER2-lowBreast cancerTargeted therapyMetachronous contralateral breast cancerPathogenic variantsHuman epidermal growth factor 2 statusBRCA-associated breast cancerRetrospective chart review of patientsChart review of patientsContralateral breast cancerBRCA gene statusInvasive breast cancerTargeted therapy optionsReview of patientsHR+/HER2- breast cancerRetrospective chart reviewNegative breast cancerFluorescence in situ hybridizationHER2 dataMetastatic settingTrastuzumab deruxtecanHER2-positiveGrowth factor 2Infigratinib versus placebo in patients with resected urothelial cancer (UC) bearing FGFR3 mutation or fusion: Primary DFS analysis from the phase 3, randomized PROOF302 study.
Pal S, Grivas P, Gupta S, Valderrama B, Rodriguez-Vida A, Roghmann F, Sevillano E, Matin S, Loriot Y, Sridhar S, Sonpavde G, Fleming M, Lerner S, Bellmunt J, Master V, Tripathi A, Davis K, Van Veenhuyzen D, Weng R, Daneshmand S. Infigratinib versus placebo in patients with resected urothelial cancer (UC) bearing FGFR3 mutation or fusion: Primary DFS analysis from the phase 3, randomized PROOF302 study. Journal Of Clinical Oncology 2024, 42: 629-629. DOI: 10.1200/jco.2024.42.4_suppl.629.Peer-Reviewed Original ResearchDisease-free survivalMetastasis-free survivalOverall survivalUrothelial cancerFibroblast growth factor 3FGFR3 alterationsAdjuvant therapyAdverse eventsInvestigator-assessed disease-free survivalMulticenter phase III clinical trialAssessed disease-free survivalPhase III clinical trialsLower tract UCUpper tract UCDays of randomizationFatal adverse eventsIII clinical trialsPrecision oncology trialsDFS analysisMetastatic settingOral infigratinibRadical surgeryDisease recurrenceFrequent gradeInvasive UCSacituzumab Govitecan in Combination With Pembrolizumab for Patients With Metastatic Urothelial Cancer That Progressed After Platinum-Based Chemotherapy: TROPHY-U-01 Cohort 3
Grivas P, Pouessel D, Park C, Barthelemy P, Bupathi M, Petrylak D, Agarwal N, Gupta S, Fléchon A, Ramamurthy C, Davis N, Recio-Boiles A, Sternberg C, Bhatia A, Pichardo C, Sierecki M, Tonelli J, Zhou H, Tagawa S, Loriot Y. Sacituzumab Govitecan in Combination With Pembrolizumab for Patients With Metastatic Urothelial Cancer That Progressed After Platinum-Based Chemotherapy: TROPHY-U-01 Cohort 3. Journal Of Clinical Oncology 2024, 42: 1415-1425. PMID: 38261969, PMCID: PMC11095901, DOI: 10.1200/jco.22.02835.Peer-Reviewed Original ResearchMetastatic urothelial cancerPlatinum-based chemotherapyClinical benefit rateProgression-free survivalDuration of responseSacituzumab govitecanCheckpoint inhibitorsCohort 3Central reviewUrothelial cancerFirst-line platinum-based chemotherapyOpen-label phase II studyDay 1Median duration of responseMedian progression-free survivalTreatment-related adverse eventsMedian overall survivalMedian Follow-UpPhase II studySecondary end pointsAntibody-drug conjugatesMetastatic settingOverall survivalStandard therapyII studyNF-κB associated markers of prognosis in early and metastatic triple negative breast cancer
De La Cruz P, McAdams J, Morales Aquino M, Fernandez A, Elliott A, Lustberg M, Schorl C, Ribeiro J, James N. NF-κB associated markers of prognosis in early and metastatic triple negative breast cancer. Breast Cancer Research 2024, 26: 175. PMID: 39623404, PMCID: PMC11613493, DOI: 10.1186/s13058-024-01925-3.Peer-Reviewed Original ResearchConceptsNegative breast cancerBreast cancerAggressive subtypePrognostic markerBeta expressionMouse modelPD-1-based immunotherapyMetastatic triple negative breast cancerAggressive subtype of breast cancerBackgroundTriple negative breast cancerAssociated with tumor regressionSubtypes of breast cancerTriple negative breast cancerSyngeneic mouse modelSerum cytokine profilesMarker of prognosisPatient clinical outcomesTargeted treatment approachesMetastatic settingPD-1Tumor regressionTNBC cohortFrontline chemotherapySurvival outcomesCytokine profile
2023
Radiation Synergizes with IL2/IL15 Stimulation to Enhance Innate Immune Activation and Antitumor Immunity.
Li X, Huntoon K, Wang Y, Lee D, Dong S, Antony A, Walkey C, Kim B, Jiang W. Radiation Synergizes with IL2/IL15 Stimulation to Enhance Innate Immune Activation and Antitumor Immunity. Molecular Cancer Therapeutics 2023, 23: 330-342. PMID: 37956421, DOI: 10.1158/1535-7163.mct-23-0236.Peer-Reviewed Original ResearchTumor growth inhibitionDendritic cellsAnti-PD-1 checkpoint inhibitorsAntigen-specific T cellsIL-2/ILGreater tumor infiltrationImmune stimulatory mechanismsMurine breast cancer modelAntitumor immune responseCombination of radiotherapyInnate immune activationType I interferon productionImmune-modulatory propertiesIL-15 receptorBreast cancer modelI interferon productionSuperior tumor growth inhibitionGrowth inhibitionInterferon genes (STING) pathwaySystemic immunotherapyWestern blot analysisCheckpoint inhibitorsMetastatic settingAntitumor immunitySurvival benefitPhase II study of trifluridine/tipiracil (FTD/TPI) in HER2-negative metastatic breast cancers with or without prior exposure to fluoropyrimidines.
Lim J, Ow S, Wong A, Lee M, Chan G, Low J, Sundar R, Choo J, Tai B, Lee S. Phase II study of trifluridine/tipiracil (FTD/TPI) in HER2-negative metastatic breast cancers with or without prior exposure to fluoropyrimidines. Journal Of Clinical Oncology 2023, 41: 1099-1099. DOI: 10.1200/jco.2023.41.16_suppl.1099.Peer-Reviewed Original ResearchObjective response rateMetastatic breast cancerProgression-free survivalPhase II studyLead-in phaseCohort ADose modificationBreast cancerDetermination of progression-free survivalSingle arm phase II studyHER2-negative metastatic breast cancerConsistent with known toxicitiesMedian progression-free survivalTreatment-related adverse eventsResponse rateDose-confirmation phaseEvents of neutropeniaTreated with FTD/TPIClinical benefit rateDose-limiting toxicityOral drug combinationsTreatment of patientsAnti-tumor activityThymidine phosphorylase inhibitorMetastatic settingPaclitaxel With or Without Cixutumumab as Second-Line Treatment of Metastatic Esophageal or Gastroesophageal Junction Cancer: A Randomized Phase II ECOG-ACRIN Trial
Stockton S, Catalano P, Cohen S, Burtness B, Mitchell E, Dotan E, Lubner S, Kumar P, Mulcahy M, Fisher G, Crandall T, Benson A. Paclitaxel With or Without Cixutumumab as Second-Line Treatment of Metastatic Esophageal or Gastroesophageal Junction Cancer: A Randomized Phase II ECOG-ACRIN Trial. The Oncologist 2023, 28: 827-e822. PMID: 37104870, PMCID: PMC10485278, DOI: 10.1093/oncolo/oyad096.Peer-Reviewed Original ResearchConceptsProgression-free survivalSecond-line therapyGastroesophageal junction cancerArm AMetastatic esophagealJunction cancerArm BMedian progression-free survivalRandomized phase II trialMedian overall survivalObjective response rateSecond-line treatmentAdvanced esophageal cancerInsulin-like growth factor 1 receptorPhase II trialStandard of careGrowth factor 1 receptorFactor 1 receptorStable diseaseII trialMetastatic settingPrimary endpointOverall survivalPreclinical evidenceClinical outcomesSociety for Immunotherapy of Cancer (SITC) consensus definitions for resistance to combinations of immune checkpoint inhibitors
Kluger H, Barrett J, Gainor J, Hamid O, Hurwitz M, LaVallee T, Moss R, Zappasodi R, Sullivan R, Tawbi H, Sharon E. Society for Immunotherapy of Cancer (SITC) consensus definitions for resistance to combinations of immune checkpoint inhibitors. Journal For ImmunoTherapy Of Cancer 2023, 11: e005921. PMID: 36918224, PMCID: PMC10016305, DOI: 10.1136/jitc-2022-005921.Peer-Reviewed Original ResearchConceptsImmune checkpoint inhibitorsCheckpoint inhibitorsAnti-PD-1 immune checkpoint inhibitorTrial designConsensus definitionConsensus clinical definitionExtended disease controlNew combination regimensImmunotherapy of cancerStandard of careLong-term survivalClinical trial designICI combinationsInitial immunotherapyMetastatic settingTreatment discontinuationDurable responsesTreatment landscapeCombination regimensMechanisms of resistancePerioperative settingPrimary resistanceClinical definitionDefinition of resistanceImmunotherapyTreating Head and Neck Cancer in the Age of Immunotherapy: A 2023 Update
Bhatia A, Burtness B. Treating Head and Neck Cancer in the Age of Immunotherapy: A 2023 Update. Drugs 2023, 83: 217-248. PMID: 36645621, DOI: 10.1007/s40265-023-01835-2.Commentaries, Editorials and LettersConceptsNeck cancerRecurrent/metastatic settingImmune checkpoint inhibitor nivolumabNeck squamous cell carcinomaAge of immunotherapyLate stage HNSCCImmune checkpoint inhibitionPlatinum-containing chemotherapyFirst-line treatmentGrowth factor receptor overexpressionCheckpoint inhibitor nivolumabSquamous cell carcinomaEpidermal growth factor receptor (EGFR) overexpressionPathogenesis of HNSCCTreatment of patientsTreatment of HNSCCManagement of headMonoclonal antibody cetuximabCurative intentPalliative chemotherapyAdvanced diseaseInhibitor nivolumabLocoregional failureMetastatic settingMultimodality therapy
2022
A randomized, phase II trial of oral azacitidine (CC-486) in patients with resected pancreatic adenocarcinoma at high risk for recurrence
Heumann T, Baretti M, Sugar E, Durham J, Linden S, Lopez-Vidal T, Leatherman J, Cope L, Sharma A, Weekes C, O’Dwyer P, Reiss K, Monga D, Ahuja N, Azad N. A randomized, phase II trial of oral azacitidine (CC-486) in patients with resected pancreatic adenocarcinoma at high risk for recurrence. Clinical Epigenetics 2022, 14: 166. PMID: 36463226, PMCID: PMC9719150, DOI: 10.1186/s13148-022-01367-8.Peer-Reviewed Original ResearchConceptsResectable pancreatic ductal adenocarcinomaCC-486OBS patientsMetastatic settingAdjuvant therapyTreatment-related grade 3Randomized phase II studyMedian age 66Next-line therapyResultsForty-nine patientsMedian treatment durationPhase II studyEvidence of diseaseHigh-risk featuresPhase II trialProgression-free survivalStandard adjuvant therapyPancreatic ductal adenocarcinomaCancer recursEvaluable patientsMedian OSMedian PFSOral azacitidineR1 resectionSubsequent chemotherapyA Phase 1 First-in-Human Study of FS118, a Tetravalent Bispecific Antibody Targeting LAG-3 and PD-L1 in Patients with Advanced Cancer and PD-L1 Resistance.
Yap T, LoRusso P, Wong D, Hu-Lieskovan S, Papadopoulos K, Holz J, Grabowska U, Gradinaru C, Leung K, Marshall S, Reader C, Russell R, Sainson R, Seal C, Shepherd C, Germaschewski F, Gliddon D, Stern O, Young L, Brewis N, Kayitalire L, Morrow M. A Phase 1 First-in-Human Study of FS118, a Tetravalent Bispecific Antibody Targeting LAG-3 and PD-L1 in Patients with Advanced Cancer and PD-L1 Resistance. Clinical Cancer Research 2022, 29: 888-898. PMID: 36342102, DOI: 10.1158/1078-0432.ccr-22-1449.Peer-Reviewed Original ResearchConceptsDisease control rateLAG-3PD-L1Advanced cancerOverall disease control rateDisease controlPeripheral effector cellsPhase 2 doseSerious adverse eventsPhase 1 studySoluble LAG-3Tetravalent bispecific antibodyPrior regimensStable diseaseDose expansionMetastatic settingAdverse eventsPartial responseEffector cellsClinical benefitControl rateSustained elevationTitration designPharmacodynamic activityHuman studiesAbstract 645: Heterogeneity of immunotherapy biomarkers in the TRACERx non-small cell lung cancer multi-region lung cancer cohort study
Hiley C, Litchfield K, Pich O, Moore D, Naceur-Lombardelli C, Veeriah S, Bakir M, Summan S, Grigoriadis K, Ruiz C, Puttick C, Enfield K, Ward S, Frankell A, Biswas D, Rosenthal R, Birkbak N, Jamal-Hanjani M, McGranahan N, Swanton C, Consortium T. Abstract 645: Heterogeneity of immunotherapy biomarkers in the TRACERx non-small cell lung cancer multi-region lung cancer cohort study. Cancer Research 2022, 82: 645-645. DOI: 10.1158/1538-7445.am2022-645.Peer-Reviewed Original ResearchNon-small cell lung cancerTumor mutational burdenIntra-tumor heterogeneityIntratumoral heterogeneityCancer Cohort StudyImmunotherapy biomarkersTumor regionAmerican Association for Cancer Research annual meetingsPredictors of response to immunotherapyCohort studyPrediction of immunotherapy responseTumor purityNeo-adjuvant settingResponse to immunotherapyFirst-line therapyImpact of intratumoral heterogeneityCell lung cancerMisclassification of patientsWhole-exome sequencingHeterogeneity of expressionMetastatic settingPDL1 immunohistochemistryPrimary tumorImmunotherapy responseMutational burdenSingle agent PD-1 blockade as curative-intent treatment in mismatch repair deficient locally advanced rectal cancer.
Cercek A, Lumish M, Sinopoli J, Weiss J, Shia J, Stadler Z, Yaeger R, Smith J, Saltz L, El Dika I, Crane C, Romesser P, Iyer K, Paty P, Garcia-Aguilar J, Gonen M, Gollub M, Weiser M, Schalper K, Diaz L. Single agent PD-1 blockade as curative-intent treatment in mismatch repair deficient locally advanced rectal cancer. Journal Of Clinical Oncology 2022, 40: lba5-lba5. DOI: 10.1200/jco.2022.40.17_suppl.lba5.Peer-Reviewed Original ResearchPD-1 blockadeAdvanced rectal cancerSingle-agent PD-1 blockadeClinical complete responseRectal cancerCo-primary endpointsComplete responseAnti-PD-1 monoclonal antibodyProspective phase II studyPD-1 monoclonal antibodyMismatch repair-deficient colorectal cancersCurative-intent treatmentPhase II studySerious adverse eventsCase of progressionEvidence of tumorDigital rectal examDeficient colorectal cancerMetastatic settingNeoadjuvant chemotherapyAdverse eventsCheckpoint blockadeII studySurgical resectionRectal adenocarcinomaClinical predictors of longer survival in patients with BRAFV600-mutated metastatic melanoma receiving immunotherapy prior to BRAF/MEK inhibition in the metastatic setting.
Kahn A, Perry C, Etts K, Kluger H, Sznol M. Clinical predictors of longer survival in patients with BRAFV600-mutated metastatic melanoma receiving immunotherapy prior to BRAF/MEK inhibition in the metastatic setting. Journal Of Clinical Oncology 2022, 40: 9555-9555. DOI: 10.1200/jco.2022.40.16_suppl.9555.Peer-Reviewed Original ResearchBRAF/MEKiFirst-line immunotherapyBRAF/MEK inhibitionBRAF V600Metastatic melanomaLonger survivalAdverse eventsMedian durationMost patientsBone metastasesClinical predictorsDisease progressionMEK inhibitionAdvanced BRAF V600ECOG PS 0Median ECOG PSFirst-line settingKaplan-Meier methodMost common sitePredictors of survivalECOG PSMedian LDHData cutoffMetastatic settingMedian survivalDual CDKN2A/MTAP loss compared to CDKN2A loss alone and response to immune-checkpoint inhibitors (ICI) in advanced solid tumors.
Adib E, Nassar A, El Zarif T, Kale N, Rakaee M, Mouhieddine T, Abou Alaiwi S, Freeman D, Labban M, Akl E, Haddad R, Hodi F, Sonpavde G, Giannakis M, Braun D, Gusev A, Choueiri T, Overstreet E, Stone E, Kwiatkowski D. Dual CDKN2A/MTAP loss compared to CDKN2A loss alone and response to immune-checkpoint inhibitors (ICI) in advanced solid tumors. Journal Of Clinical Oncology 2022, 40: 2622-2622. DOI: 10.1200/jco.2022.40.16_suppl.2622.Peer-Reviewed Original ResearchImmune checkpoint inhibitorsTumor-infiltrating lymphocytesLow TIL densityTreatment failureOverall survivalHazard ratioTIL densityGenomic alterationsCell carcinomaNon-small cell lung cancerDana-Farber Cancer InstituteCancer typesNeck squamous cell carcinomaAdvanced solid tumorsConcurrent systemic therapyCell lung cancerSquamous cell carcinomaTumor mutational burdenRenal cell carcinomaMelanoma tissue samplesMTAP lossHomozygous deletionECOG PSEsophagogastric carcinomaMetastatic setting
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