2021
Clinical Activity and Safety of Cediranib and Olaparib Combination in Patients with Metastatic Pancreatic Ductal Adenocarcinoma without BRCA Mutation
Kim J, Cardin DB, Vaishampayan UN, Kato S, Grossman SR, Glazer P, Shyr Y, Ivy SP, LoRusso P. Clinical Activity and Safety of Cediranib and Olaparib Combination in Patients with Metastatic Pancreatic Ductal Adenocarcinoma without BRCA Mutation. The Oncologist 2021, 26: e1104-e1109. PMID: 33742489, PMCID: PMC8265343, DOI: 10.1002/onco.13758.Peer-Reviewed Original ResearchConceptsMetastatic pancreatic adenocarcinomaHomologous recombination DNA repair deficiencyMetastatic pancreatic ductal adenocarcinomaPancreatic ductal adenocarcinomaOlaparib combinationStable diseaseBRCA mutationsAdverse eventsDuctal adenocarcinomaCommon treatment-related adverse eventsVascular endothelial growth factor receptor inhibitorEndothelial growth factor receptor inhibitorTreatment-related adverse eventsGrowth factor receptor inhibitorsPrior systemic chemotherapyMedian overall survivalObjective response rateGermline BRCA mutationsBest overall responseExpression of BRCA1/2Restaging scanCancer cell linesPrimary endpointStudy drugSystemic chemotherapySapanisertib, a dual mTORC1/2 inhibitor, for TSC1- or TSC2- mutated metastatic urothelial carcinoma (mUC).
Kim J, Milowsky M, Hahn N, Kwiatkowski D, Morgans A, Davis N, Appleman L, Gupta S, Lara P, Hoffman-Censits J, Quinn D, Shyr Y, LoRusso P, Sklar J, Petrylak D. Sapanisertib, a dual mTORC1/2 inhibitor, for TSC1- or TSC2- mutated metastatic urothelial carcinoma (mUC). Journal Of Clinical Oncology 2021, 39: 431-431. DOI: 10.1200/jco.2021.39.6_suppl.431.Peer-Reviewed Original ResearchMetastatic urothelial carcinomaStable diseaseAdverse eventsObjective responseWithdrew consentTSC2 mutationsUrothelial carcinomaTSC1 mutationsTumor samplesCommon adverse eventsMedian overall survivalTreatment-related deathsPhase II studyCentral labOverall response rateDual mTORC1/2 inhibitorUnknown mutational statusCentral confirmationEligible patientsEvaluable patientsMUC patientsRestaging scanII studyPrimary endpointBaseline characteristicsSafety and Clinical Activity of Atezolizumab in Patients with Metastatic Castration-Resistant Prostate Cancer: A Phase I StudyAtezolizumab in Castration-Resistant Prostate Cancer
Petrylak DP, Loriot Y, Shaffer DR, Braiteh F, Powderly J, Harshman LC, Conkling P, Delord JP, Gordon M, Kim JW, Sarkar I, Yuen K, Kadel EE, Mariathasan S, O'Hear C, Narayanan S, Fassò M, Carroll S, Powles T. Safety and Clinical Activity of Atezolizumab in Patients with Metastatic Castration-Resistant Prostate Cancer: A Phase I StudyAtezolizumab in Castration-Resistant Prostate Cancer. Clinical Cancer Research 2021, 27: 3360-3369. PMID: 33568344, DOI: 10.1158/1078-0432.ccr-20-1981.Peer-Reviewed Original ResearchConceptsMetastatic castration-resistant prostate cancerCastration-resistant prostate cancerPartial responseProstate cancerAtezolizumab monotherapyOverall survivalPrior linesImmune-related response criteriaTreatment-related adverse eventsDose-expansion studyPSA response rateMedian overall survivalBiomarker analysisEvaluable patientsRECIST 1.1Adverse eventsOS ratesClinical benefitSafety profileDisease progressionAtezolizumabClinical activityRadiographic assessmentImmune responseLimited efficacy
2018
Atezolizumab (MPDL3280A) Monotherapy for Patients With Metastatic Urothelial Cancer: Long-term Outcomes From a Phase 1 Study
Petrylak DP, Powles T, Bellmunt J, Braiteh F, Loriot Y, Morales-Barrera R, Burris HA, Kim JW, Ding B, Kaiser C, Fassò M, O’Hear C, Vogelzang NJ. Atezolizumab (MPDL3280A) Monotherapy for Patients With Metastatic Urothelial Cancer: Long-term Outcomes From a Phase 1 Study. JAMA Oncology 2018, 4: 537-544. PMID: 29423515, PMCID: PMC5885219, DOI: 10.1001/jamaoncol.2017.5440.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedCarcinoma, Transitional CellCohort StudiesDose-Response Relationship, DrugDrug-Related Side Effects and Adverse ReactionsFemaleFollow-Up StudiesHumansMaleMiddle AgedNeoplasm MetastasisSurvival AnalysisTime FactorsUrinary Bladder NeoplasmsUrotheliumConceptsDeath ligand 1 (PD-L1) expressionMedian overall survivalMetastatic urothelial carcinomaLigand 1 expressionProgression-free survivalPhase 1 studyOverall survivalAdverse eventsClinical benefitUrothelial carcinomaImmune cellsEastern Cooperative Oncology Group performance status 0Long-term clinical profilesMedian progression-free survivalSerious related adverse eventsSolid Tumors version 1.1Treatment-related adverse eventsLong-term clinical outcomesTumor-infiltrating immune cellsPerformance status 0Treatment-related deathsUnacceptable toxic effectsMetastatic urothelial cancerObjective response rateThird-line therapy
2016
Safety and activity of nivolumab monotherapy in advanced and metastatic (A/M) gastric or gastroesophageal junction cancer (GC/GEC): Results from the CheckMate-032 study.
Le D, Bendell J, Calvo E, Kim J, Ascierto P, Sharma P, Ott P, Bono P, Jaeger D, Evans T, De Braud F, Chau I, Christensen O, Harbison C, Lin C, Janjigian Y. Safety and activity of nivolumab monotherapy in advanced and metastatic (A/M) gastric or gastroesophageal junction cancer (GC/GEC): Results from the CheckMate-032 study. Journal Of Clinical Oncology 2016, 34: 6-6. DOI: 10.1200/jco.2016.34.4_suppl.6.Peer-Reviewed Original ResearchObjective response rateNivolumab monotherapyOverall survivalPD-L1Negative tumorsPhase I/IIMedian overall survivalSingle-agent nivolumabTreatment-related deathsPD-L1 statusProgression-free survivalGastroesophageal junction cancerCell lung cancerFavorable safety profileRenal cell carcinomaAlkaline phosphatase levelsIgG4 monoclonal antibodyPrior regimensStable diseaseIntolerable toxicityMetastatic gastricPrimary endpointJunction cancerMedian durationObjective response
2013
Safety profile of recombinant poxviral TRICOM vaccines.
Kim J, Marte J, Singh N, Heery C, Madan R, Pazdur M, McMahon S, Rauckhorst M, Schlom J, Kantoff P, Gulley J. Safety profile of recombinant poxviral TRICOM vaccines. Journal Of Clinical Oncology 2013, 31: e16036-e16036. DOI: 10.1200/jco.2013.31.15_suppl.e16036.Peer-Reviewed Original ResearchThrombotic thrombocytopenic purpuraAdverse eventsPoxviral vaccinesSafety profileMetastatic castration-resistant prostate cancerRandomized phase II trialCastration-resistant prostate cancerEmergent adverse eventsMedian overall survivalPhase II trialPhase III trialsTherapeutic cancer vaccinesResistant prostate cancerFavorable safety profileGranulocyte-macrophage colony-stimulating factorProstate-specific antigenRoute of administrationColony-stimulating factorII trialIII trialsOverall survivalVaccine injectionImmune adjuvantsThrombocytopenic purpuraCancer vaccines