2021
Sapanisertib, 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 characteristics
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