2023
First-in-class oral innate immune activator BXCL701 combined with pembrolizumab in patients with metastatic, castration-resistant prostate cancer (mCRPC) of small cell neuroendocrine (SCNC) phenotype: Phase 2a final results.
Aggarwal R, Zhang J, Zhu X, Monk P, Jones R, Linch M, Costin D, De Bono J, Karsh L, Petrylak D, Borderies P, Deshpande R, Hafeez A, O'Neill V, Tagawa S. First-in-class oral innate immune activator BXCL701 combined with pembrolizumab in patients with metastatic, castration-resistant prostate cancer (mCRPC) of small cell neuroendocrine (SCNC) phenotype: Phase 2a final results. Journal Of Clinical Oncology 2023, 41: 176-176. DOI: 10.1200/jco.2023.41.6_suppl.176.Peer-Reviewed Original ResearchEvaluable patientsMedian durationDay 1Castration-resistant prostate cancerOral small-molecule inhibitorEncouraging anti-tumor activityImmune-related AEPrime immune cellsAcceptable safety profilePhase 2 studyDurability of responsePlatinum-based chemotherapyImmune effector cellsStandard of careAnti-tumor activityComposite respondersRECIST respondersBID dosingCheckpoint inhibitorsMCRPC patientsPrimary endpointRECIST 1.1Acceptable tolerabilityAdverse eventsCytotoxic chemotherapy
2022
Efficacy and safety of pembrolizumab in metastatic urothelial carcinoma: results from KEYNOTE-045 and KEYNOTE-052 after up to 5 years of follow-up ☆
Balar A, Castellano D, Grivas P, Vaughn D, Powles T, Vuky J, Fradet Y, Lee J, Fong L, Vogelzang N, Climent M, Necchi A, Petrylak D, Plimack E, Xu J, Imai K, Moreno B, Bellmunt J, de Wit R, O’Donnell P. Efficacy and safety of pembrolizumab in metastatic urothelial carcinoma: results from KEYNOTE-045 and KEYNOTE-052 after up to 5 years of follow-up ☆. Annals Of Oncology 2022, 34: 289-299. PMID: 36494006, DOI: 10.1016/j.annonc.2022.11.012.Peer-Reviewed Original ResearchConceptsMetastatic urothelial carcinomaBlinded independent central reviewCisplatin-ineligible patientsObjective response rateRECIST version 1.1Years of followUrothelial carcinomaKEYNOTE-045KEYNOTE-052Primary endpointMost treatment-related adverse eventsResponse rateSurvival rateConfirmed objective response rateTreatment-related adverse eventsProgression-free survival ratesFurther safety concernsPlatinum-containing chemotherapyFirst-line therapyImmune checkpoint inhibitorsNew safety signalsProgression-free survivalDurability of responseFirst-line pembrolizumabOverall survival rate