O008/#785 A multicenter, open-label, randomized, phase 3 study to compare the efficacy and safety of lenvatinib in combination with pembrolizumab vs treatment of physician’s choice in patients with advanced endometrial cancer: study 309/keynote-775
Makker V, Colombo N, Herráez A, Santin A, Colomba E, Miller D, Fujiwara K, Pignata S, Baron-Hay S, Ray-Coquard I, Shapira R, Ushijima K, Sakata J, Yonemori K, Kim Y, Guerra E, Sanli U, Mccormack M, Huang J, Smith A. O008/#785 A multicenter, open-label, randomized, phase 3 study to compare the efficacy and safety of lenvatinib in combination with pembrolizumab vs treatment of physician’s choice in patients with advanced endometrial cancer: study 309/keynote-775. International Journal Of Gynecological Cancer 2021, 31: a4-a5. DOI: 10.1136/ijgc-2021-igcs.8.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsAdvanced endometrial cancerObjective response rateEndometrial cancerPhysician's choiceCommon treatment-emergent adverse eventsPrior platinum-based chemotherapy regimenPhase 3 study resultsPlatinum-based chemotherapy regimenPrior platinum-based chemotherapyDNA mismatch repair (MMR) statusBlinded independent central reviewPhase 1b/2 studySafety of lenvatinibKey secondary endpointMedian treatment durationAdvanced endometrial carcinomaPhase 3 studyPlatinum-based chemotherapyIndependent central reviewPlatinum-based therapyMismatch repair statusEligible ptsRECIST v1.1Adjuvant settingO002/#43 Randomized phase 3 study of lenvatinib plus pembrolizumab for advanced endometrial cancer (aec): subgroup analysis of patients with DNA mismatch repair deficient (DMMR) tumors
Makker V, Colombo N, Herráez A, Santin A, Colomba E, Miller D, Fujiwara K, Pignata S, Banerjee S, Monk B, Ushijima K, Penson R, Kristeleit R, Fabbro M, Orlando M, Mackay H, Ren M, Orlowski R, Dutta L, Lorusso D. O002/#43 Randomized phase 3 study of lenvatinib plus pembrolizumab for advanced endometrial cancer (aec): subgroup analysis of patients with DNA mismatch repair deficient (DMMR) tumors. International Journal Of Gynecological Cancer 2021, 31: a1-a2. DOI: 10.1136/ijgc-2021-igcs.2.Peer-Reviewed Original ResearchTPC groupDNA mismatch repair deficient tumorsPrior platinum-based chemotherapy regimenMismatch repair-proficient tumorsPlatinum-based chemotherapy regimenTreatment-emergent adverse eventsRandomized phase 3 studyMismatch repair-deficient tumorsBlinded independent central reviewManageable safety profileAdvanced endometrial cancerPhase 3 studyPlatinum-based therapyIndependent central reviewRepair-deficient tumorsRECIST v1.1Chemotherapy regimenAdverse eventsEndometrial cancerProficient tumorsCentral reviewDMMR patientsSafety profileSubgroup analysisPatients