2023
Pembrolizumab and lenvatinib in recurrent ovarian clear cell carcinoma resistant to chemotherapy
McNamara B, Bellone S, Demirkiran C, Hartwich T, Santin A. Pembrolizumab and lenvatinib in recurrent ovarian clear cell carcinoma resistant to chemotherapy. Gynecologic Oncology Reports 2023, 48: 101218. PMID: 37325296, PMCID: PMC10265468, DOI: 10.1016/j.gore.2023.101218.Peer-Reviewed Original ResearchOvarian clear cell carcinomaClear cell carcinomaCombination of pembrolizumabCell carcinomaTreatment optionsRecurrent ovarian clear cell carcinomaWeeks of therapyCT scan findingsMild side effectsEffective treatment optionOral multikinase inhibitorNew treatment optionsDurable responsesMetastatic diseaseScan findingsPD-1Disease burdenTarget lesionsMultikinase inhibitorDrug combinationsSide effectsPembrolizumabLenvatinibMonoclonal antibodiesCarcinomaLenvatinib Plus Pembrolizumab in Previously Treated Advanced Endometrial Cancer: Updated Efficacy and Safety From the Randomized Phase III Study 309/KEYNOTE-775
Makker V, Colombo N, Herráez A, Monk B, Mackay H, Santin A, Miller D, Moore R, Baron-Hay S, Ray-Coquard I, Ushijima K, Yonemori K, Kim Y, Alia E, Sanli U, Bird S, Orlowski R, McKenzie J, Okpara C, Barresi G, Lorusso D. Lenvatinib Plus Pembrolizumab in Previously Treated Advanced Endometrial Cancer: Updated Efficacy and Safety From the Randomized Phase III Study 309/KEYNOTE-775. Journal Of Clinical Oncology 2023, 41: 2904-2910. PMID: 37058687, PMCID: PMC10414727, DOI: 10.1200/jco.22.02152.Peer-Reviewed Original ResearchConceptsObjective response rateProgression-free survivalPrimary end pointAdvanced endometrial cancerOverall survivalEndometrial cancerEnd pointMismatch repair-proficient tumorsClinical trial updateMetastatic endometrial cancerNew safety signalsSubgroups of interestManageable safetyPrespecified analysisTrial updateProficient tumorsClinical trialsSafety signalsPembrolizumabLenvatinibPhysician's choiceMultiple end pointsResponse rateSecondary analysisChemotherapyPembrolizumab with chemotherapy, with or without bevacizumab for persistent, recurrent, or metastatic cervical cancer
McNamara B, Chang Y, Mutlu L, Harold J, Santin A. Pembrolizumab with chemotherapy, with or without bevacizumab for persistent, recurrent, or metastatic cervical cancer. Expert Opinion On Biological Therapy 2023, 23: 227-233. PMID: 36800548, DOI: 10.1080/14712598.2023.2182679.Peer-Reviewed Original ResearchConceptsUse of pembrolizumabCervical cancerStandard chemotherapyMetastatic PD-L1Recurrent cervical cancerMetastatic cervical cancerNon-expressing tumorsVEGF therapyPD-L1Clinical efficacyGlobal morbidityPharmacologic propertiesChemotherapyPembrolizumabBevacizumabCancerRecurrentTreatmentTolerabilityFurther benefitImmunotherapyContraindicationsMorbidityEvidencePatients
2022
O018/#482 Updated safety of lenvatinib + pembrolizumab vs treatment of physician’s choice in patients with advanced endometrial cancer: study 309/keynote-775
Makker V, Colombo N, Herráez A, Monk B, Mackay H, Santin A, Miller D, Moore R, Ray-Coquard I, Shapira-Frommer R, Ushijima K, Yonemori K, Kim Y, Alia E, Sanli U, Xie R, Zale M, Mckenzie J, Barresi G, Lorusso D. O018/#482 Updated safety of lenvatinib + pembrolizumab vs treatment of physician’s choice in patients with advanced endometrial cancer: study 309/keynote-775. 2022, a11-a11. DOI: 10.1136/ijgc-2022-igcs.20.Peer-Reviewed Original Research525MO Updated efficacy and safety of lenvatinib (LEN) + pembrolizumab (pembro) vs treatment of physician’s choice (TPC) in patients (pts) with advanced endometrial cancer (aEC): Study 309/KEYNOTE-775
Makker V, Colombo N, Herraez A, Monk B, Mackay H, Santin A, Miller D, Moore R, Baron-Hay S, Ray-Coquard I, Shapira-Frommer R, Ushijima K, Yonemori K, Kim Y, Alia E, Sanli U, Huang J, McKenzie J, Barresi G, Lorusso D. 525MO Updated efficacy and safety of lenvatinib (LEN) + pembrolizumab (pembro) vs treatment of physician’s choice (TPC) in patients (pts) with advanced endometrial cancer (aEC): Study 309/KEYNOTE-775. Annals Of Oncology 2022, 33: s785-s786. DOI: 10.1016/j.annonc.2022.07.653.Peer-Reviewed Original Research20MO Time to deterioration in quality of life in patients (pts) with advanced endometrial cancer (aEC) treated with lenvatinib plus pembrolizumab (L+P) or treatment of physician’s choice (TPC)
Lorusso D, Colombo N, Herraez A, Santin A, Colomba E, Miller D, Fujiwara K, Pignata S, Baron-Hay S, Ray-Coquard I, Shapira-Frommer R, Kim Y, McCormack M, Massaad R, Nguyen A, Zhao Q, McKenzie J, Prabhu V, Makker V. 20MO Time to deterioration in quality of life in patients (pts) with advanced endometrial cancer (aEC) treated with lenvatinib plus pembrolizumab (L+P) or treatment of physician’s choice (TPC). Annals Of Oncology 2022, 33: s391-s392. DOI: 10.1016/j.annonc.2022.04.038.Peer-Reviewed Original ResearchLenvatinib Plus Pembrolizumab for Advanced Endometrial Cancer
Makker V, Colombo N, Herráez A, Santin A, Colomba E, Miller D, Fujiwara K, Pignata S, Baron-Hay S, Ray-Coquard I, Shapira-Frommer R, Ushijima K, Sakata J, Yonemori K, Kim Y, Guerra E, Sanli U, McCormack M, Smith A, Keefe S, Bird S, Dutta L, Orlowski R, Lorusso D. Lenvatinib Plus Pembrolizumab for Advanced Endometrial Cancer. Obstetrical & Gynecological Survey 2022, 77: 275-276. DOI: 10.1097/ogx.0000000000001032.Peer-Reviewed Original ResearchEndometrial cancerRecurrent endometrial cancerSecond-line treatmentAdvanced endometrial cancerPlatinum-based chemotherapyRecurrent endometrial carcinomaTyrosine kinase inhibitorsEndometrial carcinomaOptimal treatmentDisease progressionLimited efficacySingle agentKinase inhibitorsLenvatinibCancerTreatmentPembrolizumabLittle consensusChemotherapyCarcinomaProgressionLenvatinib plus Pembrolizumab for Advanced Endometrial Cancer
Makker V, Colombo N, Casado Herráez A, Santin AD, Colomba E, Miller DS, Fujiwara K, Pignata S, Baron-Hay S, Ray-Coquard I, Shapira-Frommer R, Ushijima K, Sakata J, Yonemori K, Kim YM, Guerra EM, Sanli UA, McCormack MM, Smith AD, Keefe S, Bird S, Dutta L, Orlowski RJ, Lorusso D. Lenvatinib plus Pembrolizumab for Advanced Endometrial Cancer. New England Journal Of Medicine 2022, 386: 437-448. PMID: 35045221, DOI: 10.1056/nejmoa2108330.Peer-Reviewed Original ResearchConceptsAdvanced endometrial cancerProgression-free survivalEndometrial cancerOverall survivalMedian progression-free survivalPlatinum-based chemotherapy regimenLonger progression-free survivalEnd pointBlinded independent central reviewMedian overall survivalPrimary end pointPhase 3 trialResponse Evaluation CriteriaPlatinum-based chemotherapyIndependent central reviewChemotherapy regimenAdverse eventsStandard therapyCentral reviewPembrolizumabGrade 3LenvatinibChemotherapyPhysician's choicePatients
2021
726MO Outcomes by histology and prior therapy with lenvatinib plus pembrolizumab vs treatment of physician’s choice in patients with advanced endometrial cancer (Study 309/KEYNOTE-775)
Colombo N, Lorusso D, Herráez A, Santin A, Colomba E, Miller D, Fujiwara K, Pignata S, Floquet A, Monk B, Banerjee S, Penson R, Kristeleit R, Fabbro M, Orlando M, Mackay H, Jensen E, Dutta L, Orlowski R, Makker V. 726MO Outcomes by histology and prior therapy with lenvatinib plus pembrolizumab vs treatment of physician’s choice in patients with advanced endometrial cancer (Study 309/KEYNOTE-775). Annals Of Oncology 2021, 32: s729-s730. DOI: 10.1016/j.annonc.2021.08.1169.Peer-Reviewed Original ResearchA phase II evaluation of pembrolizumab in recurrent microsatellite instability-high (MSI-H) endometrial cancer patients with Lynch-like versus MLH-1 methylated characteristics (NCT02899793)
Bellone S, Roque DM, Siegel ER, Buza N, Hui P, Bonazzoli E, Guglielmi A, Zammataro L, Nagarkatti N, Zaidi S, Lee J, Silasi D, Huang GS, Andikyan V, Damast S, Clark M, Azodi M, Schwartz PE, Tymon-Rosario J, Harold J, Mauricio D, Zeybek B, Menderes G, Altwerger G, Ratner E, Alexandrov LB, Iwasaki A, Kong Y, Song E, Dong W, Elvin J, Choi J, Santin AD. A phase II evaluation of pembrolizumab in recurrent microsatellite instability-high (MSI-H) endometrial cancer patients with Lynch-like versus MLH-1 methylated characteristics (NCT02899793). Annals Of Oncology 2021, 32: 1045-1046. PMID: 33932502, PMCID: PMC9465821, DOI: 10.1016/j.annonc.2021.04.013.Commentaries, Editorials and Letters
2020
Association of gene expression signatures and TMB with response to pembrolizumab (pembro) in patients (pts) with recurrent ovarian cancer (ROC) enrolled in KEYNOTE-100
Ledermann J, Shapira-Frommer R, Santin A, Lisyanskaya A, Pignata S, Vergote I, Raspagliesi F, Sonke G, Birrer M, Provencher D, Sehouli J, Colombo N, Martín A, Oaknin A, Saadatpour A, Kobie J, Jelinic P, Stein K, Matulonis U. Association of gene expression signatures and TMB with response to pembrolizumab (pembro) in patients (pts) with recurrent ovarian cancer (ROC) enrolled in KEYNOTE-100. Annals Of Oncology 2020, 31: s631-s632. DOI: 10.1016/j.annonc.2020.08.982.Peer-Reviewed Original Research
2019
Synergistic clinical efficacy of niraparib in combination with pembrolizumab in patients with recurrent platinum-resistant ovarian carcinoma
Tymon-Rosario J, Zeybek B, Han C, Santin AD. Synergistic clinical efficacy of niraparib in combination with pembrolizumab in patients with recurrent platinum-resistant ovarian carcinoma. Annals Of Translational Medicine 2019, 0: s308. PMID: 32016027, PMCID: PMC6976388, DOI: 10.21037/atm.2019.10.28.Peer-Reviewed Original ResearchPlatinum-based chemotherapyOvarian cancerInitial platinum-based chemotherapyPlatinum-resistant ovarian carcinomaGynecologic cancer deathStandard treatment regimenCancer respondMost patientsTreatment regimenClinical efficacyCancer deathOvarian carcinomaCommon causeDeath rateCancerPrecision medicineChemotherapyPatientsToxic effectsDeathPembrolizumabRegimenCarcinomaTherapyNiraparib
2018
LBA36 Association of PD-L1 expression and gene expression profiling with clinical response to pembrolizumab in patients with advanced recurrent ovarian cancer: Results from the phase II KEYNOTE-100 study
Ledermann J, Shapira-Frommer R, Santin A, Lisyanskaya A, Pignata S, Vergote I, Raspagliesi F, Sonke G, Birrer M, Provencher D, Sehouli J, Colombo N, González-Martín A, Oaknin A, Ottevanger P, Rudaitis V, Cristescu R, Kobie J, Ruman J, Matulonis U. LBA36 Association of PD-L1 expression and gene expression profiling with clinical response to pembrolizumab in patients with advanced recurrent ovarian cancer: Results from the phase II KEYNOTE-100 study. Annals Of Oncology 2018, 29: viii728. DOI: 10.1093/annonc/mdy424.043.Peer-Reviewed Original ResearchAntitumor activity and safety of pembrolizumab in patients with advanced recurrent ovarian cancer: Interim results from the phase 2 KEYNOTE-100 study.
Matulonis U, Shapira-Frommer R, Santin A, Lisyanskaya A, Pignata S, Vergote I, Raspagliesi F, Sonke G, Birrer M, Provencher D, Sehouli J, Colombo N, González-Martín A, Oaknin A, Ottevanger P, Rudaitis V, Katchar K, Wang Z, Ruman J, Ledermann J. Antitumor activity and safety of pembrolizumab in patients with advanced recurrent ovarian cancer: Interim results from the phase 2 KEYNOTE-100 study. Journal Of Clinical Oncology 2018, 36: 5511-5511. DOI: 10.1200/jco.2018.36.15_suppl.5511.Peer-Reviewed Original Research