2024
Pembrolizumab Plus mFOLFOX7 or FOLFIRI for Microsatellite Stable/Mismatch Repair-Proficient Metastatic Colorectal Cancer: KEYNOTE-651 Cohorts B and D
Kim R, Tehfe M, Kavan P, Chaves J, Kortmansky J, Chen E, Lieu C, Wong L, Fakih M, Spencer K, Zhao Q, Predoiu R, Li C, Leconte P, Adelberg D, Chiorean E. Pembrolizumab Plus mFOLFOX7 or FOLFIRI for Microsatellite Stable/Mismatch Repair-Proficient Metastatic Colorectal Cancer: KEYNOTE-651 Cohorts B and D. Clinical Colorectal Cancer 2024, 23: 118-127.e6. PMID: 38762348, DOI: 10.1016/j.clcc.2024.03.001.Peer-Reviewed Original ResearchMetastatic colorectal cancerObjective response rateCohort BCohort DAdverse eventsColorectal cancerT-cell-inflamed gene expression profileInvestigator-assessed objective response ratePD-L1 combined positive scoreTreatment-related adverse eventsResponse rateCombined positive scoreDose-limiting toxicityMedian follow-upTumor mutational burdenDecreased neutrophil countPrimary end pointMismatch repair-proficientStandard of careBiomarker analysisMethods PatientsRECIST v1.1PD-L1HER2 expressionMutational burden
2022
Pembrolizumab (pembro) plus binimetinib (bini) with or without chemotherapy (chemo) for metastatic colorectal cancer (mCRC): Results from KEYNOTE-651 cohorts A, C, and E.
Chen E, Kavan P, Tehfe M, Kortmansky J, Sawyer M, Chiorean E, Lieu C, Polite B, Wong L, Fakih M, Spencer K, Chaves J, Li C, Carpenter D, Leconte P, Kim R. Pembrolizumab (pembro) plus binimetinib (bini) with or without chemotherapy (chemo) for metastatic colorectal cancer (mCRC): Results from KEYNOTE-651 cohorts A, C, and E. Journal Of Clinical Oncology 2022, 40: 3573-3573. DOI: 10.1200/jco.2022.40.16_suppl.3573.Peer-Reviewed Original ResearchMetastatic colorectal cancerDose-limiting toxicityCohort ACohort ECohort CEvaluable ptsMicrosatellite stableDose levelsEnd pointDose-finding phasePrimary end pointSecondary end pointsKRAS mutation statusTotal PtCohort A.RECIST v1.1Data cutoffMulticenter trialDose escalationColorectal cancerMedian studyPembroDose reductionLimited efficacyTRAEsPembrolizumab (pembro) plus mFOLFOX7 or FOLFIRI for metastatic colorectal cancer (CRC) in KEYNOTE-651: Long-term follow-up of cohorts B and D.
Kim R, Tehfe M, Kavan P, Chaves J, Kortmansky J, Chen E, Lieu C, Wong L, Fakih M, Spencer K, Zhao Q, Predoiu R, Li C, Carpenter D, Leconte P, Chiorean E. Pembrolizumab (pembro) plus mFOLFOX7 or FOLFIRI for metastatic colorectal cancer (CRC) in KEYNOTE-651: Long-term follow-up of cohorts B and D. Journal Of Clinical Oncology 2022, 40: 3521-3521. DOI: 10.1200/jco.2022.40.16_suppl.3521.Peer-Reviewed Original ResearchCohort BColorectal cancerCohort DPMMR colorectal cancerRECIST v1.1End pointExploratory end pointsPD-L1 dataSingle-arm cohortAntitumor activityManageable safety profileMetastatic colorectal cancerPrimary end pointSecondary end pointsNew safety signalsAntitumor immune responseCombination of chemotherapyKRAS mutation statusGreater antitumor activityData cutoffStarting doseNeutrophil countPrior linesInvestigator reviewSafety profile
2019
Phase IB/II Randomized Study of FOLFIRINOX Plus Pegylated Recombinant Human Hyaluronidase Versus FOLFIRINOX Alone in Patients With Metastatic Pancreatic Adenocarcinoma: SWOG S1313
Ramanathan RK, McDonough SL, Philip PA, Hingorani SR, Lacy J, Kortmansky JS, Thumar J, Chiorean EG, Shields AF, Behl D, Mehan PT, Gaur R, Seery T, Guthrie KA, Hochster HS. Phase IB/II Randomized Study of FOLFIRINOX Plus Pegylated Recombinant Human Hyaluronidase Versus FOLFIRINOX Alone in Patients With Metastatic Pancreatic Adenocarcinoma: SWOG S1313. Journal Of Clinical Oncology 2019, 37: jco.18.01295. PMID: 30817250, PMCID: PMC6494359, DOI: 10.1200/jco.18.01295.Peer-Reviewed Original ResearchConceptsMetastatic pancreatic cancerMedian overall survivalCombination armOverall survivalHazard ratioControl armPhase II open-label studyTreatment-related grade 3Adequate organ functionPhase II dosageOpen-label studyPrimary end pointMetastatic pancreatic adenocarcinomaOS hazard ratioHA statusDose-finding studyInterim futility analysisRecombinant human hyaluronidaseEnoxaparin prophylaxisThromboembolic eventsPerformance statusProlong survivalRandomized studyFutility analysisGood PS