2022
A phase Ia/Ib, dose-escalation/expansion study of BI 907828 in combination with BI 754091 (ezabenlimab) and BI 754111 in patients (pts) with advanced solid tumors.
Yamamoto N, Hafez N, Tolcher A, Teufel M, Geng J, Svensson L, Lahmar M, Gounder M. A phase Ia/Ib, dose-escalation/expansion study of BI 907828 in combination with BI 754091 (ezabenlimab) and BI 754111 in patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2022, 40: 3095-3095. DOI: 10.1200/jco.2022.40.16_suppl.3095.Peer-Reviewed Original ResearchDose-limiting toxicityImmune checkpoint inhibitorsDoublet combinationsCheckpoint inhibitorsPrimary endpointPhase Ia/Ib studySolid tumorsManageable safety profileMDM2-p53 antagonistsProgression-free survivalAdvanced solid tumorsBiliary tract carcinomaMetastatic solid tumorsSoft tissue sarcomasAnti-tumor effectsWild-type cancersAnti-tumor activityLogistic regression modelsPhase IaMultiple tumor typesG3 anemiaG3 neutropeniaG4 thrombocytopeniaIA/IBMurine double minuteKRYSTAL-1: Updated activity and safety of adagrasib (MRTX849) in patients (Pts) with unresectable or metastatic pancreatic cancer (PDAC) and other gastrointestinal (GI) tumors harboring a KRASG12C mutation.
Bekaii-Saab T, Spira A, Yaeger R, Buchschacher G, McRee A, Sabari J, Johnson M, Barve M, Hafez N, Velastegui K, Christensen J, Kheoh T, Der-Torossian H, Rybkin I. KRYSTAL-1: Updated activity and safety of adagrasib (MRTX849) in patients (Pts) with unresectable or metastatic pancreatic cancer (PDAC) and other gastrointestinal (GI) tumors harboring a KRASG12C mutation. Journal Of Clinical Oncology 2022, 40: 519-519. DOI: 10.1200/jco.2022.40.4_suppl.519.Peer-Reviewed Original ResearchDisease control rateKRAS G12C mutationProgression-free survivalPartial responseGI tumorsClinical activityG12C mutationPancreatic cancerSolid tumorsMedian progression-free survivalTreatment-related adverse eventsGrade 3/4 eventsGrade 5 eventsPhase 1/2 studyAdvanced solid tumorsMetastatic pancreatic cancerMetastatic solid tumorsEncouraging clinical activityPhase 2 cohortExtensive tissue distributionKRAS G12C inhibitorsFavorable pharmacokinetic propertiesEvaluable ptsKRASG12C mutationData cutoff
2020
A phase Ia/Ib, dose-escalation/expansion study of BI 907828 in combination with BI 754091 and BI 754111 in patients (pts) with advanced solid tumors.
Tolcher A, Hafez N, Yamamoto N, Park J, Grempler R, Lucarelli A, Lahmar M, Wang B, Gounder M. A phase Ia/Ib, dose-escalation/expansion study of BI 907828 in combination with BI 754091 and BI 754111 in patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2020, 38: tps3660-tps3660. DOI: 10.1200/jco.2020.38.15_suppl.tps3660.Peer-Reviewed Original ResearchDose-limiting toxicityProgression-free survivalPrimary endpointSecondary endpointsPhase IbPhase Ia/Ib studySolid tumorsAnti-PD-1 antibodyMeasurable target lesionsAdvanced solid tumorsMaximum-tolerated doseFirst treatment cycleMetastatic solid tumorsAnti-LAG-3 antibodyTP53 wild-type tumorsAnti-tumor effectsWild-type cancersWild-type tumorsTP53 mutation statusLogistic regression modelsMultiple tumor typesEvaluable ptsIA/IBMurine double minutePFS rates