2020
Phase Ib/II open-label, randomized evaluation of 2L atezolizumab (atezo) + PEGPH20 versus control in MORPHEUS-pancreatic ductal adenocarcinoma (M-PDAC) and MORPHEUS-gastric cancer (M-GC).
Ko A, Lee J, ALSINA M, Ajani J, Bang Y, Chung H, Lacy J, Lopez C, Oh D, O'Reilly E, Siveke J, Allen S, Al-Sakaff N, Barak H, Lau J, Li S, Retiere A, Shemesh C, Zhang X, Kim K. Phase Ib/II open-label, randomized evaluation of 2L atezolizumab (atezo) + PEGPH20 versus control in MORPHEUS-pancreatic ductal adenocarcinoma (M-PDAC) and MORPHEUS-gastric cancer (M-GC). Journal Of Clinical Oncology 2020, 38: 4540-4540. DOI: 10.1200/jco.2020.38.15_suppl.4540.Peer-Reviewed Original ResearchSerious AEsPhase Ib/II trialPhase Ib/IIChemotherapy-free combinationsEarly efficacy signalsNew safety signalsDuration of responseSeparate randomized trialsRecombinant human hyaluronidaseGr 3Eligible ptsMedian PFSMetastatic PDACTumor hyaluronanCombination armMedian OSPrimary endpointII trialNab-paclitaxelPeripheral edemaEfficacy signalsExtracellular matrix modulatorsRandomized trialsPoor prognosisSafety profile
2018
RAINFALL: A randomized, double-blind, placebo-controlled phase III study of cisplatin (Cis) plus capecitabine (Cape) or 5FU with or without ramucirumab (RAM) as first-line therapy in patients with metastatic gastric or gastroesophageal junction (G-GEJ) adenocarcinoma.
Fuchs C, Shitara K, Di Bartolomeo M, Lonardi S, Al-Batran S, Van Cutsem E, Ilson D, Tabernero J, Chau I, Ducreux M, Mendez G, Molina Alavez A, Takahari D, Mansoor W, Lacy J, Gorbunova V, Ferry D, Lin J, Das M, Shah M. RAINFALL: A randomized, double-blind, placebo-controlled phase III study of cisplatin (Cis) plus capecitabine (Cape) or 5FU with or without ramucirumab (RAM) as first-line therapy in patients with metastatic gastric or gastroesophageal junction (G-GEJ) adenocarcinoma. Journal Of Clinical Oncology 2018, 36: 5-5. DOI: 10.1200/jco.2018.36.4_suppl.5.Peer-Reviewed Original ResearchProgression-free survivalFirst-line chemotherapyPrimary endpointITT populationOverall survivalPlacebo-controlled phase III studyECOG performance status 0Addition of ramucirumabIgG1 human monoclonal antibodiesPerformance status 0Powered secondary endpointSecond-line treatmentTreatment-naïve patientsFirst-line therapyNew safety signalsPhase III studyGastroesophageal junction adenocarcinomaSignificant clinical benefitHuman monoclonal antibodyImproved OSStatus 0Metastatic gastricSecondary endpointsAdverse eventsIII study