2023
Atezolizumab Plus PEGPH20 Versus Chemotherapy in Advanced Pancreatic Ductal Adenocarcinoma and Gastric Cancer: MORPHEUS Phase Ib/II Umbrella Randomized Study Platform
Ko A, Kim K, Siveke J, Lopez C, Lacy J, O'Reilly E, Macarulla T, Manji G, Lee J, Ajani J, Alsina Maqueda M, Rha S, Lau J, Al-Sakaff N, Allen S, Lu D, Shemesh C, Gan X, Cha E, Oh D. Atezolizumab Plus PEGPH20 Versus Chemotherapy in Advanced Pancreatic Ductal Adenocarcinoma and Gastric Cancer: MORPHEUS Phase Ib/II Umbrella Randomized Study Platform. The Oncologist 2023, 28: 553-e472. PMID: 36940261, PMCID: PMC10243783, DOI: 10.1093/oncolo/oyad022.Peer-Reviewed Original ResearchConceptsObjective response ratePancreatic ductal adenocarcinomaGrade 3/4 adverse eventsGrade 5 adverse eventsAdverse eventsGastric cancerDuctal adenocarcinomaPhase Ib/II trialAdvanced pancreatic ductal adenocarcinomaLimited clinical activitySafety of atezolizumabRecombinant human hyaluronidaseEligible patientsVersus ChemotherapyII trialPrimary endpointRECIST 1.1Early efficacySafety profileAtezolizumabClinical activitySafety signalsPEGPH20Response rateHuman hyaluronidase
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 profilePhase Ib/II open-label, randomized evaluation of 2L atezolizumab (atezo) + BL-8040 versus control in MORPHEUS-pancreatic ductal adenocarcinoma (M-PDAC) and MORPHEUS-gastric cancer (M-GC).
Oh D, Ajani J, Bang Y, Chung H, Lacy J, Lee J, Macarulla T, Manji G, O'Reilly E, Allen S, Al-Sakaff N, Barak H, Patel J, Pintoffl J, Shemesh C, Zhang W, Zhang X, Chau I. Phase Ib/II open-label, randomized evaluation of 2L atezolizumab (atezo) + BL-8040 versus control in MORPHEUS-pancreatic ductal adenocarcinoma (M-PDAC) and MORPHEUS-gastric cancer (M-GC). Journal Of Clinical Oncology 2020, 38: 712-712. DOI: 10.1200/jco.2020.38.4_suppl.712.Peer-Reviewed Original ResearchControl armPhase Ib/IIEarly efficacy signalsInjection-related reactionsImmune-mediated effectsSeparate randomized trialsHigh-affinity antagonistEvaluable ptsMetastatic PDACPrimary endpointRECIST 1.1II trialEfficacy signalsRandomized trialsSafety profileAtezoDuctal adenocarcinomaPK dataRandomized EvaluationCancerGr 3PDACTrialsWkEfficacy