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 hyaluronidaseEffect of a MUC5AC Antibody (NPC-1C) Administered With Second-Line Gemcitabine and Nab-Paclitaxel on the Survival of Patients With Advanced Pancreatic Ductal Adenocarcinoma
Huffman B, Mallick A, Horick N, Wang-Gillam A, Hosein P, Morse M, Beg M, Murphy J, Mavroukakis S, Zaki A, Schlechter B, Sanoff H, Manz C, Wolpin B, Arlen P, Lacy J, Cleary J. Effect of a MUC5AC Antibody (NPC-1C) Administered With Second-Line Gemcitabine and Nab-Paclitaxel on the Survival of Patients With Advanced Pancreatic Ductal Adenocarcinoma. JAMA Network Open 2023, 6: e2249720. PMID: 36602796, PMCID: PMC9856813, DOI: 10.1001/jamanetworkopen.2022.49720.Peer-Reviewed Original ResearchConceptsAdvanced pancreatic ductal adenocarcinomaPancreatic ductal adenocarcinomaObjective response rateProgression-free survivalSecond-line treatmentNab-paclitaxelOverall survivalClinical trialsDuctal adenocarcinomaRandomized phase II clinical trialMedian progression-free survivalGemcitabine/nab-paclitaxelCox proportional hazards analysisEnd pointPhase II clinical trialChemotherapy dose reductionsFirst-line FOLFIRINOXSecond-line gemcitabineMedian overall survivalPrimary end pointSecondary end pointsProportional hazards analysisSurvival of patientsLow performance statusPretreatment clinical variables
2020
HALO 109-301: A randomized, double-blind, placebo-controlled, phase 3 study of pegvorhyaluronidase alfa (PEGPH20) + nab-paclitaxel/gemcitabine (AG) in patients (pts) with previously untreated hyaluronan (HA)-high metastatic pancreatic ductal adenocarcinoma (mPDA).
Tempero M, Van Cutsem E, Sigal D, Oh D, Fazio N, Macarulla T, Hitre E, Hammel P, Hendifar A, Bates S, Li C, De La Fouchardiere C, Heinemann V, Maraveyas A, Bahary N, Layos L, Sahai V, Zheng L, Lacy J, Bullock A. HALO 109-301: A randomized, double-blind, placebo-controlled, phase 3 study of pegvorhyaluronidase alfa (PEGPH20) + nab-paclitaxel/gemcitabine (AG) in patients (pts) with previously untreated hyaluronan (HA)-high metastatic pancreatic ductal adenocarcinoma (mPDA). Journal Of Clinical Oncology 2020, 38: 638-638. DOI: 10.1200/jco.2020.38.4_suppl.638.Peer-Reviewed Original ResearchMetastatic pancreatic ductal adenocarcinomaObjective response rateProgression-free survivalPhase 3 studyOverall survivalAdverse eventsTumor microenvironmentHazard ratioNab-paclitaxel/gemcitabineRandomized phase 2 studyMedian progression-free survivalIntolerable adverse eventsMedian overall survivalPhase 2 studyPancreatic ductal adenocarcinomaPegvorhyaluronidase alfaProphylactic enoxaparinRECIST v1.1Primary endpointSecondary endpointsTE eventsBaseline characteristicsMusculoskeletal eventsThromboembolism riskClinical outcomes
2019
Antitumor activity of margetuximab (M) plus pembrolizumab (P) in patients (pts) with advanced HER2+ (IHC3+) gastric carcinoma (GC).
Catenacci D, Lim K, Uronis H, Kang Y, Ng M, Gold P, Enzinger P, Lee K, Lacy J, Park H, Yen J, Odegaard J, Franovic A, Baughman J, Wynter-Horton A, Chen F, Moore P, Wu T, Davidson-Moncada J, Bang Y. Antitumor activity of margetuximab (M) plus pembrolizumab (P) in patients (pts) with advanced HER2+ (IHC3+) gastric carcinoma (GC). Journal Of Clinical Oncology 2019, 37: 65-65. DOI: 10.1200/jco.2019.37.4_suppl.65.Peer-Reviewed Original ResearchDisease control rateObjective response ratePD-L1 expressionGastric carcinomaHER2 expressionHigh PD-L1 expressionStandard first-line therapyTumor PD-L1 expressionChemo-free regimenDrug-related SAEsFirst-line therapyProgression-free survivalAnti-HER2 agentsAutoimmune hepatitisExploratory endpointsMedian overallDiabetic ketoacidosisAcceptable tolerabilityAdvanced HER2Adverse eventsPD-L1Control rateIHC 3Grade 3Archival tumors