2020
359 AMG 757, a half-life extended bispecific T-cell engager (BiTE®) immune therapy against DLL3 in SCLC: phase 1 interim results
Borghaei H, Boyer M, Johnson M, Govindan R, Rodrigues L, Blackhall F, Boosman R, Champiat S, Hummel H, Lai W, Udagawa H, Chiang A, Dowlati A, Hann C, Salgia R, Vokes E, Minocha M, Hashemi-Sadraei N, Shetty A, Smit M, Yang H, Owonikoko T. 359 AMG 757, a half-life extended bispecific T-cell engager (BiTE®) immune therapy against DLL3 in SCLC: phase 1 interim results. Journal For ImmunoTherapy Of Cancer 2020, 8: a384-a384. DOI: 10.1136/jitc-2020-sitc2020.0359.Peer-Reviewed Original ResearchDelta-like ligand 3Small cell lung cancerCytokine release syndromeAdverse eventsImmune therapyPD-1/PD-L1 treatmentDose levelsRefractory small cell lung cancerOngoing phase 1 studiesTreatment-emergent adverse eventsTumor cellsCommon adverse eventsMedian prior linesMedian treatment durationPD-L1 treatmentPlatinum-based regimenAcceptable safety profileDose-proportional increaseFurther dose escalationPhase 1 studyCell lung cancerDuration of responseEthics BoardAnti-tumor activityECOG PS
2014
1473P Phase 1B Trial of Anti-Notch 2/3 Antibody Omp-59R5 in Combination with Etoposide and Cisplatin (Ep) in Patients (Pts) with Untreated Extensive-Stage Small-Cell Lung Cancer (Ed-Sclc): the Pinnacle Study
Pietanza M, Spira A, Jotte R, Gadgeel S, Mita A, Liu S, Gluck W, Kalemkerian G, Chiang A, Hart L, Kapoun A, Xu L, Hill D, Zhou L, Dupont J, Spigel D. 1473P Phase 1B Trial of Anti-Notch 2/3 Antibody Omp-59R5 in Combination with Etoposide and Cisplatin (Ep) in Patients (Pts) with Untreated Extensive-Stage Small-Cell Lung Cancer (Ed-Sclc): the Pinnacle Study. Annals Of Oncology 2014, 25: iv514. DOI: 10.1093/annonc/mdu355.11.Peer-Reviewed Original ResearchDose-limiting toxicityAnti-tumor activityDay 1Untreated extensive stage small cell lung cancerExtensive-stage small-cell lung cancerMain dose-limiting toxicitySmall cell lung cancerGrade 3 diarrheaGrade 3 nauseaPhase 2 partPhase 1b trialPK/pharmacodynamicsED-SCLCSCLC xenograftsDose cohortsRECIST 1.1Peripheral edemaUnacceptable toxicityAdverse eventsSupportive carePreliminary efficacyLung cancerDisease progressionEfficacy dataIgG2 antibodies