2023
First-in-human study of ABBV-011, a seizure-related homolog protein 6 (SEZ6)–targeting antibody-drug conjugate, in patients with small cell lung cancer.
Morgensztern D, Ready N, Johnson M, Dowlati A, Choudhury N, Carbone D, Schaefer E, Arnold S, Puri S, Piotrowska Z, Hegde A, Chiang A, Iams W, Tolcher A, Nosaki K, Zha J, Li R, Hingorani P, Jeng E, Furqan M. First-in-human study of ABBV-011, a seizure-related homolog protein 6 (SEZ6)–targeting antibody-drug conjugate, in patients with small cell lung cancer. Journal Of Clinical Oncology 2023, 41: 3002-3002. DOI: 10.1200/jco.2023.41.16_suppl.3002.Peer-Reviewed Original ResearchSmall cell lung cancerTreatment-emergent adverse eventsClinical benefit rateMaximum tolerated doseAntibody-drug conjugatesCell lung cancerDose escalationMedian durationLung cancerProgrammed cell death-1 inhibitorRelapsed/refractory small cell lung cancerSmall cell lung cancer tumorsConfirmed objective response rateMedian duration of responseRecommended phase 2 doseModels of small cell lung cancerMedian duration of treatmentVeno-occlusive liver diseaseFirst-in-human studyAntitumor activityObjective response rateDose-limiting toxicityProgression-free survivalDuration of responseDuration of treatment
2022
KeyVibe-008: Randomized, phase 3 study of first-line vibostolimab plus pembrolizumab plus etoposide/platinum versus atezolizumab plus EP in extensive-stage small cell lung cancer.
Sands J, Reck M, Navarro A, Chiang A, Lu S, Peled N, Paz-Ares L, Kerr S, Takahashi T, Smolin A, Chen X, Zhao B, El-Osta H, Califano R. KeyVibe-008: Randomized, phase 3 study of first-line vibostolimab plus pembrolizumab plus etoposide/platinum versus atezolizumab plus EP in extensive-stage small cell lung cancer. Journal Of Clinical Oncology 2022, 40: tps8606-tps8606. DOI: 10.1200/jco.2022.40.16_suppl.tps8606.Peer-Reviewed Original ResearchExtensive-stage small-cell lung cancerEtoposide/platinumPatient-reported outcomesSmall cell lung cancerPhase 3 studyLung cancerRECIST v1.1ECOG PSDisease progressionBlinded independent central reviewNeurologic paraneoplastic syndromesUntreated ES-SCLCFirst-line pembrolizumabFirst-line treatmentInterstitial lung diseaseCell lung cancerDuration of responseT cell immunoreceptorIndependent central reviewWithdrawal of consentPretreatment tumor samplesNew anticancer treatmentsCare immunotherapyCTCAE v5.0Measurable disease
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