2022
A Phase 1 First-in-Human Study of FS118, a Tetravalent Bispecific Antibody Targeting LAG-3 and PD-L1 in Patients with Advanced Cancer and PD-L1 Resistance.
Yap T, LoRusso P, Wong D, Hu-Lieskovan S, Papadopoulos K, Holz J, Grabowska U, Gradinaru C, Leung K, Marshall S, Reader C, Russell R, Sainson R, Seal C, Shepherd C, Germaschewski F, Gliddon D, Stern O, Young L, Brewis N, Kayitalire L, Morrow M. A Phase 1 First-in-Human Study of FS118, a Tetravalent Bispecific Antibody Targeting LAG-3 and PD-L1 in Patients with Advanced Cancer and PD-L1 Resistance. Clinical Cancer Research 2022, 29: 888-898. PMID: 36342102, DOI: 10.1158/1078-0432.ccr-22-1449.Peer-Reviewed Original ResearchConceptsDisease control rateLAG-3PD-L1Advanced cancerOverall disease control rateDisease controlPeripheral effector cellsPhase 2 doseSerious adverse eventsPhase 1 studySoluble LAG-3Tetravalent bispecific antibodyPrior regimensStable diseaseDose expansionMetastatic settingAdverse eventsPartial responseEffector cellsClinical benefitControl rateSustained elevationTitration designPharmacodynamic activityHuman studies
2020
Association of an RNA signature (RS) with emergence of ICOS hi CD4 T cells and efficacy outcomes for the ICOS agonist vopratelimab (vopra) and nivolumab (nivo) in patients (pts) on the ICONIC trial.
Yap T, Gainor J, Burris H, Kummar S, Pachynski R, Callahan M, LoRusso P, Tykodi S, Gibney G, Falchook G, Rahma O, Seiwert T, Papadopoulos K, Mier J, Hashambhoy-Ramsay Y, Felitsky D, Lee D, McGrath L, Harvey C, Hooper E. Association of an RNA signature (RS) with emergence of ICOS hi CD4 T cells and efficacy outcomes for the ICOS agonist vopratelimab (vopra) and nivolumab (nivo) in patients (pts) on the ICONIC trial. Journal Of Clinical Oncology 2020, 38: 14-14. DOI: 10.1200/jco.2020.38.5_suppl.14.Peer-Reviewed Original ResearchCD4 T cellsCD4 T effector cellsT effector cellsT cellsRNA signatureRECIST responseClinical outcomesEffector cellsTumor biopsiesPre-treatment tumor biopsiesCD4 T cell populationBaseline tumor biopsiesPD-L1 TPSPD-1 inhibitorsAdvanced solid tumorsRetrospective subset analysisImmune cell infiltrationPotential predictive biomarkersT cell populationsPD-L1 IHCActivated T cellsBaseline tumorEfficacy outcomesPD-L1Combo therapy