2021
A Phase I Study of APX005M and Cabiralizumab with or without Nivolumab in Patients with Melanoma, Kidney Cancer, or Non–Small Cell Lung Cancer Resistant to Anti-PD-1/PD-L1
Weiss SA, Djureinovic D, Jessel S, Krykbaeva I, Zhang L, Jilaveanu L, Ralabate A, Johnson B, Levit NS, Anderson G, Zelterman D, Wei W, Mahajan A, Trifan O, Bosenberg M, Kaech SM, Perry CJ, Damsky W, Gettinger S, Sznol M, Hurwitz M, Kluger HM. A Phase I Study of APX005M and Cabiralizumab with or without Nivolumab in Patients with Melanoma, Kidney Cancer, or Non–Small Cell Lung Cancer Resistant to Anti-PD-1/PD-L1. Clinical Cancer Research 2021, 27: 4757-4767. PMID: 34140403, PMCID: PMC9236708, DOI: 10.1158/1078-0432.ccr-21-0903.Peer-Reviewed Original ResearchConceptsAnti-PD-1/PD-L1Non-small cell lung cancerCell lung cancerRenal cell carcinomaPD-L1Lung cancerDisease progressionCommon treatment-related adverse eventsPD-1/PD-L1 inhibitorsTreatment-related adverse eventsPhase 2 doseSubstantial clinical challengeUnconfirmed partial responseDose-limiting toxicityPD-L1 inhibitorsPhase I trialDose-escalation designPro-inflammatory cytokinesMultiple tumor typesAsymptomatic elevationStable diseaseIntolerable toxicityAdverse eventsMedian durationPartial response
2017
Atezolizumab (atezo) plus platinum-based chemotherapy (chemo) in non-small cell lung cancer (NSCLC): Update from a phase Ib study.
Liu S, Camidge D, Gettinger S, Giaccone G, Heist R, Hodi F, Ready N, Zhang W, Wallin J, Funke R, Waterkamp D, Foster P, Iizuka K, Powderly J. Atezolizumab (atezo) plus platinum-based chemotherapy (chemo) in non-small cell lung cancer (NSCLC): Update from a phase Ib study. Journal Of Clinical Oncology 2017, 35: 9092-9092. DOI: 10.1200/jco.2017.35.15_suppl.9092.Peer-Reviewed Original ResearchNon-small cell lung cancerOverall response rateAdverse eventsAnti-programmed death ligand 1 antibodyAdvanced non-small cell lung cancerMetastatic non-small cell lung cancerCommon treatment-related grade 3Terms of ORRConfirmed overall response rateGrade 5 adverse eventsStandard first-line therapyTreatment-related grade 3Death ligand 1 antibodyPhase Ib studyTumor antigen releaseFirst-line therapyPhase III studyPlatinum-based chemotherapyCell lung cancerActionable gene alterationsMulti-arm studiesMultiple tumor typesMedian PFSNSCLC ptsPrior chemoNivolumab (N) plus ipilimumab (I) as first-line (1L) treatment for advanced (adv) NSCLC: 2-yr OS and long-term outcomes from CheckMate 012.
Goldman J, Antonia S, Gettinger S, Borghaei H, Brahmer J, Ready N, Gerber D, Chow L, Juergens R, Shepherd F, Laurie S, Geese W, Li A, Li X, Hellmann M. Nivolumab (N) plus ipilimumab (I) as first-line (1L) treatment for advanced (adv) NSCLC: 2-yr OS and long-term outcomes from CheckMate 012. Journal Of Clinical Oncology 2017, 35: 9093-9093. DOI: 10.1200/jco.2017.35.15_suppl.9093.Peer-Reviewed Original ResearchPD-L1 expressionComplete responsePD-L1Long-term OS benefitPD-L1 tumor expressionStage IIIB/IVTumor PD-L1 expressionChemotherapy-naive NSCLCECOG PS 0Experienced grade 3IIIB/IVManageable safety profileFirst-line treatmentPhase 1 studyLong-term survivorsLong-term outcomesMultiple tumor typesExploratory endpointsOS benefitAdvanced NSCLCPrimary endpointSecondary endpointsPS 0Unacceptable toxicityConsent withdrawal