2022
A phase 1/2 study of the highly selective EGFR inhibitor, BLU-701, in patients with EGFR-mutant non–small cell lung cancer (NSCLC).
Spira A, Spigel D, Camidge D, De Langen A, Kim T, Goto K, Elamin Y, Shum E, Reckamp K, Rotow J, Goldberg S, Gadgeel S, Leal T, Albayya F, Fitzpatrick S, Louie-Gao M, Parepally J, Zalutskaya A, Yu H. A phase 1/2 study of the highly selective EGFR inhibitor, BLU-701, in patients with EGFR-mutant non–small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2022, 40: tps9142-tps9142. DOI: 10.1200/jco.2022.40.16_suppl.tps9142.Peer-Reviewed Original ResearchNon-small cell lung cancerEGFRm non-small cell lung cancerTyrosine kinase inhibitorsOverall response ratePrimary endpointEastern Cooperative Oncology Group performance status 0EGFR-mutant non-small cell lung cancerPhase 1 dose escalationPhase 2 primary endpointOral tyrosine kinase inhibitorGeneration tyrosine kinase inhibitorsResistance mutationsEGFR T790M mutationDisease control rateKey exclusion criteriaPerformance status 0Phase 1/2 studyPhase 2 doseProgression-free survivalPlatinum-based chemotherapyCell lung cancerDuration of responseCentral nervous system activityKey inclusion criteriaPK/pharmacodynamics
2021
Trial in progress: A phase 1b study of sotorasib, a specific and irreversible KRASG12C inhibitor, as monotherapy in non-small cell lung cancer (NSCLC) with brain metastasis and in combination with other anticancer therapies in advanced solid tumors (CodeBreaK 101).
Hong D, Strickler J, Fakih M, Falchook G, Li B, Durm G, Burns T, Ramalingam S, Goldberg S, Frank R, Marrone K, Shu C, Gandara D, Soman N, Henary H, Govindan R. Trial in progress: A phase 1b study of sotorasib, a specific and irreversible KRASG12C inhibitor, as monotherapy in non-small cell lung cancer (NSCLC) with brain metastasis and in combination with other anticancer therapies in advanced solid tumors (CodeBreaK 101). Journal Of Clinical Oncology 2021, 39: tps2669-tps2669. DOI: 10.1200/jco.2021.39.15_suppl.tps2669.Peer-Reviewed Original ResearchNon-small cell lung cancerCombination regimensSolid tumorsG12C mutationKRAS p.Treatment-related adverse eventsAntitumor efficacyPhase 1b studyPrior systemic therapyOpen-label studyAdvanced solid tumorsDurable clinical benefitDose-limiting toxicityKey eligibility criteriaMetastatic solid tumorsAnticancer therapyCell lung cancerOncogenic driver mutationsCombination cohortManageable toxicityDose expansionPrimary endpointSecondary endpointsTolerability profileAdverse events
2019
RBTT-07. A PHASE 2 TRIAL OF PEMBROLIZUMAB AND BEVACIZUMAB IN MELANOMA BRAIN MET PATIENTS
Kluger H, Forsyth P, Khushalani N, Eroglu Z, Sznol M, Tran T, Jilaveanu L, Cohen J, Hegde U, Wei W, Mahajan A, Goldberg S, Chiang V, Weiss S. RBTT-07. A PHASE 2 TRIAL OF PEMBROLIZUMAB AND BEVACIZUMAB IN MELANOMA BRAIN MET PATIENTS. Neuro-Oncology 2019, 21: vi220-vi220. PMCID: PMC6847787, DOI: 10.1093/neuonc/noz175.919.Peer-Reviewed Original ResearchVEGF inhibitorsPrimary endpointPD-1/PD-L1Anti-PD-1 activityGrade 3 ALT elevationPre-specified primary endpointPhase 2 studyPhase 2 trialUnconfirmed PRALT elevationDiverticular perforationMetS patientsCerebral edemaPD-L1Wound dehiscencePembroToxicity profileEdemaFurther studiesPromising activityEndpointBRAFmtPembrolizumabMucositisULN