2024
Comprehensive characterization of ERBB2 genomic alterations inlung cancer.
El Zarif T, Stockhammer P, Schillo J, Goldberg S, Politi K, Grant M. Comprehensive characterization of ERBB2 genomic alterations inlung cancer. Journal Of Clinical Oncology 2024, 42: 3148-3148. DOI: 10.1200/jco.2024.42.16_suppl.3148.Peer-Reviewed Original ResearchNon-small cell lung cancerProgression-free survivalShorter progression-free survivalTyrosine kinase domainSystemic therapyCo-mutationsClinical characteristics of non-small cell lung cancerCharacteristics of non-small cell lung cancerFirst-line platinum-based chemotherapyMedian tumor mutation burdenNon-small cell lung cancer tumorsFirst-line systemic therapyTP53 co-mutationsPlatinum-based chemotherapyTumor mutational burdenKaplan-Meier methodCell lung cancerLog-rank testOptimal treatment strategyHistory of smokingCopy number profilesTumor profile dataJuxtamembrane domainSquamous histologyTrastuzumab deruxtecan
2023
EGFR tyrosine kinase inhibitors (TKIs) versus durvalumab (durva) following concurrent chemoradiation (CRT) in unresectable EGFR-mutant non-small-cell lung cancer (NSCLC).
Nassar A, Adib E, Feng J, Aredo J, Parikh K, Harris J, Velazquez Manana A, Ragavan M, Lin J, Piotrowska Z, Fitzgerald B, Grohé C, Sankar K, Neal J, Wakelee H, Shepherd F, Herbst R, Naqash A, Goldberg S, Kim S. EGFR tyrosine kinase inhibitors (TKIs) versus durvalumab (durva) following concurrent chemoradiation (CRT) in unresectable EGFR-mutant non-small-cell lung cancer (NSCLC). Journal Of Clinical Oncology 2023, 41: 8567-8567. DOI: 10.1200/jco.2023.41.16_suppl.8567.Peer-Reviewed Original ResearchEGFR tyrosine kinase inhibitorsDisease-free survivalTyrosine kinase inhibitorsTreatment-related adverse eventsConcurrent chemoradiationOverall survivalStage IIILonger disease-free survivalMulti-institutional retrospective analysisDefinitive radiation therapyPD-L1 expressionPD-L1 statusDefinitive concurrent chemoradiationEGFR-TKI therapyPlatinum-based chemotherapyCell lung cancerEGFR-mutant NSCLCGy of radiationAdjuvant osimertinibCTCAE 5.0PACIFIC trialAdvanced NSCLCConcurrent chemotherapyBaseline characteristicsMedian duration
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
2019
Blood tumor mutational burden (bTMB) and tumor PD-L1 as predictive biomarkers of survival in MYSTIC: First-line durvalumab (D) ± tremelimumab (T) versus chemotherapy (CT) in metastatic (m) NSCLC.
Rizvi N, Cho B, Reinmuth N, Lee K, Luft A, Ahn M, van den Heuvel M, Dols M, Vicente D, Smolin A, Moiseyenko V, Antonia S, Nakagawa K, Goldberg S, Kim E, Walker J, Raja R, Liu F, Scheuring U, Peters S. Blood tumor mutational burden (bTMB) and tumor PD-L1 as predictive biomarkers of survival in MYSTIC: First-line durvalumab (D) ± tremelimumab (T) versus chemotherapy (CT) in metastatic (m) NSCLC. Journal Of Clinical Oncology 2019, 37: 9016-9016. DOI: 10.1200/jco.2019.37.15_suppl.9016.Peer-Reviewed Original ResearchBlood tumor mutational burdenPredictive biomarkersPD-L1Tumor cell PD-L1 expressionPD-L1 IHC assaysAppropriate predictive biomarkersFirst-line durvalumabPD-L1 TCTumor PD-L1PD-L1 expressionPlatinum-based chemotherapyTumor mutational burdenExploratory analysisMetastatic NSCLCTreatment decisionsMutational burdenChemotherapyIHC assaysTC expressionBiomarkersSmall sample sizeExpression levelsFurther investigationOSAdditional cutoffs
2016
191TiP MYSTIC: a global, phase 3 study of durvalumab (MEDI4736) plus tremelimumab combination therapy or durvalumab monotherapy versus platinum-based chemotherapy (CT) in the first-line treatment of patients (pts) with advanced stage IV NSCLC
Peters S, Antonia S, Goldberg S, Heymach J, Kim E, Nakagawa K, Papadimitrakopoulou V, Mukhopadhyay P, McIntosh S, Rizvi N. 191TiP MYSTIC: a global, phase 3 study of durvalumab (MEDI4736) plus tremelimumab combination therapy or durvalumab monotherapy versus platinum-based chemotherapy (CT) in the first-line treatment of patients (pts) with advanced stage IV NSCLC. Journal Of Thoracic Oncology 2016, 11: s139-s140. DOI: 10.1016/s1556-0864(16)30300-8.Peer-Reviewed Original ResearchStage IV NSCLCFirst-line treatmentPhase 3 studyPlatinum-based chemotherapyDurvalumab monotherapyCombination therapyChemotherapy
2015
Phase III, randomized, open-label study of durvalumab (MEDI4736) in combination with tremelimumab or durvalumab alone versus platinum-based chemotherapy in first-line treatment of patients with advanced/metastatic NSCLC: MYSTIC
Rizvi N, Barlesi F, Brahmer J, Felip E, Forde P, Garassino M, Goldberg S, Vansteenkiste J, Jarkowski A, McIntosh S, Zhao L, Antonia S. Phase III, randomized, open-label study of durvalumab (MEDI4736) in combination with tremelimumab or durvalumab alone versus platinum-based chemotherapy in first-line treatment of patients with advanced/metastatic NSCLC: MYSTIC. Journal For ImmunoTherapy Of Cancer 2015, 3: p171. PMCID: PMC4646121, DOI: 10.1186/2051-1426-3-s2-p171.Peer-Reviewed Original ResearchOpen-label studyFirst-line treatmentPlatinum-based chemotherapyMetastatic NSCLCPhase IIIDurvalumabTremelimumabNSCLCChemotherapy