Brigatinib for ALK-positive metastatic non-small-cell lung cancer: design, development and place in therapy

References

• SEERCancer stat facts: lung and bronchus cancerBethesda, MDNational Cancer Institute Available from: https://seer.cancer.gov/statfacts/html/lungb.htmlAccessed January 21, 2019
   Google Scholar
• SchillerJHHarringtonDBelaniCPComparison of four chemotherapy regimens for advanced non-small-cell lung cancerN Engl J Med Overseas Ed200234629298
   PubMed Web of Science ®Google Scholar
• SodaMChoiYLEnomotoMIdentification of the transforming EML4-ALK fusion gene in non-small-cell lung cancerNature2007448715356156617625570
   PubMed Web of Science ®Google Scholar
• CamidgeDRBangYJKwakELActivity and safety of crizotinib in patients with ALK-positive non-small-cell lung cancer: updated results from a phase 1 studyLancet Oncol201213101011101922954507
   PubMed Web of Science ®Google Scholar
• ShawATYeapBYMino-KenudsonMClinical features and outcome of patients with non-small-cell lung cancer Who Harbor EML4-ALKJ Clin Oncol200927264247425319667264
   PubMed Web of Science ®Google Scholar
• ShawATSolomonBTargeting anaplastic lymphoma kinase in lung cancerClin Cancer Res20111782081208621288922
   PubMed Web of Science ®Google Scholar
• DoebeleRCLuXSumeyCOncogene status predicts patterns of metastatic spread in treatment-naive nonsmall cell lung cancerCancer2012118184502451122282022
   PubMed Web of Science ®Google Scholar
• KangHJLimHJParkJSComparison of clinical characteristics between patients with ALK-positive and EGFR-positive lung adenocarcinomaRespir Med2014108238839424361161
   PubMed Web of Science ®Google Scholar
• SolomonBJMokTKimDWFirst-line crizotinib versus chemotherapy in ALK-positive lung cancerN Engl J Med2014371232167217725470694
   PubMed Web of Science ®Google Scholar
• KatayamaRLovlyCMShawATTherapeutic targeting of anaplastic lymphoma kinase in lung cancer: a paradigm for precision cancer medicineClin Cancer Res201521102227223525979929
   PubMed Web of Science ®Google Scholar
• ToyokawaGSetoTUpdated evidence on the mechanisms of resistance to ALK inhibitors and strategies to overcome such resistance: clinical and preclinical dataOncol Res Treat201538629129826045026
   PubMed Web of Science ®Google Scholar
• CostaDBShawATOuSHClinical experience with crizotinib in patients with advanced ALK-rearranged non-small-cell lung cancer and brain metastasesJ Clin Oncol201533171881188825624436
   PubMed Web of Science ®Google Scholar
• CostaDBKobayashiSPandyaSSCSF concentration of the anaplastic lymphoma kinase inhibitor crizotinibJ Clin Oncol20112915e443e44521422405
   PubMed Web of Science ®Google Scholar
• TangSCNguyenLNSparidansRWWagenaarEBeijnenJHSchinkelAHIncreased oral availability and brain accumulation of the ALK inhibitor crizotinib by coadministration of the p-glycoprotein (ABCB1) and breast cancer resistance protein (ABCG2) inhibitor elacridarInt J Cancer201413461484149424037730
   PubMed Web of Science ®Google Scholar
• ShawATKimDWMehraRCeritinib in ALK-rearranged non-small-cell lung cancerN Engl J Med2014370131189119724670165
   PubMed Web of Science ®Google Scholar
• ShawATGandhiLGadgeelSStudy investigatorsAlectinib in ALK-positive, crizotinib-resistant, non-small-cell lung cancer: a single-group, multicentre, phase 2 trialLancet Oncol201617223424226708155
   PubMed Web of Science ®Google Scholar
• KimDWTiseoMAhnMJBrigatinib in patients with crizotinib-refractory anaplastic lymphoma kinase-positive non-small-cell lung cancer: a randomized, multicenter phase II trialJ Clin Oncol201735222490249828475456
   PubMed Web of Science ®Google Scholar
• HidaTNokiharaHKondoMAlectinib versus crizotinib in patients with ALK-positive non-small-cell lung cancer (J-ALEX): an open-label, randomised phase 3 trialLancet201739010089293928501140
   PubMed Web of Science ®Google Scholar
• PeronaRCell signalling: growth factors and tyrosine kinase receptorsClin Transl Oncol200682778216632420
   PubMedGoogle Scholar
• SégalinyAITellez-GabrielMHeymannMFHeymannDReceptor tyrosine kinases: characterisation, mechanism of action and therapeutic interests for bone cancersJ Bone Oncol20154111226579483
   PubMed Web of Science ®Google Scholar
• SchlessingerJReceptor tyrosine kinases: legacy of the first two decadesCold Spring Harb Perspect Biol201463a00891224591517
   PubMed Web of Science ®Google Scholar
• HoneggerAMSzaparyDSchmidtAA mutant epidermal growth factor receptor with defective protein tyrosine kinase is unable to stimulate proto-oncogene expression and DNA synthesisMol Cell Biol1987712456845713501826
   PubMed Web of Science ®Google Scholar
• GschwindAFischerOMUllrichAThe discovery of receptor tyrosine kinases: targets for cancer therapyNat Rev Cancer20044536137015122207
   PubMed Web of Science ®Google Scholar
• CamidgeDRBangYJKwakELProgression-free survival (PFS) from a phase I study of crizotinib (PF-02341066) in patients with ALK-positive non-small cell lung cancer (NSCLC)J Clin Oncol201129suppl abstr 2501
   Google Scholar
• KatayamaRKhanTMBenesCTherapeutic strategies to overcome crizotinib resistance in non-small cell lung cancers harboring the fusion oncogene EML4-ALKProc Natl Acad Sci U S A2011108187535754021502504
   PubMed Web of Science ®Google Scholar
• KinoshitaKAsohKFuruichiNDesign and synthesis of a highly selective, orally active and potent anaplastic lymphoma kinase inhibitor (CH5424802)Bioorg Med Chem20122031271128022225917
   PubMed Web of Science ®Google Scholar
• HuangWSLiuSZouDDiscovery of Brigatinib (AP26113), a phosphine oxide-containing, potent, orally active inhibitor of anaplastic lymphoma kinaseJ Med Chem201659104948496427144831
   PubMed Web of Science ®Google Scholar
• Ignatius OuSHAzadaMHsiangDJNext-generation sequencing reveals a novel NSCLC ALK F1174V mutation and confirms ALK G1202R mutation confers high-level resistance to alectinib (CH5424802/RO5424802) in ALK-rearranged NSCLC patients who progressed on crizotinibJ Thorac Oncol20149454955324736079
   PubMed Web of Science ®Google Scholar
• KatayamaRFribouletLKoikeSTwo novel ALK mutations mediate acquired resistance to the next-generation ALK inhibitor alectinibClin Cancer Res201420225686569625228534
   PubMed Web of Science ®Google Scholar
• SabariJKSantiniFCSchramAMThe activity, safety, and evolving role of brigatinib in patients with ALK-rearranged non-small cell lung cancersOnco Targets Ther2017101983199228435288
   PubMed Web of Science ®Google Scholar
• WeickhardtAJScheierBBurkeJMLocal ablative therapy of oligoprogressive disease prolongs disease control by tyrosine kinase inhibitors in oncogene-addicted non-small-cell lung cancerJ Thorac Oncol20127121807181423154552
   PubMed Web of Science ®Google Scholar
• FribouletLLiNKatayamaRThe ALK inhibitor ceritinib overcomes crizotinib resistance in non-small cell lung cancerCancer Discov20144666267324675041
   PubMed Web of Science ®Google Scholar
• SakamotoHTsukaguchiTHiroshimaSCH5424802, a selective ALK inhibitor capable of blocking the resistant gatekeeper mutantCancer Cell201119567969021575866
   PubMed Web of Science ®Google Scholar
• GadgeelSMGandhiLRielyGJSafety and activity of alectinib against systemic disease and brain metastases in patients with crizotinib-resistant ALK-rearranged non-small-cell lung cancer (AF-002JG): results from the dose-finding portion of a phase 1/2 studyLancet Oncol201415101119112825153538
   PubMed Web of Science ®Google Scholar
• OuSHAhnJSDe PetrisLAlectinib in crizotinib-refractory ALK-rearranged non-small-cell lung cancer: a phase II global studyJ Clin Oncol201634766166826598747
   PubMed Web of Science ®Google Scholar
• OuSHGreenboweJKhanZUI1171 missense mutation (particularly I1171N) is a common resistance mutation in ALK-positive NSCLC patients who have progressive disease while on alectinib and is sensitive to ceritinibLung Cancer201588223123425736571
   PubMed Web of Science ®Google Scholar
• ZhangSAnjumRSquillaceRThe potent ALK inhibitor Brigatinib (AP26113) overcomes mechanisms of resistance to first- and second-generation ALK inhibitors in preclinical modelsClin Cancer Res201622225527553827780853
   PubMed Web of Science ®Google Scholar
• CamidgeDRKimDWTiseoMExploratory analysis of Brigatinib activity in patients with anaplastic lymphoma kinase-positive non-small-cell lung cancer and brain metastases in two clinical trialsJ Clin Oncol201836262693270129768119
   PubMed Web of Science ®Google Scholar
• GettingerSNBazhenovaLALangerCJActivity and safety of brigatinib in ALK-rearranged non-small-cell lung cancer and other malignancies: a single-arm, open-label, phase 1/2 trialLancet Oncol201617121683169627836716
   PubMed Web of Science ®Google Scholar
• PetersSCamidgeDRShawATALEX Trial InvestigatorsAlectinib versus crizotinib in untreated ALK-positive non-small-cell lung cancerN Engl J Med2017377982983828586279
   PubMed Web of Science ®Google Scholar
• GadgeelSMShawATGovindanRALEX Trial InvestigatorsPooled analysis of CNS response to alectinib in two studies of pretreated patients with ALK-positive non-small-cell lung cancerJ Clin Oncol201634344079408527863201
   PubMed Web of Science ®Google Scholar
• ZouHYFribouletLKodackDPPF-06463922, an ALK/ROS1 inhibitor, overcomes resistance to first and second generation ALK inhibitors in preclinical modelsCancer Cell2015281708126144315
   PubMed Web of Science ®Google Scholar
• CollierTLNormandinMDStephensonNASynthesis and preliminary PET imaging of 11C and 18F isotopologues of the ROS1/ALK inhibitor lorlatinibNat Commun201781576128594000
   PubMed Web of Science ®Google Scholar
• ShawATFelipEBauerTMLorlatinib in non-small-cell lung cancer with ALK or ROS1 rearrangement: an international, multicentre, open-label, single-arm first-in-man phase 1 trialLancet Oncol201718121590159929074098
   PubMed Web of Science ®Google Scholar
• SolomonBShawAOuSOA 05.06 phase 2 study of lorlatinib in patients with advanced ALK+/ROS1+ non-small-cell lung cancerJ Thorac Oncol20171211S1756
   Web of Science ®Google Scholar
• ShawATFribouletLLeshchinerIResensitization to Crizotinib by the Lorlatinib ALK Resistance Mutation L1198FN Engl J Med20163741546126698910
   PubMed Web of Science ®Google Scholar
• LiuDOffinMHarnicarSLiBTDrilonAEntrectinib: an orally available, selective tyrosine kinase inhibitor for the treatment of NTRK, ROS1, and ALK fusion-positive solid tumorsTher Clin Risk Manag2018141247125230050303
   PubMed Web of Science ®Google Scholar
• AhnMJChoBCSienaSEntrectinib in patients with locally advanced or metastatic ROS1 fusion-positive non-small cell lung cancer (NSCLC)Presented at: IASLC 18th World Conference on Lung Cancer20171518Yokohama, Japan Abstract 8564
   Google Scholar
• De Lima LopesGWuYLSadowskiSP2.43: pembrolizumab vs platinum-based chemotherapy for PD-L1+ NSCLC: phase 3, randomized, open-label KEYNOTE-042 (NCT02220894): track: immunotherapyJ Thorac Oncol20161110SS244S24527676577
   PubMedGoogle Scholar
• SocinskiMAJotteRMCappuzzoFAtezolizumab for first-line treatment of metastatic Nonsquamous NSCLCN Engl J Med2018378242288230129863955
   PubMed Web of Science ®Google Scholar
• CrinoLKDKimDRileyGJInitial phase II results with crizotinib in advanced ALK-positive non-small cell lung cancer (NSCLC): PROFILE 1005J Clin Oncol201129suppl abstr 7514
   PubMed Web of Science ®Google Scholar
• AhnMCamidgeDRTiseoMBrigatinib in crizotinib refractory ALK+ NSCLC: updated efficacy and safety results from ALTA, a randomized phase 2 trialJ Thorac Oncol20171211S2S17551756
   Web of Science ®Google Scholar
• European Commission Approves ALUNBRIG® (brigatinib) for ALK+ Non-Small Cell Lung Cancer in Patients Previously Treated with Crizotinib, Advancing Treatment Paradigm in Europe. November 27, 2018.
   Google Scholar