Lenvatinib Therapy for the Treatment of Patients with Advanced Renal Cell Carcinoma

References

• Kidney cancer incidence statistics . Cancer Research UK. www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/kidney-cancer/incidence#heading-Six.
   Google Scholar
• Rini BI , CampbellSC, EscudierB. Renal cell carcinoma. Lancet373(9669), 1119–1132 (2009).
   PubMed Web of Science ®Google Scholar
• Eichelberg C , JunkerK, LjungbergB, MochH. Diagnostic and prognostic molecular markers for renal cell carcinoma: a critical appraisal of the current state of research and clinical applicability. Eur. Urol.55(4), 851–863 (2009).
   PubMed Web of Science ®Google Scholar
• Imai K , TakaokaA. Comparing antibody and small-molecule therapies for cancer. Nat. Rev. Cancer6(9), 714–727 (2006).
   PubMed Web of Science ®Google Scholar
• Mendel DB , LairdAD, XinXet al. In vivo antitumor activity of SU11248, a novel tyrosine kinase inhibitor targeting vascular endothelial growth factor and platelet-derived growth factor receptors: determination of a pharmacokinetic/pharmacodynamic relationship. Clin. Cancer Res.9(1), 327–337 (2003).
   PubMed Web of Science ®Google Scholar
• Faivre S , DemetriG, SargentW, RaymondE. Molecular basis for sunitinib efficacy and future clinical development. Nat. Rev. Drug Discov.6(9), 734–745 (2007).
   PubMed Web of Science ®Google Scholar
• Podar K , TononG, SattlerMet al. The small-molecule VEGF receptor inhibitor pazopanib (GW786034B) targets both tumor and endothelial cells in multiple myeloma. Proc. Natl Acad. Sci. USA103(51), 19478–19483 (2006).
   PubMed Web of Science ®Google Scholar
• Sloan B , ScheinfeldNS. Pazopanib, a VEGF receptor tyrosine kinase inhibitor for cancer therapy. Curr. Opin. Invest. Drugs9(12), 1324–1335 (2008).
   PubMed Web of Science ®Google Scholar
• Hu-Lowe DD , ZouHY, GrazziniMLet al. Nonclinical antiangiogenesis and antitumor activities of axitinib (AG-013736), an oral, potent, and selective inhibitor of vascular endothelial growth factor receptor tyrosine kinases 1, 2, 3. Clin. Cancer Res.14(22), 7272–7283 (2008).
   PubMed Web of Science ®Google Scholar
• Johnson LN . Protein kinase inhibitors: contributions from structure to clinical compounds. Q. Rev. Biophys.42(1), 1–40 (2009).
   PubMed Web of Science ®Google Scholar
• Wan PT , GarnettMJ, RoeSMet al. Mechanism of activation of the RAF–ERK signaling pathway by oncogenic mutations of B-RAF. Cell116(6), 855–867 (2004).
   PubMed Web of Science ®Google Scholar
• Guidelines on renal cell carcinoma . European Association of Urology (2014). http://uroweb.org/wp-content/uploads/10-Renal-Cell-Carcinoma_LR.pdf.
   Google Scholar
• Escudier B , EisenT, PortaCet al. Renal cell carcinoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann. Oncol.23(Suppl. 7), vii65–vii71 (2012).
   PubMed Web of Science ®Google Scholar
• Escudier B , PluzanskaA, KoralewskiPet al. Bevacizumab plus interferon alfa-2a for treatment of metastatic renal cell carcinoma: a randomised, double-blind Phase III trial. Lancet370(9605), 2103–2111 (2007).
   PubMed Web of Science ®Google Scholar
• Motzer RJ , HutsonTE, TomczakPet al. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N. Engl. J. Med.356(2), 115–124 (2007).
   PubMed Web of Science ®Google Scholar
• Sternberg CN , DavisID, MardiakJet al. Pazopanib in locally advanced or metastatic renal cell carcinoma: results of a randomized Phase III trial. J. Clin. Oncol.28(6), 1061–1068 (2010).
   PubMed Web of Science ®Google Scholar
• Hudes G , CarducciM, TomczakPet al. Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. N. Engl. J. Med.356(22), 2271–2281 (2007).
   PubMed Web of Science ®Google Scholar
• Rini BI , EscudierB, TomczakPet al. Comparative effectiveness of axitinib versus sorafenib in advanced renal cell carcinoma (AXIS): a randomised Phase 3 trial. Lancet378(9807), 1931–1939 (2011).
   PubMed Web of Science ®Google Scholar
• Motzer RJ , EscudierB, OudardSet al. Efficacy of everolimus in advanced renal cell carcinoma: a double-blind, randomized, placebo-controlled Phase III trial. Lancet372(9637), 449–456 (2008).
   PubMed Web of Science ®Google Scholar
• Motzer RJ , EscudierB, TomczakPet al. Axitinib versus sorafenib as second-line treatment for advanced renal cell carcinoma: overall survival analysis and updated results from a randomised Phase 3 trial. Lancet Oncol.14(6), 552–562 (2013).
   PubMed Web of Science ®Google Scholar
• Motzer RJ , EscudierB, McDermottDFet al. Nivolumab versus everolimus in advanced renal-cell carcinoma. N. Engl. J. Med.373(19), 1803–1813 (2015).
   PubMed Web of Science ®Google Scholar
• European commission approves Bristol-Myers Squibb’s Opdivo^® (nivolumab) for previously treated advanced renal cell carcinoma. Press releaseApril6, 2016. Bristol-Myers Squibb. http://investor.bms.com/investors/news-and-events/press-releases/press-release-details/2016/European-Commission-Approves-Bristol-Myers-Squibbs-Opdivo-nivolumab-for-Previously-Treated-Advanced-Renal-Cell-Carcinoma/default.aspx.
   Google Scholar
• Choueiri TK , EscudierB, PowlesTet al. Cabozantinib versus everolimus in advanced renal-cell carcinoma. N. Engl. J. Med.373(19), 1814–1823 (2015).
   PubMed Web of Science ®Google Scholar
• National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines^®). Kidney Cancer. Version 2.2016. www.nccn.org/professionals/physician_gls/PDF/kidney.pdf.
   Google Scholar
• Rini BI , AtkinsMB. Resistance to targeted therapy in renal-cell carcinoma. Lancet Oncol.10(10), 992–1000 (2009).
   PubMed Web of Science ®Google Scholar
• Gore ME , LarkinJM. Challenges and opportunities for converting renal cell carcinoma into a chronic disease with targeted therapies. Br. J. Cancer104(3), 399–406 (2011).
   PubMed Web of Science ®Google Scholar
• Bergers G , HanahanD. Modes of resistance to anti-angiogenic therapy. Nat. Rev. Cancer8(8), 592–603 (2008).
   PubMed Web of Science ®Google Scholar
• Sosman JA , PuzanovI, AtkinsMB. Opportunities and obstacles to combination targeted therapy in renal cell cancer. Clin. Cancer Res.13(2 Pt 2), S764–S769 (2007).
   PubMed Web of Science ®Google Scholar
• Okamoto K , KodamaK, TakaseKet al. Antitumor activities of the targeted multi-tyrosine kinase inhibitor lenvatinib (E7080) against RET gene fusion-driven tumor models. Cancer Lett.340(1), 97–103 (2013).
   PubMed Web of Science ®Google Scholar
• Yamamoto Y , MatsuiJ, MatsushimaTet al. Lenvatinib, an angiogenesis inhibitor targeting VEGFR/FGFR, shows broad antitumor activity in human tumor xenograft models associated with microvessel density and pericyte coverage. Vasc. Cell6, 18 (2014).
   PubMedGoogle Scholar
• Tohyama O , MatsuiJ, KodamaKet al. Antitumor activity of lenvatinib (e7080): an angiogenesis inhibitor that targets multiple receptor tyrosine kinases in preclinical human thyroid cancer models. J. Thyroid Res.2014, 638747 (2014).
   PubMedGoogle Scholar
• Lenvima (lenvatinib) [prescribing information] (2015). www.accessdata.fda.gov/drugsatfda_docs/label/2015/206947s000lbl.pdf.
   Google Scholar
• Lenvima (lenvatinib) [EPAR summary for the public]. EMA/218681/2015 (2015). www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/003727/WC500188677.pdf.
   Google Scholar
• Boss DS , GlenH, BeijnenJHet al. A Phase I study of E7080, a multitargeted tyrosine kinase inhibitor, in patients with advanced solid tumours. Br. J. Cancer106(10), 1598–1604 (2012).
   PubMed Web of Science ®Google Scholar
• Yamada K , YamamotoN, YamadaYet al. Phase I dose-escalation study and biomarker analysis of E7080 in patients with advanced solid tumors. Clin. Cancer Res.17(8), 2528–2537 (2011).
   PubMed Web of Science ®Google Scholar
• Motzer RJ , HutsonTE, GlenHet al. Lenvatinib, everolimus, and the combination in patients with metastatic renal cell carcinoma: a randomised, Phase 2, open-label, multicentre trial. Lancet Oncol.16(15), 1473–1482 (2015).
   PubMed Web of Science ®Google Scholar
• Gupta A , JarzabB, CapdevilaJ, ShumakerR, HusseinZ. Population pharmacokinetic analysis of lenvatinib in healthy subjects and patients with cancer. Br. J. Clin. Pharmacol.81(6), 1124–1133 (2016).
   PubMed Web of Science ®Google Scholar
• Molina AM , HutsonTE, LarkinJet al. A Phase 1b clinical trial of the multi-targeted tyrosine kinase inhibitor lenvatinib (E7080) in combination with everolimus for treatment of metastatic renal cell carcinoma (RCC). Cancer Chemother. Pharmacol.73(1), 181–189 (2014).
   PubMed Web of Science ®Google Scholar
• Motzer RJ , HutsonTE, RenM, DutcusC, LarkinJ. Independent assessment of lenvatinib plus everolimus in patients with metastatic renal cell carcinoma. Lancet Oncol.17(1), e4–e5 (2016).
   PubMed Web of Science ®Google Scholar
• Hutson T , DutcusCE, RenM, BaigM, FishmanM. Subgroup analyses and updated overall survival from the Phase 2 trial of lenvatinib (LEN), everolimus (EVE), and LEN+EVE in metastatic renal cell carcinoma (mRCC). Presented at: The Annual Meeting of the American Society of Clinical Oncology 2016. Chicargo, IL, USA, 3–7 June 2016 ( Abstract 4553).
   Google Scholar
• Motzer RJ , EscudierB, OudardSet al. Phase 3 trial of everolimus for metastatic renal cell carcinoma: final results and analysis of prognostic factors. Cancer116(18), 4256–4265 (2010).
   PubMed Web of Science ®Google Scholar
• Schlumberger M , TaharaM, WirthLJet al. Lenvatinib versus placebo in radioiodine-refractory thyroid cancer. N. Engl. J. Med.372(7), 621–630 (2015).
   PubMed Web of Science ®Google Scholar
• Glen H , HsiehJ, MichaelsonMDet al. Correlative analyses of serum biomarkers and clinical outcomes in the Phase 2 study of lenvatinib, everolimus, and the combination, in patients with metastatic renal cell carcinoma following 1 VEGF-targeted therapy [abstract]. Eur. J. Cancer51(Suppl. 3), Abstract 432 (2015).
   Google Scholar
• Bukowski RM , KabbinavarFF, FiglinRAet al. Randomized Phase II study of erlotinib combined with bevacizumab compared with bevacizumab alone in metastatic renal cell cancer. J. Clin. Oncol.25(29), 4536–4541 (2007).
   PubMed Web of Science ®Google Scholar
• Négrier S , GravisG, PérolDet al. Temsirolimus and bevacizumab, or sunitinib, or interferon alfa and bevacizumab for patients with advanced renal cell carcinoma (TORAVA): a randomised Phase 2 trial. Lancet Oncol.12(7), 673–680 (2011).
   PubMed Web of Science ®Google Scholar
• Flaherty KT , ManolaJB, PinsMet al. BEST: A randomized Phase II study of vascular endothelial growth factor, RAF kinase, and mammalian target of rapamycin combination targeted therapy with bevacizumab, sorafenib, and temsirolimus in advanced renal cell carcinoma – a trial of the ECOG-ACRIN Cancer Research Group (E2804). J. Clin. Oncol.33(21), 2384–2391 (2015).
   PubMed Web of Science ®Google Scholar
• Rini BI , BellmuntJ, ClancyJet al. Randomized Phase III trial of temsirolimus and bevacizumab versus interferon alfa and bevacizumab in metastatic renal cell carcinoma: INTORACT trial. J. Clin. Oncol.32(8), 752–759 (2014).
   PubMed Web of Science ®Google Scholar
• Ravaud A , BarriosCH, AlekseevBet al. RECORD-2: Phase II randomized study of everolimus and bevacizumab versus interferon alpha-2a and bevacizumab as first-line therapy in patients with metastatic renal cell carcinoma. Ann. Oncol.26(7), 1378–1384 (2015).
   PubMed Web of Science ®Google Scholar
• Welti JC , GourlaouenM, PowlesTet al. Fibroblast growth factor 2 regulates endothelial cell sensitivity to sunitinib. Oncogene30(10), 1183–1193 (2011).
   PubMed Web of Science ®Google Scholar
• Tsimafeyeu I , DemidovL, StepanovaE, WynnN, TaH. Overexpression of fibroblast growth factor receptors FGFR1 and FGFR2 in renal cell carcinoma. Scand. J. Urol. Nephrol.45(3), 190–195 (2011).
   PubMed Web of Science ®Google Scholar
• Wang X , BullockAJ, ZhangLet al. The role of angiopoietins as potential therapeutic targets in renal cell carcinoma. Transl. Oncol.7(2), 188–195 (2014).
   PubMed Web of Science ®Google Scholar
• Casanovas O , HicklinDJ, BergersG, HanahanD. Drug resistance by evasion of antiangiogenic targeting of VEGF signaling in late-stage pancreatic islet tumors. Cancer Cell8(4), 299–309 (2005).
   PubMed Web of Science ®Google Scholar
• Angevin E , Lopez-MartinJA, LinCCet al. Phase I study of dovitinib (TKI258), an oral FGFR, VEGFR, and PDGFR inhibitor, in advanced or metastatic renal cell carcinoma. Clin. Cancer Res.19(5), 1257–1268 (2013).
   PubMed Web of Science ®Google Scholar
• Kim KB , ChesneyJ, RobinsonD, GardnerH, ShiMM, KirkwoodJM. Phase I/II and pharmacodynamic study of dovitinib (TKI258), an inhibitor of fibroblast growth factor receptors and VEGF receptors, in patients with advanced melanoma. Clin. Cancer Res.17(23), 7451–7461 (2011).
   PubMed Web of Science ®Google Scholar
• Eisai launches in-house developed novel anticancer agent Lenvima^® (lenvatinib mesylate) as treatment for unresectable thyroid cancer in Japan. News release. May20, 2015. Eisai Co., Ltd. www.eisai.com/news/news201532.html.
   Google Scholar
• EIsai submits new application in europe for in-house developed anticancer agent lenvatinib seeking approval for indication covering renal cell carcinoma. www.eisai.com/news/news201602.html.
   Google Scholar