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Drug Evaluation

Ipilimumab in combination with nivolumab for the treatment of renal cell carcinoma

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Pages 947-957 | Received 11 May 2018, Accepted 15 Aug 2018, Published online: 30 Aug 2018

References

  • Znaor A, Lortet-Tieulent J, Laversanne M, et al. International variations and trends in renal cell carcinoma incidence and mortality. Eur Urol. 2015;67(3):519–530.
  • Wong MCS, Goggins WB, Yip BHK, et al. Incidence and mortality of kidney cancer: temporal patterns and global trends in 39 countries. Sci Rep. 2017;7(1):15698.
  • About Kidney Cancer. Atlanta, GA: american cancer society. [Cited 2018 Jul 31]: https://www.cancer.org/content/dam/CRC/PDF/Public/8659.00.pdf.
  • Siegel RL, Miller KD, Cancer statistics JA. (2017). CA Cancer J Clin. 2017;67(1):7–30.
  • Amato RJ. Chemotherapy for renal cell carcinoma. Semin Oncol. 2000;27(2):177–186.
  • Davis SD, Koizumi JH, Pitts WR. Spontaneous regression of pulmonary metastases from renal cell carcinoma. Urology. 1989;33(2):141–144.
  • Vogelzang NJ, Priest ER, Borden L. Spontaneous regression of histologically proved pulmonary metastases from renal cell carcinoma: a case with 5-year followup. J Urol. 1992;148(4):1247–1248.
  • Minasian LM, Motzer RJ, Gluck L, et al. Interferon alfa-2a in advanced renal cell carcinoma: treatment results and survival in 159 patients with long-term follow-up. J Clin Oncol. 1993;11(7):1368–1375.
  • Fyfe G, Fisher RI, Rosenberg SA, et al. Results of treatment of 255 patients with metastatic renal cell carcinoma who received high-dose recombinant interleukin-2 therapy. J Clin Oncol. 1995;13(3):688–696.
  • McDermott DF, Cheng SC, Signoretti S, et al. The high-dose aldesleukin “select” trial: a trial to prospectively validate predictive models of response to treatment in patients with metastatic renal cell carcinoma. Clin Cancer Res. 2015;21(3):561–568.
  • Passalacqua R, Buzio C, Buti S, et al. Phase III, randomised, multicentre trial of maintenance immunotherapy with low-dose interleukin-2 and interferon-alpha for metastatic renal cell cancer. Cancer Immunol Immunother. 2010;59(4):553–561.
  • Choueiri TK, Motzer RJ. Systemic therapy for metastatic renal-cell carcinoma. N Engl J Med. 2017;376(4):354–366.
  • FDA approves nivolumab plus ipilimumab combination for intermediate or poor-risk advanced renal cell carcinoma. Silver spring, MD: U.S. Food and drug administration, 2018. [Cited 2018 Apr 20]. Available from: https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm604685.htm.
  • Motzer RJ, Rini BI, McDermott DF, et al. Nivolumab for metastatic renal cell carcinoma: results of a randomized phase II trial. J Clin Oncol. 2015;33(13):1430–1437.
  • Motzer RJ, Tannir NM, McDermott DF, et al. Nivolumab plus ipilimumab versus sunitinib in advanced renal-cell carcinoma. N Engl J Med. 2018 Apr 5;378(14):1277–1290.
  • Motzer RJ, Hutson TE, Tomczak P, et al. Overall survival and updated results for sunitinib compared with interferon alfa in patients with metastatic renal cell carcinoma. J Clin Oncol. 2009;27(22):3584–3590.
  • Sternberg CN, Davis ID, Mardiak J, et al. Pazopanib in locally advanced or metastatic renal cell carcinoma: results of a randomized phase III trial. J Clin Oncol. 2010;28(6):1061–1068.
  • Motzer RJ, Hutson TE, Cella D, et al. Pazopanib versus sunitinib in metastatic renal-cell carcinoma. N Engl J Med. 2013;369(8):722–731.
  • Motzer RJ, Hutson TE, McCann L, et al. Overall survival in renal-cell carcinoma with pazopanib versus sunitinib. N Engl J Med. 2014;370(18):1769–1770.
  • Choueiri TK, Halabi S, Sanford BL, et al. Cabozantinib versus sunitinib as initial targeted therapy for patients with metastatic renal cell carcinoma of poor or intermediate risk: the alliance A031203 CABOSUN trial. J Clin Oncol. 2017;35(6):591–597.
  • Escudier B, Pluzanska A, Koralewski P, et al. Bevacizumab plus interferon alfa-2a for treatment of metastatic renal cell carcinoma: a randomised, double-blind phase III trial. Lancet. 2007;370(9605):2103–2111.
  • Rini BI, Halabi S, Rosenberg JE, et al. Bevacizumab plus interferon alfa compared with interferon alfa monotherapy in patients with metastatic renal cell carcinoma: CALGB 90206. J Clin Oncol. 2008;26(33):5422–5428.
  • Hudes G, Carducci M, Tomczak P, et al. Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. N Engl J Med. 2007;356(22):2271–2281.
  • Motzer RJ, Escudier B, McDermott DF, et al. Nivolumab versus everolimus in advanced renal-cell carcinoma. N Engl J Med. 2015;373(19):1803–1813.
  • Rini BI, Melichar B, Ueda T, et al. Axitinib with or without dose titration for first-line metastatic renal-cell carcinoma: a randomised double-blind phase 2 trial. Lancet Oncol. 2013;14(12):1233–1242.
  • Motzer RJ, Hutson TE, Glen H, et al. Lenvatinib, everolimus, and the combination in patients with metastatic renal cell carcinoma: a randomised, phase 2, open-label, multicentre trial. Lancet Oncol. 2015;16(15):1473–1482.
  • Motzer RJ, Escudier B, Oudard S, et al. Efficacy of everolimus in advanced renal cell carcinoma: a double-blind, randomised, placebo-controlled phase III trial. Lancet. 2008;372(9637):449–456.
  • Ko JJ, Xie W, Kroeger N, et al. The international metastatic renal cell carcinoma database consortium model as a prognostic tool in patients with metastatic renal cell carcinoma previously treated with first-line targeted therapy: a population-based study. Lancet Oncol. 2015;16(3):293–300.
  • Motzer RJ, Bacik J, Murphy BA, et al. Interferon-alfa as a comparative treatment for clinical trials of new therapies against advanced renal cell carcinoma. J Clin Oncol. 2002;20(1):289–296.
  • Cabometyx (cabozantinib): An overview of Cabometyx and why it is authorised in the EU. London: european medicines agency. [ Cited 2018 Jul 31]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/004163/WC500214073.pdf.
  • FDA grants regular approval to Cabometyx for first-line treatment of advanced renal cell carcinoma. Silver spring, MD: U.S. Food and drug administration. [ Cited 2018 Jul 31]. Available from: https://www.fda.gov/drugs/informationondrugs/approveddrugs/ucm589842.htm.
  • Miller LA, Stemkowski S, Saverno K, et al. Patterns of care in patients with metastatic renal cell carcinoma among a U.S. Payer population with commercial or medicare advantage membership. J Manag Care Spec Pharm. 2016;22(3):219–226.
  • Escudier B, Porta C, Bono P, et al. Randomized, controlled, double-blind, cross-over trial assessing treatment preference for pazopanib versus sunitinib in patients with metastatic renal cell carcinoma: PISCES study. J Clin Oncol. 2014;32(14):1412–1418.
  • Bi R, Nj V. Future challenges for drug development in renal cell carcinoma. J Clin Oncol. 2017;35(6):577–579.
  • Motzer RJ, Powles T, Atkins MB, et al. IMmotion151: A randomized phase III study of atezolizumab plus bevacizumab vs sunitinib in untreated metastatic renal cell carcinoma (mRCC). J Clin Oncol. 2018;36(suppl 6S):578.
  • Motzer RJ, Agarwal N, Beard C, et al. Kidney cancer. J Natl Compr Canc Netw. 2011;9(9):960–977.
  • Leach DR, Krummel MF, Allison JP. Enhancement of antitumor immunity by CTLA-4 blockade. Science. 1996;271(5256):1734–1736.
  • Hirano F, Kaneko K, Tamura H, et al. Blockade of B7-H1 and PD-1 by monoclonal antibodies potentiates cancer therapeutic immunity. Cancer Res. 2005;65(3):1089–1096.
  • Pardoll DM. The blockade of immune checkpoints in cancer immunotherapy. Nat Rev Cancer. 2012;12:252.
  • Sc W, Jh L, Ap C, et al. Distinct cellular mechanisms underlie Anti-CTLA-4 and Anti-PD-1 checkpoint blockade. Cell. 2017;170(6):1120–1133 e1117.
  • Ribas A, Wolchok JD. Cancer immunotherapy using checkpoint blockade. Science. 2018;359(6382):1350–1355.
  • Assessment report Nivolumab BMS. London: European Medicines Agency. [ Cited 2018 Mar 21]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/003840/WC500190651.pdf.
  • Opdivo (nivolumab) [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; 2016.).
  • Assessment Report For Yervoy (ipilimumab). London: european medicines agency. [Cited 2018 Mar 21]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002213/WC500109302.pdf.
  • Yervoy (ipilimumab) [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; 2015).
  • Tan S, Zhang H, Chai Y, et al. An unexpected N-terminal loop in PD-1 dominates binding by nivolumab. Nat Commun. 2017;8:14369.
  • Butte MJ, Keir ME, Phamduy TB, et al. Programmed death-1 ligand 1 interacts specifically with the B7–1 costimulatory molecule to inhibit T cell responses. Immunity. 2007;27(1):111–122.
  • Ishida Y, Agata Y, Shibahara K, et al. Induced expression of PD-1, a novel member of the immunoglobulin gene superfamily, upon programmed cell death. EMBO J. 1992;11(11):3887–3895.
  • Latchman Y, Wood CR, Chernova T, et al. PD-L2 is a second ligand for PD-1 and inhibits T cell activation. Nat Immunol. 2001;2(3):261–268.
  • Keir ME, Butte MJ, Freeman GJ, et al. and its ligands in tolerance and immunity. Annu Rev Immunol. 2008;26:677–704.
  • Sharpe AH, Pauken KE. The diverse functions of the PD1 inhibitory pathway. Nat Rev Immunol. 2018;18(3):153–167.
  • Brunet JF, Denizot F, Luciani MF, et al. A new member of the immunoglobulin superfamily–CTLA-4. Nature. 1987;328(6127):267–270.
  • Lindsten T, Lee KP, Harris ES, et al. Characterization of CTLA-4 structure and expression on human T cells. J Immunol. 1993;151(7):3489–3499.
  • Walunas TL, Lenschow DJ, Bakker CY, et al. CTLA-4 can function as a negative regulator of T cell activation. Immunity. 1994;1(5):405–413.
  • Krummel MF, Allison JP. CD28 and CTLA-4 have opposing effects on the response of T cells to stimulation. J Exp Med. 1995;182(2):459–465.
  • Ryman JT, Meibohm B. Pharmacokinetics of monoclonal antibodies. CPT Pharmacometrics Syst Pharmacol. 2017;6(9):576–588.
  • Hammers HJ, Plimack ER, Infante JR, et al. Safety and efficacy of nivolumab in combination with ipilimumab in metastatic renal cell carcinoma: the checkmate 016 study. J Clin Oncol. 2017;35(34):3851–3858.
  • Yang JC, Hughes M, Kammula U, et al. Ipilimumab (anti-CTLA4 antibody) causes regression of metastatic renal cell cancer associated with enteritis and hypophysitis. J Immunother. 2007;30(8):825–830.
  • Choueiri TK, Hessel C, Halabi S, et al. Cabozantinib versus sunitinib as initial therapy for metastatic renal cell carcinoma of intermediate or poor risk (Alliance A031203 CABOSUN randomised trial): progression-free survival by independent review and overall survival update. Eur J Cancer. 2018;94:115–125.
  • Larkin J, Chiarion-Sileni V, Gonzalez R, et al. Combined nivolumab and ipilimumab or monotherapy in untreated melanoma. N Engl J Med. 2015;373(1):23–34.
  • Wallis CJD, Klaassen Z, Bhindi B, et al. First-line systemic therapy for metastatic renal cell carcinoma: a systematic review and network meta-analysis. Eur Urol. 2018 Sep;74(3):309–321.
  • Rini BI, Dorff TB, Elson P, et al. Active surveillance in metastatic renal-cell carcinoma: a prospective, phase 2 trial. Lancet Oncol. 2016;17(9):1317–1324.
  • Atkins MB, Plimack ER, Puzanov I, et al. Axitinib in combination with pembrolizumab in patients with advanced renal cell cancer: a non-randomised, open-label, dose-finding, and dose-expansion phase 1b trial. Lancet Oncol. 2018;19(3):405–415.
  • Choueiri TK, Larkin J, Oya M, et al. Preliminary results for avelumab plus axitinib as first-line therapy in patients with advanced clear-cell renal-cell carcinoma (JAVELIN Renal 100): an open-label, dose-finding and dose-expansion, phase 1b trial. Lancet Oncol. 2018;19(4):451–460.
  • Lee C, Makker V, Rasco D, et al. A phase 1b/2 trial of lenvatinib plus pembrolizumab in patients with renal cell carcinoma. Ann Oncol. 2017;28(suppl_5):v295–v329.
  • Nadal RM, Mortazavi A, Stein M, et al. Results of phase I plus expansion cohorts of cabozantinib (Cabo) plus nivolumab (Nivo) and CaboNivo plus ipilimumab (Ipi) in patients (pts) with with metastatic urothelial carcinoma (mUC) and other genitourinary (GU) malignancies. J Clin Oncol. 2018;36(suppl 6S):abstr 515.
  • Wolchok JD, Chiarion-Sileni V, Gonzalez R, et al. Overall survival with combined nivolumab and ipilimumab in advanced melanoma. N Engl J Med. 2017;377(14):1345–1356.
  • McDermott DF, Lee J, Szczylik C, et al. Pembrolizumab monotherapy as first-line therapy in advanced clear cell renal cell carcinoma (accRCC): results from cohort A of KEYNOTE-427. J Clin Oncol. 2018;36(suppl):4500.
  • Izar B, Regan MM, McDermott DF. Clinical trial design and endpoints for stage IV melanoma in the modern era. Cancer J. 2017;23(1):63–67.
  • Botteman M, Shah R, Gupte-Singh K, et al. 1223PD – Quality-adjusted survival of combined nivolumab plus ipilimumab (NIVO+IPI) or NIVO alone vs IPI among treatment-naïve patients (pts) with advanced MEL enrolled in the checkMate 067 trial. Ann Oncol. 2017;28(suppl_5):v428–v448.
  • Anagnostou V, Yarchoan M, Ar H, et al. Immuno-oncology trial endpoints: capturing clinically meaningful activity. Clin Cancer Res. 2017;23(17):4959–4969.
  • McDermott DF, Regan MM, Clark JI, et al. Randomized phase III trial of high-dose interleukin-2 versus subcutaneous interleukin-2 and interferon in patients with metastatic renal cell carcinoma. J Clin Oncol. 2005;23(1):133–141.
  • Manson G, Norwood J, Marabelle A, et al. Biomarkers associated with checkpoint inhibitors. Ann Oncol. 2016;27(7):1199–1206.
  • McDermott DF, Huseni MA, Atkins MB, et al. Clinical activity and molecular correlates of response to atezolizumab alone or in combination with bevacizumab versus sunitinib in renal cell carcinoma. Nat Med. 2018;24(6):749–757.

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