Antibodies to watch in 2019

mAbs

Volumn 11, Issue 2, 2019, Pages 219-238

  Kaplon, Hélène ^a   Reichert, Janice M ^b  

^a INSTITUT DE RECHERCHES INTERNATIONALES SERVIER   (France)

^b Antibody Society   (United States)

Author keywords

antibody therapeutics; cancer; European Medicines Agency; Food and Drug Administration; immune mediated disorders; success rates

Indexed keywords

BROLUCIZUMAB; BUROSUMAB; CAMRELIZUMAB; CAPLACIZUMAB; CEMIPLIMAB; CRIZANLIZUMAB; EMAPALUMAB; ENFORTUMAB VEDOTIN; EPTINEZUMAB; ERENUMAB; FREMANEZUMAB; GALCANEZUMAB; GUSELKUMAB; IBALIZUMAB; IBI308; ISATUXIMAB; LANADELUMAB; LERONLIMAB; MOGAMULIZUMAB; MOXETUMOMAB PASUDOTOX; OPORTUZUMAB MONATOX; POLATUZUMAB VEDOTIN; RAVULIZUMAB; RISANKIZUMAB; ROMOSOZUMAB; SACITUZUMAB GOVITECAN; SATRALIZUMAB; SHR1210; SPARTALIZUMAB; TANEZUMAB; TILDRAKIZUMAB; TISLELIZUMAB; UNINDEXED DRUG;

ANGIONEUROTIC EDEMA; ANTIRETROVIRAL THERAPY; ARTICLE; BLADDER CANCER; BONE METASTASIS; BREAST CANCER; CANCER PAIN; CANCER THERAPY; CHRONIC LYMPHATIC LEUKEMIA; COLORECTAL CANCER; DIFFUSE LARGE B CELL LYMPHOMA; DIZZINESS; DRUG SAFETY; ENDOMETRIUM CANCER; EPISODIC MIGRAINE; ESOPHAGEAL SQUAMOUS CELL CARCINOMA; ESOPHAGUS CARCINOMA; FAMILIAL HYPERCHOLESTEROLEMIA; GLIOBLASTOMA; HAIRY CELL LEUKEMIA; HEAD AND NECK CANCER; HEMOLYTIC UREMIC SYNDROME; HEMOPHAGOCYTIC SYNDROME; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; HYPERCHOLESTEROLEMIA; HYPERTHYROIDISM; HYPOPHOSPHATEMIA; IMMUNOSUPPRESSIVE TREATMENT; IMMUNOTHERAPY; JUVENILE RHEUMATOID ARTHRITIS; LIVER CELL CARCINOMA; METASTATIC MELANOMA; MIGRAINE; MULTIPLE SCLEROSIS; NEUROENDOCRINE TUMOR; OSTEOPOROSIS; OVERALL SURVIVAL; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PLATELET COUNT; PROGRESSION FREE SURVIVAL; PROSTATE CANCER; RANDOMIZED CONTROLLED TRIAL (TOPIC); RHEUMATOID ARTHRITIS; SPONDYLARTHRITIS; T CELL LYMPHOMA; TUMOR MICROENVIRONMENT; ULCERATIVE COLITIS; VIRUS LOAD;

EID: 85058999976     PISSN: 19420862     EISSN: 19420870     Source Type: Journal    
DOI: 10.1080/19420862.2018.1556465     Document Type: Article

References (93)

1. The Royal Swedish Academy of Sciences. Scientific background on the Nobel Prize in Chemistry 2018: directed evolution of enzymes and binding proteins. https://www.nobelprize.org/uploads/2018/10/advanced-chemistryprize-2018.pdf
2. Smith GP., Filamentous fusion phage: novel expression vectors that display cloned antigens on the virion surface. Science. 1985;228(4705):1315–1317. doi:10.1126/science.4001944
3. Scott JK, Smith GP. Searching for peptide ligands with an epitope library. Science. 1990;249(4967):386–390
4. Frenzel A, Schirrmann T, Hust M. Phage display-derived human antibodies in clinical development and therapy. MAbs. 2016;8(7):1177–1194. doi:10.1080/19420862.2016.1212149
5. Nixon AE, Sexton DJ, Ladner RC. Drugs derived from phage display: from candidate identification to clinical practice. MAbs. 2014;6(1):73–85. doi:10.4161/mabs.27240
6. The Royal Swedish Academy of Sciences. The Nobel Prize in Physiology or Medicine 2018. NobelPrize.org. Nobel Media AB 2018. Fri. [accessed 2018 Oct 26]. https://www.nobelprize.org/prizes/medicine/2018/summary/
7. Ishida Y, Agata Y, Shibahara K, Honjo T. Induced expression of PD-1, a novel member of the immunoglobulin gene superfamily, upon programmed cell death. Embo J. 1992;11(11):3887–3895
8. Leach DR, Krummel MF, Allison JP. Enhancement of antitumor immunity by CTLA-4 blockade. Science. 1996;271(5256):1734–1736
9. Donini C, D’Ambrosio L, Grignani G, Aglietta M, Sangiolo D. Next generation immune-checkpoints for cancer therapy. J Thorac Dis. 2018;10(Suppl 13):S1581–S1601. doi:10.21037/jtd.2018.02.79
10. Reichert JM, Rosensweig CJ, Faden LB, Dewitz MC. Monoclonal antibody successes in the clinic. Nat Biotechnol. 2005;23(9):1073–1078. doi:10.1038/nbt0905-1073
11. Hay M, Thomas DW, Craighead JL, Economides C, Rosenthal J. Clinical development success rates for investigational drugs. Nat Biotechnol. 2014;32(1):40–51. doi:10.1038/nbt.2786
12. Kaplon H, Reichert JM. Antibodies to watch in 2018. MAbs. 2018;10(2):183–203. doi:10.1080/19420862.2018.1415671
13. Reichert JM. Antibodies to watch in 2017. MAbs. 2017;9(2):167–181. doi:10.1080/19420862.2016.1269580
14. Reichert JM. Antibodies to watch in 2016. MAbs. 2016;8(2):197–204. doi:10.1080/19420862.2015.1125583
15. Reichert JM. Antibodies to watch in 2015. MAbs. 2015;7(1):1–8. doi:10.4161/19420862.2015.988944
16. Reichert JM. Antibodies to watch in 2014. MAbs. 2014;6(1):5–14. doi:10.4161/mabs.27333
17. Reichert JM. Which are the antibodies to watch in 2013? MAbs. 2013;5(1):1–4. doi:10.4161/mabs.22976
18. Reichert JM. Which are the antibodies to watch in 2012? MAbs. 2012;4(1):1–3. doi:10.4161/mabs.4.1.18719
19. Reichert JM. Antibody-based therapeutics to watch in 2011. MAbs. 2011;3(1):76–99
20. Reichert JM. Antibodies to watch in 2010. MAbs. 2010;2(1):84–100
21. US Food and Drug Administration. FDA approves novel preventive treatment for migraine. May 17, 2018 press release. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm608120.htm?utm_campaign=05172018_PR_FDA%20approves%20migraine%20prevention%20treatment&utm_medium=email&utm_source=Eloqua
22. Teva Pharmaceutical Industries Ltd. Teva announces U.S. approval of AJOVY™ (fremanezumab-vfrm) injection, the first and only anti-CGRP treatment with both quarterly and monthly dosing for the preventive treatment of migraine in adults. September 14, 2018 press release. http://ir.tevapharm.com/phoenix.zhtml?c=73925&p=irol-newsArticle&ID=2367592
23. Dodick DW, Silberstein SD, Bigal ME, Yeung PP, Goadsby PJ, Blankenbiller T, Grozinski-Wolff M, Yang R, Ma Y, Aycardi E. Effect of fremanezumab compared with placebo for prevention of episodic migraine: a randomized clinical trial. JAMA. 2018;319(19):1999–2008. doi:10.1001/jama.2018.4853
24. Lilly E, and Company. Lilly’s Emgality™ (galcanezumab-gnlm) receives U.S. FDA approval for the preventive treatment of migraine in adults. September 27, 2018 press release. https://investor.lilly.com/news-releases/news-release-details/lillys-emgalitytm-galcanezumab-gnlm-receives-us-fda-approval
25. Kyowa Hakko Kirin Co. Ltd, Kyowa Kirin International PLC, Ultragenyx Pharmaceutical Inc. Kyowa Kirin and Ultragenyx Announce Crysvita® (burosumab) receives conditional marketing authorisation in Europe for the treatment of X–linked hypophosphatemia in children. February 23, 2018 press release. www.kyowa-kirin.com/news_releases/2018/pdf/e20180223_01.pdf
26. Insogna KL, Briot K, Imel EA, Kamenický P, Ruppe MD, Portale AA, Weber T, Pitukcheewanont P, Cheong HI, Jan de Beur S, et al., AXLES 1 Investigators. A randomized, double-blind, placebo-controlled, phase 3 trial evaluating the efficacy of burosumab, an anti-FGF23 antibody, in adults with X-linked hypophosphatemia: week 24 primary analysis. J Bone Miner Res. 2018 Aug;33(8):1383–1393. doi:10.1002/jbmr.3475
27. US Food and Drug Administration. FDA approves first therapy for rare inherited form of rickets, x-linked hypophosphatemia. April 17, 2018 press release. https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm604810.htm
28. Shire plc. Shire announces FDA approval of TAKHZYRO™ (lanadelumab-flyo), a first-of-its-kind mAb preventive treatment for hereditary angioedema. August 23, 2018 press release. https://www.shire.com/en/newsroom/2018/august/4fhgmy
29. Sanofi. Cablivi™ (caplacizumab) approved in Europe for adults with acquired thrombotic thrombocytopenic purpura (aTTP). September 3, 2018 press release. http://www.news.sanofi.us/2018-09-03-Cablivi-TM-caplacizumab-approved-in-Europe-for-adults-with-acquired-thrombotic-thrombocytopenic-purpura-aTTP
30. Scully M, Cataland S, Peyvandi F, Coppo P, Knoebl P, Kremer Hovinga JA, Metjian A, de la Rubia J, Pavenski K, Callewaert F, et al. Results of the randomized, double-blind, placebo-controlled, phase 3 Hercules study of caplacizumab in patients with acquired thrombotic thrombocytopenic purpura. 59th Annual Meeting of the American Society of Hematology; 2017 Dec 12, Atlanta, GA. https://www.ablynx.com/uploads/events/ca854140-58c3-4357-9695-4b81c1996c75-12dec2017_caplacizumabherculesash_final.pdf
31. US Food and Drug Administration. FDA approves treatment for two rare types of non-Hodgkin lymphoma. August 8, 2018 press release. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm616176.htm
32. Beck A, Reichert JM. Marketing approval of mogamulizumab: a triumph for glyco-engineering. MAbs. 2012;4(4):419–425. doi:10.4161/mabs.20996
33. Pastan I, Onda M, Weldon J, Fitzgerald D, Kreitman R. Immunotoxins with decreased immunogenicity and improved activity. Leuk Lymphoma. 2011;52(Suppl 2):87–90. doi:10.3109/10428194.2011.573039
34. Kreitman RJ, Dearden C, Zinzani PL, Delgado J, Karlin L, Robak T, Gladstone DE, le Coutre P, Dietrich S, Gotic M, et al. Moxetumomab pasudotox in relapsed/refractory hairy cell leukemia. Leukemia. 2018;32(8):1768–1777. doi:10.1038/s41375-018-0210-1
35. Regeneron Pharmaceuticals, Inc. FDA approves Libtayo® (cemiplimab-rwlc) as first and only treatment for advanced cutaneous squamous cell carcinoma. September 28, 2018 press release. https://investor.regeneron.com/news-releases/news-release-details/fda-approves-libtayor-cemiplimab-rwlc-first-and-only-treatment
36. US Food and Drug Administration. FDA approves new HIV treatment for patients who have limited treatment options. March 6, 2018 press release. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm599657.htm
37. Emu B, Fessel J, Schrader S, Kumar P, Richmond G, Win S, Weinheimer S, Marsolais C, Lewis S. Phase 3 study of ibalizumab for multidrug-resistant HIV-1. N Engl J Med. 2018;379(7):645–654. doi:10.1056/NEJMoa1711460
38. US Food and Drug Administration. TROGARZO™ (ibalizumab-uiyk) prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761065lbl.pdf
39. Reich K, Papp KA, Blauvelt A, Tyring SK, Sinclair R, Thaçi D, Nograles K, Mehta A, Cichanowitz N, Li Q, et al. Tildrakizumab versus placebo or etanercept for chronic plaque psoriasis (reSURFACE 1 and reSURFACE 2): results from two randomised controlled, phase 3 trials. Lancet. 2017 Jul 15;390(10091):276–288. doi:10.1016/S0140-6736(17)31279-5
40. Blauvelt A, Reich K, Papp KA, Kimball AB, Gooderham M, Tyring SK, Sinclair R, Thaçi D, Li Q, Cichanowitz N, et al. Safety of tildrakizumab for moderate-to-severe plaque psoriasis: pooled analysis of three randomized controlled trials. Br J Dermatol. 2018;179(3):615–622. doi:10.1111/bjd.16724
41. US Food and Drug Administration. FDA approves first treatment specifically for patients with rare and life-threatening type of immune disease. November 20, 2018 press release. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm626263.htm
42. Immunomedics. Corporate overview. September 2018. https://www.immunomedics.com/wp-content/uploads/2018/09/Corporate-Presentation-September-2018.pdf
43. Alexion Pharmaceuticals. FDA accepts priority review of ALXN1210 as a treatment for patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) in the US. August 20, 2018 press release. http://ir.alexion.com/news-releases/news-release-details/fda-accepts-priority-review-alxn1210-treatment-patients
44. Alexion Pharmaceuticals. Alexion announces positive top-line results showing successful phase 3 clinical study of ALXN1210 in complement inhibitor treatment-naïve patients with Paroxysmal Nocturnal Hemoglobinuria (PNH). March 15, 2018 press release. https://news.alexion.com/press-release/product-news/alexion-announces-positive-top-line-results-showing-successful-phase-3-cl
45. AbbVie. AbbVie submits biologics license application to U.S. FDA for investigational treatment risankizumab for moderate to severe plaque psoriasis. April 25, 2018 press release. https://news.abbvie.com/news/abbvie-submits-biologics-license-application-to-us-fda-for-investigational-treatment-risankizumab-for-moderate-to-severe-plaque-psoriasis.htm
46. Gordon KB, Strober B, Lebwohl M, Augustin M, Blauvelt A, Poulin Y, Papp KA, Sofen H, Puig L, Foley P, et al. Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled phase 3 trials. Lancet. 2018;392(10148):650–661. doi:10.1016/S0140-6736(18)31713-6
47. Amgen and UCB. Amgen and UCB provide update on regulatory status of EVENITY™ (romosozumab) in the US. July 16, 2017. https://www.amgen.com/media/news-releases/2017/07/amgen-and-ucb-provide-update-on-regulatory-status-of-evenity-romosozumab-in-the-us/
48. Amgen and UCB. Amgen and UCB resubmit biologics license application (BLA) for EVENITY™ (romosozumab) to the US FDA. July 12, 2018 press release. https://www.amgen.com/media/news-releases/2018/07/amgen-and-ucb-resubmit-biologics-license-application-bla-for-evenity-romosozumab-to-the-us-fda/
49. Zhang H, Deng M, Lin P, Liu J, Liu C, Strohl WR, Wang S, Ho M. Frontiers and opportunities: highlights of the 2nd annual conference of the Chinese antibody society. Antib Ther. 2018 Sep;1(2):65–74. doi:10.1093/abt/tby009
50. Zhang T, Song X, Xu L, Ma J, Zhang Y, Gong W, Zhang Y, Zhou X, Wang Z, Wang Y, et al. The binding of an anti-PD-1 antibody to FcγRΙ has a profound impact on its biological functions. Cancer Immunol Immunother. 2018;67(7):1079–1090. doi:10.1007/s00262-018-2160-x
51. Beigene Ltd. BeiGene announces acceptance of new drug application for anti-PD-1 antibody tislelizumab in Hodgkin’s lymphoma in China. August 31, 2018 press release. http://ir.beigene.com/phoenix.zhtml?c=254246&p=irol-newsArticle&ID=2365642
52. Innovent Biologics (Suzhou) Co. Ltd. Innovent biologics announces the study result of its anti-PD-1 antibody in Hodgkin lymphoma May 17, 2018 press release. http://innoventbio.com/en/#/news/102
53. LSK BioPharma, Jiangsu Hengrui Medicine. LSK Biopharma and Jiangsu Hengrui medicine announce global clinical collaboration to evaluate the combination of anti-angiogenesis and immuno-oncology therapy for patients with advanced Hepatocellular Carcinoma (HCC). October 21, 2018 press release. http://lskbiopharma.com/lsk-biopharma-and-jiangsu-hengrui-medicine-announce-global-clinical-collaboration-to-evaluate-the-combination-of-anti-angiogenesis-and-immuno-oncology-therapy-for-patients-with-advanced-hepatocellular/
54. Wang C, Liu Y, Nie J, Shen L, Yang Q, Han W, Safety and efficacy of decitabine-primed anti-PD-1 (SHR-1210) treatment in patients with relapsed/refractory classical Hodgkin lymphoma. 2018 American Society of Clinical Oncology meeting abstract. https://meetinglibrary.asco.org/record/162336/abstract
55. Zhou C, Gao G, Wu F, Chen X, Li W, Xiong A, Su C, Cai W, Ren S, Jiang T, et al. A phase Ib study of SHR-1210 plus apatinib for heavily previously treated advanced non-squamous non-small cell lung cancer (NSCLC) patients. 2018 American Society of Clinical Oncology meeting abstract. https://meetinglibrary.asco.org/record/160803/abstract
56. Xu JM, Zhang Y, Jia R, Yue CY, Chang L, Liu RR, Zhang G, Zhao CH, Zhang YY, Chen CX, et al. Anti-PD-1 antibody SHR-1210 combined with apatinib for advanced hepatocellular carcinoma, gastric or esophagogastric junction cancer: an open-label, dose escalation and expansion study. Clin Cancer Res. 2018 Oct 22;2018:2484. pii: clincanres. doi:10.1158/1078-0432.CCR-18-2484
57. Fang W, Yang Y, Ma Y, Hong S, Lin L, He X, Xiong J, Li P, Zhao H, Huang Y, et al. Camrelizumab (SHR-1210) alone or in combination with gemcitabine plus cisplatin for nasopharyngeal carcinoma: results from two single-arm, phase 1 trials. Lancet Oncol. 2018 Oct;19(10):1338–1350. doi:10.1016/S1470-2045(18)30495-9
58. Huang J, Xu B, Mo H, Zhang W, Chen X, Wu D, Qu D, Wang X, Lan B, Yang B, et al. Safety, activity, and biomarkers of SHR-1210, an anti-PD-1 antibody, for patients with advanced esophageal carcinoma. Clin Cancer Res. 2018;24(6):1296–1304. doi:10.1158/1078-0432.CCR-17-2439
59. Mo H, Huang J, Xu J, Chen X, Wu D, Qu D, Wang X, Lan B, Wang X, Xu J, et al. Safety, anti-tumour activity, and pharmacokinetics of fixed-dose SHR-1210, an anti-PD-1 antibody in advanced solid tumours: a dose-escalation, phase 1 study. Br J Cancer. 2018;119(5):538–545. doi:10.1038/s41416-018-0100-3
60. Scurci I, Martins E, Hartley O. CCR5: established paradigms and new frontiers for a ‘celebrity’ chemokine receptor. Cytokine. 2018;109:.81–93. doi:10.1016/j.cyto.2018.02.018
61. CytoDyn Inc. CytoDyn’s PRO 140 (leronlimab) HIV monotherapy trial results show 92% responder’s rate at 700 mg dose. November 13, 2018 press release. https://www.cytodyn.com/media/press-releases/detail/297/cytodyns-pro-140-leronlimab-hiv-monotherapy-trial
62. Novartis. New analysis of Novartis phase III brolucizumab (RTH258) data reinforces superior reduction of retinal fluid, a key marker of disease activity in nAMD. September 22, 2018 press release. https://www.novartis.com/news/media-releases/new-analysis-novartis-phase-iii-brolucizumab-rth258-data-reinforces-superior-reduction-retinal-fluid-key-marker-disease-activity-namd
63. Novartis. Two-year data for Novartis brolucizumab reaffirm superiority versus aflibercept in reducing retinal fluid in patients with nAMD. October 27, 2018 press release. https://www.novartis.com/news/media-releases/two-year-data-novartis-brolucizumab-reaffirm-superiority-versus-aflibercept-reducing-retinal-fluid-patients-namd
64. Alder Biopharmaceuticals. Alder BioPharmaceuticals® reports third quarter 2018 financial and operating results. November 5, 2018 press release. https://investor.alderbio.com/news-releases/news-release-details/alder-biopharmaceuticalsr-reports-third-quarter-2018-financial
65. Alder Biopharmaceuticals. Transforming the prevention treatment paradigm for migraine patients. November 5, 2018 corporate presentation. https://investor.alderbio.com/index.php/encrypt/files?file=nasdaq_kms/assets/2018/11/06/3-08-52/Corporate%20Deck%20November%205th%20FINAL%20FINAL.pdf&file_alias=18416
66. Alder Biopharmaceuticals. Alder BioPharmaceuticals® presents new one-year data for eptinezumab from PROMISE 1 phase 3 trial demonstrating long-term efficacy in episodic migraine. June 29, 2018 press release. https://investor.alderbio.com/news-releases/news-release-details/alder-biopharmaceuticalsr-presents-new-one-year-data-eptinezumab
67. Alder Biopharmaceuticals. Alder BioPharmaceuticals® presents new six-month data for eptinezumab demonstrating improvement in efficacy in PROMISE 2 phase 3 trial for chronic migraine. June 29, 2018 press release. https://investor.alderbio.com/news-releases/news-release-details/alder-biopharmaceuticalsr-presents-new-six-month-data
68. Horizon Pharma. An overview of Thyroid Eye Disease (TED) and teprotumumab clinical data. October 4, 2018 corporate presentation. http://ir.horizon-pharma.com/static-files/c153d2c9-fae6-4e3b-ab18-7e8485e2c2d4
69. Kato GJ, Piel FB, Reid CD, Gaston MH, Ohene-Frempong K, Krishnamurti L, Smith WR, Panepinto JA, Weatherall DJ, Costa FF, et al. Sickle cell disease. Nat Rev Dis Primers. 2018 Mar 15;4:18010. doi:10.1038/nrdp.2018.10
70. Kutlar A, Kanter J, Liles DK, Alvarez OA, Cançado RD, Friedrisch JR, Knight-Madden JM, Bruederle A, Shi M, Zhu Z, et al. Effect of crizanlizumab on pain crises in subgroups of patients with sickle cell disease: A SUSTAIN study analysis. Am J Hematol. 2018 Oct 8. doi:10.1002/ajh.25308
71. Novartis. Novartis analysis shows crizanlizumab (SEG101) increased the number of patients free of sickle cell pain crises vs placebo during SUSTAIN study. October 9, 2018 press release. https://www.novartis.com/news/media-releases/novartis-analysis-shows-crizanlizumab-seg101-increased-number-patients-free-sickle-cell-pain-crises-vs-placebo-during-sustain-study
72. Chugai Pharmaceutical Co., Ltd. Chugai presents results from phase III study of satralizumab in NMOSD at ECTRIMS 2018. October 15, 2018 press release. https://www.chugai-pharm.co.jp/english/news/detail/20181015120001_561.html
73. Denk F, Bennett DL, McMahon SB. Nerve growth factor and pain mechanisms. Annu Rev Neurosci. 2017;40:.307–325. doi:10.1146/annurev-neuro-072116-031121
74. Pfizer Inc., Eli Lilly and Company. Pfizer and Lilly announce positive top-line results from phase 3 trial of tanezumab for the treatment of Osteoarthritis (OA) pain. July 18, 2018 press release. https://www.pfizer.com/news/press-release/press-release-detail/pfizer_and_lilly_announce_positive_top_line_results_from_phase_3_trial_of_tanezumab_for_the_treatment_of_osteoarthritis_oa_pain
75. Eli Lilly and Company. Form 10-Q quarterly report for the quarter ended June 30, 2018. https://www.sec.gov/Archives/edgar/data/59478/000005947818000188/lly-6302018x10q.htm
76. Sehn LH, Kamdar M, Herrera AF, McMillan A, Flowers C, Kim WS, Kim TM, Ozcan M, Trněný M, Demeter J, et al. Adding polatuzumab vedotin (POLA) to bendamustine and rituximab (BR) treatment improves survival in patients with relapsed/refractory DLBCL: results of a phase 2 clinical trial. 23rd Congress of the European Hematology Association, 2018 June 16; Stockholm, Sweden. https://www.primeoncology.org/app/uploads/hematology-updates-stockholm-2018-dlbcl-s802-sehn.pdf
77. Roche. Roche virtual late stage pipeline event 2018. September 13, 2018 corporate presentation. https://www.roche.com/dam/jcr:8142e2f9-9525-4a8f-ad1f-d5f605e36991/en/irp20180913.pdf
78. Sanofi. Q3 2018 results. October 31, 2018 corporate presentation, slides 38, 41. https://www.sanofi.com/-/media/Project/One-Sanofi-Web/Websites/Global/Sanofi-COM/Home/en/investors/docs/Q-R/Q3_2018_Final_Slides.pdf?la=fr&hash=1746EC206B1D3AEB873C251D8512A5F62C28AE10
79. Richardson PG, Attal M, Campana F, Le-Guennec S, Hui AM, Risse ML, Corzo K, Anderson KC. Isatuximab plus pomalidomide/dexamethasone versus pomalidomide/dexamethasone in relapsed/refractory multiple myeloma: ICARIA phase III study design. Future Oncol. 2018 May;14(11):1035–1047. doi:10.2217/fon-2017-0616
80. Novartis AG, Q2 2018 Results. July 18, 2018 investor presentation, slides 36, 37, 81. https://www.novartis.com/sites/www.novartis.com/files/q2-2018-ir-presentation.pdf
81. Novartis. Q2 results confirm full year guidance. Strong pipeline results underpin potential of several highly innovative products. July 18, 2017 press release. https://www.novartis.com/news/media-releases/q2-results-confirm-full-year-guidance-strong-pipeline-results-underpin-potential
82. Kellner C, Zhukovsky EA, Pötzke A, Brüggemann M, Schrauder A, Schrappe M, Kneba M, Repp R, Humpe A, Gramatzki M, et al. The Fc-engineered CD19 antibody MOR208 (XmAb5574) induces natural killer cell-mediated lysis of acute lymphoblastic leukemia cells from pediatric and adult patients. Leukemia. 2013 Jul;27(7):1595–1598. doi:10.1038/leu.2012.373
83. Morphosys. MorphoSys reports updated data from L-MIND study of MOR208 plus lenalidomide in aggressive lymphoma (r/r DLBCL). March 13, 2018. https://www.morphosys.com/media-investors/media-center/morphosys-reports-updated-data-from-l-mind-study-of-mor208-plus
84. Morphosys. MorphoSys AG announces third quarter 2018 results. November 5, 2018. https://www.morphosys.com/media-investors/media-center/morphosys-ag-announces-third-quarter-2018-results
85. Biggers K, Scheinfeld N. VB4-845, a conjugated recombinant antibody and immunotoxin for head and neck cancer and bladder cancer. Curr Opin Mol Ther. 2008;10(2):176–186
86. Sesen Bio. Sesen Bio announces vicinium granted fast track designation by FDA for treatment of non-muscle invasive bladder cancer. August 09, 2018 press release. https://sesenbio.gcs-web.com/news-releases/news-release-details/sesen-bio-announces-vicinium-granted-fast-track-designation-fda
87. Sesen Bio. Phase 3 registration trial for non-muscle invasive bladder cancer achieves 42% complete response rate at three months in carcinoma in situ patients. May 21, 2018 press release. https://sesenbio.gcs-web.com/news-releases/news-release-details/phase-3-registration-trial-non-muscle-invasive-bladder-cancer
88. Sesen Bio. Sesen Bio reports third quarter 2018 financial results and planned VISTA trial readouts. November 8, 2018 press release. https://sesenbio.gcs-web.com/news-releases/news-release-details/sesen-bio-reports-third-quarter-2018-financial-results-and
89. TESARO, Inc. TESARO announces data presentations at ESMO 2018 congress. October 20, 2018. http://ir.tesarobio.com/news-releases/news-release-details/tesaro-announces-data-presentations-esmo-2018-congress-0
90. Seattle Genetics, Inc. Seattle Genetics and Astellas announce updated enfortumab vedotin phase 1 data in metastatic urothelial cancer at 2017 ASCO annual meeting. June 5, 2017 press release. http://investor.seattlegenetics.com/news-releases/news-release-details/seattle-genetics-and-astellas-announce-updated-enfortumab
91. Seattle Genetics, Inc. Seattle Genetics and Astellas announce progress in enfortumab vedotin urothelial cancer clinical development program. October 25, 2018 press release. http://investor.seattlegenetics.com/news-releases/news-release-details/seattle-genetics-reports-third-quarter-2018-financial-results
92. TG Therapeutics. TG therapeutics announces update regarding UNITY-CLL phase 3 trial. September 25, 2018 press release. http://ir.tgtherapeutics.com/news-releases/news-release-details/tg-therapeutics-announces-update-regarding-unity-cll-phase-3
93. AbbVie. AbbVie announces results from phase 2 study evaluating rovalpituzumab tesirine (Rova-T) for third-line treatment of patients with DLL3-expressing relapsed/refractory small cell lung cancer. March 22, 2018 press release. https://news.abbvie.com/news/abbvie-announces-results-from-phase-2-study-evaluating-rovalpituzumab-tesirine-rova-t-for-third-line-treatment-patients-with-dll3-expressing-relapsedrefractory-small-cell-lung-cancer.htm