CONTENTS

7 OVERVIEW

7 Latest key takeaways

9 DISEASE BACKGROUND

9 Definition

9 Risk factors

10 Symptoms

10 Diagnosis

11 Patient segmentation

12 Prognosis

13 TREATMENT

13 Referral patterns

13 Recommended pharmacological therapy for locoregional disease

13 Recommended first-line regimens for metastatic ccRCC

14 Preferred subsequent-line regimens for metastatic ccRCC

15 Preferred pharmacological therapy for metastatic non-ccRCC

19 EPIDEMIOLOGY

19 Incidence methodology

23 MARKETED DRUGS

28 PIPELINE DRUGS

36 KEY REGULATORY EVENTS

36 Six Drugs Recommended For EU-Wide Use

36 Exelixis Has Renewed Momentum Heading Into 2021

36 Stada-Mabxience Bevacizumab Is Latest To Receive EU Nod

36 Accord Picks Up European Nods

37 Mystery Surrounds Second Samsung Bioepis Avastin Biosimilar

37 SMC Recommends Bavencio/Axitinib Combo For Advanced RCC

37 Centus Gets European Bevacizumab Approval

38 Samsung Bioepis Receives EU Bevacizumab Approval

38 MK-6482 Brings New Mechanism To Merck's Renal Cancer Franchise

38 Centus Biotherapeutics's Equidacent Gets CHMP Nod

38 Samsung Bioepis' Bevacizumab Nod Sets Stage For EU Throwdown

39 Second Submission for Aveo Pharmaceuticals' Targeted Therapy, Tivozanib

39 Mylan Reveals FDA Goal Date for Bevacizumab

40 PROBABILITY OF SUCCESS

41 LICENSING AND ASSET ACQUISITION DEALS

41 Immunotech Obtains Chinese Rights To T-Cure's RCC Candidate

41 Biomm Backs Bio-Thera's Brazilian Bevacizumab

41 Bristol Licenses Dragonfly's IL-12 Program To Boost Immunotherapies

41 Zydus Cadila Joins IO Therapy League With XOMA Tie-up

43 CLINICAL TRIAL LANDSCAPE

44 Sponsors by status

45 Sponsors by phase

46 Recent events

49 DRUG ASSESSMENT MODEL

54 MARKET DYNAMICS

55 FUTURE TRENDS

55 TKIs will remain a common prescribing option when used in combination

55 Sutent to be largely replaced by newer therapies

56 Patients resistant to anti-PD-1/PD-L1 therapy may have more options

56 Competition in first-line metastatic ccRCC will intensify

56 Race for ICI launch in adjuvant treatment of locally advanced tumors

58 CONSENSUS FORECASTS

62 RECENT EVENTS AND ANALYST OPINION

62 Ilixadencel for Renal Cell Cancer (February 22, 2021)

63 Lenvima for Renal Cell Cancer (February 13, 2021)

64 Telaglenastat for Renal Cell Cancer (January 4, 2021)

66 Multiple Drugs for Renal Cell Cancer (November 10, 2020)

66 Multiple Drugs for Renal Cell Cancer (September 19, 2020)

68 Ilixadencel for Renal Cell Cancer (August 18, 2020)

69 Tivopath for Renal Cell Cancer (May 29, 2020)

71 Belzutifan for Renal Cell Cancer (May 13, 2020)

73 Opdivo for Renal Cell Cancer (April 20, 2020)

76 KEY UPCOMING EVENTS

77 KEY OPINION LEADER INSIGHTS

78 UNMET NEEDS

79 BIBLIOGRAPHY

79 Prescription information

81 APPENDIX

LIST OF FIGURES

12 Figure 1: AJCC prognostic groups for renal cell carcinoma

12 Figure 2: Definitions of the diagnostic criteria for primary tumor (T), regional lymph nodes (N), and distant metastasis (M) in kidney cancer

14 Figure 3: First-line therapy for clear cell renal cell carcinoma

15 Figure 4: Subsequent-line therapy for renal cell carcinoma

16 Figure 5: First-line therapy for non-clear cell renal cell carcinoma

21 Figure 6: Trends in incident cases of renal cell carcinoma, 2018-27

28 Figure 7: Overview of pipeline drugs for renal cell carcinoma in the US

29 Figure 8: Pipeline drugs for renal cell carcinoma, by company

29 Figure 9: Pipeline drugs for renal cell carcinoma, by drug type

29 Figure 10: Pipeline drugs for renal cell carcinoma, by classification

40 Figure 11: Probability of success in the renal cell carcinoma pipeline

43 Figure 12: Clinical trials in renal cancer

43 Figure 13: Top 10 drugs for clinical trials in renal cancer

44 Figure 14: Top 10 companies for clinical trials in renal cancer

44 Figure 15: Trial locations in renal cancer

45 Figure 16: Renal cancer trials status

46 Figure 17: Renal cancer trials sponsors, by phase

49 Figure 18: Datamonitor Healthcare's drug assessment summary for renal cell carcinoma

54 Figure 19: Market dynamics in renal cell carcinoma

55 Figure 20: Future trends in renal cell carcinoma

63 Figure 21: Ilixadencel for Renal Cell Cancer (February 22, 2021): Phase II - MERECA

64 Figure 22: Lenvima for Renal Cell Cancer (February 13, 2021): Phase III - CLEAR (First Line)

66 Figure 23: Telaglenastat for Renal Cell Cancer (January 4, 2021): Phase II - CANTATA (w/Cabozantinib)

68 Figure 24: Cabometyx / Cometriq and Opdivo for Renal Cell Cancer (September 19, 2020): Phase III - CheckMate 9ER

71 Figure 25: Tivopath for Renal Cell Cancer (May 29, 2020): Phase III - TIVO-3

73 Figure 26: Belzutifan for Renal Cell Cancer (May 13, 2020): Phase II - VHL-Associated RCC

75 Figure 27: Opdivo for Renal Cell Cancer (April 20, 2020): Phase III - CheckMate 9ER (w/Cabozantinib)

76 Figure 28: Key upcoming events in renal cell carcinoma

78 Figure 29: Unmet needs in renal cell carcinoma

LIST OF TABLES

17 Table 1: Preferred/recommended branded treatment regimens for patients with renal cell carcinoma

20 Table 2: Incident cases of renal cell carcinoma, 2018-27

22 Table 3: Incident cases of renal cell carcinoma, by gender, 2018

24 Table 4: Marketed drugs for renal cell carcinoma

31 Table 5: Pipeline drugs for renal cell carcinoma in the US

59 Table 6: Historical global sales, by drug ($m), 2015-19

60 Table 7: Forecasted global sales, by drug ($m), 2021-25

62 Table 8: Ilixadencel for Renal Cell Cancer (February 22, 2021)

63 Table 9: Lenvima for Renal Cell Cancer (February 13, 2021)

65 Table 10: Telaglenastat for Renal Cell Cancer (January 4, 2021)

66 Table 11: Multiple Drugs for Renal Cell Cancer (November 10, 2020)

67 Table 12: Multiple Drugs for Renal Cell Cancer (September 19, 2020)

68 Table 13: Ilixadencel for Renal Cell Cancer (August 18, 2020)

70 Table 14: Tivopath for Renal Cell Cancer (May 29, 2020)

72 Table 15: Belzutifan for Renal Cell Cancer (May 13, 2020)
74 Table 16: Opdivo for Renal Cell Cancer (April 20, 2020)