Renal cell carcinoma (RCC) is defined as a kidney cancer where the primary tumor emerges in renal tubular epithelial cells. This distinguishes RCC from other cancers of the renal parenchyma and renal pelvis cancers. RCC is the most common form of kidney cancer, comprising over 90% of all cases. RCC accounts for 2% of cancers worldwide, and 3.5% of new cancer diagnoses in the US.
Although all RCCs have the same point of origin, they are histologically diverse with multiple identified tumor types. By far the most common tumor type, however, is clear cell RCC (ccRCC), which accounts for 75% of all RCC incidences.
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
14 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
37 KEY REGULATORY EVENTS
37 Non-Inferiority Is Not Sufficient Foundation For Allarity’s Dovitinib NDA
37 Adjuvant Boost For Keytruda In Renal Cancer
37 New Indications For Keytruda And Lenvima In The EU
37 Keeping Track: Merck & Co. In Spotlight With Welireg, Keytruda Approvals
38 More US FDA Enforcement Of Clinical Trial Reporting Is Expected After Acceleron’s ‘Clerical Oversight’
38 Biocon And Viatris Ready To Launch EU Bevacizumab
39 FDA Accepts New Drug Application For Merck’s Belzutifan
39 Persistence Pays Off With US Approval Of Aveo’s Fotivda In RCC
39 Six Drugs Recommended For EU-Wide Use
40 PROBABILITY OF SUCCESS
41 LICENSING AND ASSET ACQUISITION DEALS
41 Recordati Expands Into Rare Cancer Space With EUSA Pharma Buy
41 MS Pharma Partners With Mabxience For Bevacizumab In MENA Region
41 Osel Obtains Worldwide Rights To LBP CBM588 From City Of Hope
41 Kazia Therapeutics Acquires Worldwide License to Evotec’s VEGFR3 Receptor Inhibitor
42 Could SillaJen Get Back On Track Via M2N’s Acquisition?
43 CLINICAL TRIAL LANDSCAPE
44 Sponsors by status
45 Sponsors by phase
46 Recent events
48 DRUG ASSESSMENT MODEL
53 MARKET DYNAMICS
54 FUTURE TRENDS
54 TKIs will remain a common prescribing option when used in combination
54 Sutent to be largely replaced by newer therapies
55 Patients resistant to anti-PD-1/PD-L1 therapy may have more options
55 Competition in first-line metastatic ccRCC will intensify
55 Race for ICI launch in adjuvant treatment of locally advanced tumors
57 CONSENSUS FORECASTS
62 RECENT EVENTS AND ANALYST OPINION
62 ALLO-316 for Renal Cell Cancer (January 10, 2022)
63 ALLO-316 for Renal Cell Cancer (October 7, 2021)
64 Telaglenastat for Renal Cell Cancer (June 7, 2021)
65 Multiple Drugs for Renal Cell Cancer (June 4, 2021)
66 Keytruda for Renal Cell Cancer (June 3, 2021)
67 Keytruda for Renal Cell Cancer (April 8, 2021)
68 Ilixadencel for Renal Cell Cancer (February 22, 2021)
70 Lenvima for Renal Cell Cancer (February 13, 2021)
71 Telaglenastat for Renal Cell Cancer (January 4, 2021)
73 Multiple Drugs for Renal Cell Cancer (November 10, 2020)
73 Multiple Drugs for Renal Cell Cancer (September 19, 2020)
76 KEY UPCOMING EVENTS
77 KEY OPINION LEADER INSIGHTS
78 UNMET NEEDS
79 BIBLIOGRAPHY
80 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 clear cell 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
30 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
48 Figure 18: Datamonitor Healthcare’s drug assessment summary for renal cell carcinoma
53 Figure 19: Market dynamics in renal cell carcinoma
54 Figure 20: Future trends in renal cell carcinoma
66 Figure 21: Cabometyx / Cometriq and Opdivo for Renal Cell Cancer (June 4, 2021): Phase II – w/Cabozantinib + Nivolumab -Non-Clear Cell RCC (MSKCC)
67 Figure 22: Keytruda for Renal Cell Cancer (June 3, 2021): Phase III – KEYNOTE-564
70 Figure 23: Ilixadencel for Renal Cell Cancer (February 22, 2021): Phase II – MERECA
71 Figure 24: Lenvima for Renal Cell Cancer (February 13, 2021): Phase III – CLEAR (First Line)
73 Figure 25: Telaglenastat for Renal Cell Cancer (January 4, 2021): Phase II – CANTATA (w/Cabozantinib)
75 Figure 26: Cabometyx / Cometriq and Opdivo for Renal Cell Cancer (September 19, 2020): Phase III – CheckMate 9ER
76 Figure 27: Key upcoming events in renal cell carcinoma
78 Figure 28: 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
58 Table 6: Historical global sales, by drug ($m), 2016–20
60 Table 7: Forecasted global sales, by drug ($m), 2022–26
62 Table 8: ALLO-316 for Renal Cell Cancer (January 10, 2022)
63 Table 9: ALLO-316 for Renal Cell Cancer (October 7, 2021)
64 Table 10: Telaglenastat for Renal Cell Cancer (June 7, 2021)
65 Table 11: Multiple Drugs for Renal Cell Cancer (June 4, 2021)
66 Table 12: Keytruda for Renal Cell Cancer (June 3, 2021)
68 Table 13: Keytruda for Renal Cell Cancer (April 8, 2021)
69 Table 14: Ilixadencel for Renal Cell Cancer (February 22, 2021)
70 Table 15: Lenvima for Renal Cell Cancer (February 13, 2021)
72 Table 16: Telaglenastat for Renal Cell Cancer (January 4, 2021)
73 Table 17: Multiple Drugs for Renal Cell Cancer (November 10, 2020)
74 Table 18: Multiple Drugs for Renal Cell Cancer (September 19, 2020)
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