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Renal cell cancer (RCC) disease forecast and market analysis to 2038

  • ID: 3797427
  • Report
  • October 2020
  • Region: Global
  • 79 pages
  • Datamonitor Healthcare
Disease Overview

The publisher estimates that in 2018, there were 338,000 incident cases of renal cell carcinoma (RCC) worldwide in those aged 40 years and older, and forecasts that number to increase to 384,000 cases by 2027.

The majority (75%) of RCC cases have a clear cell histology (ccRCC), to which most first-line treatment regimens are specialized. The next most common histology is papillary RCC, comprising 15% of RCCs.

Nearly all pharmacological interventions are administered in metastatic RCC. Sutent may occasionally be prescribed as a postoperative adjuvant therapy in locoregional disease, but the typical approach is nephrectomy alone.

Patients receiving first-line treatment are organized by prognostic risk criteria, as determined by several clinical parameters. This is used to stratify patients into poor, intermediate, and favorable risk categories, which subsequently guide physicians in choosing the appropriate treatment regimen.

The most prominent drug class in RCC currently is tyrosine kinase inhibitors (TKIs). While Nexavar inhibits both intracellular and cell surface kinases, other agents (Sutent, Votrient, Lenvima, Cabometyx, and Inlyta) block members of the receptor tyrosine kinase (RTK) superfamily associated with angiogenesis and tumor cell proliferation, most notably VEGFR and PDGFR. In addition to targeting VEGFR/PDGFR, Cabometyx targets the RTKs MET and AXL. Inlyta and Tivopath, on the other hand, are specific for members of the VEGFR family.

Other drug classes in RCC include inhibitors of the mammalian target of rapamycin (mTOR), a serine-threonine kinase. The mTOR pathway is dysregulated in several human cancers, and Afinitor (an mTOR inhibitor) was the first pharmacological agent available as a therapy for subsequent-line metastatic RCC. Inhibition of mTOR has also been shown to reduce expression of VEGF.

PD-1 antagonist Opdivo was the first immune checkpoint inhibitor (ICI) approved in RCC and has quickly become a standard of care (SOC) in many treatment settings following demonstrable clinical benefits over earlier therapies. Recently, the agent has been challenged in first-line ccRCC by rival PD-1/PD-L1 antagonists Keytruda and Bavencio, but remains the only drug of its class in subsequent-line settings.

Combinations dominate in first-line ccRCC. Opdivo is approved in combination with Yervoy, and recently reported positive Phase III results in combination with Cabometyx. Keytruda and Bavencio are approved in combination with Inlyta.

Sutent is set to lose ground to both newer and more effective treatments, and to imminent biosimilar erosion. Previously the SOC across many treatment settings, the pivotal trials of several newer therapies, which include checkpoint inhibitors Keytruda, Opdivo, and Bavencio, and the RTK inhibitor Cabometyx, have demonstrated significant clinical benefit over Sutent in the first-line setting. Keytruda and Cabometyx have also demonstrated benefit over Sutent in subsequent-line settings.

Sutent may soon be displaced by the prospective label expansions of several ICIs into the adjuvant setting of locoregional disease, where it has largely been able to avoid competition. Approval in this area has proven difficult, with several other TKIs previously failing to expand into the setting. Due to concern over its risk/benefit profile, Sutent is only listed as a Category 3 treatment in this setting by the NCCN, and was rejected by the EMA. It is thus infrequently administered. Phase III trials of ICIs Keytruda, Opdivo, and Tecentriq are ongoing and, if positive, one or more of these agents could finally displace Sutent and perhaps renew interest in adjuvant treatment of locally advanced RCC.

Sutent, along with Cabometyx, remains commonly prescribed in first-line non-ccRCC, although this is partly due to a lack of data for newer treatments in the more uncommon histological subtypes of RCC. Opdivo and Yervoy are the only checkpoint inhibitors available in this setting but are only recommended for sarcomatoid RCCs.

mTOR inhibitors along with most TKI monotherapies are being gradually eclipsed in metastatic RCC by ICI-based combination therapies. However, some TKIs will be able to retain market share through incorporation into these combination regimens. This has been the case with Inlyta, which has seen improved uptake through use in first-line combination therapies that also incorporate checkpoint inhibitors Keytruda and Bavencio.

A minority of other TKIs are also well positioned to improve their uptake through use as combination therapies alongside checkpoint inhibitors, in a similar manner to Inlyta. Already well appraised as a monotherapy in second-line disease, it has prospective label expansions as a combination therapy alongside Opdivo, Tecentriq, and pipeline histone deacetylase inhibitor abexinostat. Similarly, Lenvima, presently available either as a monotherapy or a combination therapy with everolimus, may also be employed in the coming years in a combination therapy alongside Keytruda.

Many older drugs are subject to patent expiries. VEGF inhibitor Avastin is already facing biosimilar erosion, and the mTOR inhibitor Afinitor has been widely genericized. Other drugs set to follow in the near future include mTOR inhibitor Torisel along with TKIs Sutent, Nexavar, and Votrient.

Pipeline therapies of note include the PD-L1 inhibitor Tecentriq and potential first-in-class launches of the HIF-2α antagonist MK-6482 and glutaminase antagonist telaglenastat.
Note: Product cover images may vary from those shown
OVERVIEW

DISEASE BACKGROUND
  • Definition
  • Risk factors
  • Symptoms
  • Diagnosis
  • Patient segmentation
  • Prognosis
TREATMENT
  • Referral patterns
  • Recommended pharmacological therapy for locoregional disease
  • Recommended first-line regimens for metastatic ccRCC
  • Preferred subsequent-line regimens for metastatic ccRCC
  • Preferred pharmacological therapy for metastatic non-ccRCC
EPIDEMIOLOGY
  • Incidence methodology
MARKETED DRUGS

PIPELINE DRUGS

KEY REGULATORY EVENTS
  • Samsung Bioepis Receives EU Bevacizumab Approval
  • MK-6482 Brings New Mechanism To Merck’s Renal Cancer Franchise
  • Centus Biotherapeutics’s Equidacent Gets CHMP Nod
  • Samsung Bioepis’ Bevacizumab Nod Sets Stage For EU Throwdown
  • Second Submission for Aveo Pharmaceuticals’ Targeted Therapy, Tivozanib
  • Mylan Reveals FDA Goal Date for Bevacizumab
  • NICE Rejects Keytruda/Inlyta Combo First-Line In RCC
  • EMA OKs Seven New Drugs But Delivers Another Blow To Emmaus
PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS
  • Bristol Licenses Dragonfly’s IL-12 Program To Boost Immunotherapies
  • Zydus Cadila Joins IO Therapy League With XOMA Tie-up
  • IO-Focused CoImmune, Formula Merge In All-Stock Deal
  • Immuno-Oncology Continues To Draw Pharma Companies To The Deal Table
CLINICAL TRIAL LANDSCAPE
  • Sponsors by status
  • Sponsors by phase
  • Recent events
  • DRUG ASSESSMENT MODEL
MARKET DYNAMICS

FUTURE TRENDS
  • TKIs will remain a common prescribing option when used in combination
  • Sutent poised to lose status as standard of care
  • Patients resistant to anti-PD-1/PD-L1 therapy may have more options
  • Competition in first-line metastatic ccRCC will intensify
  • Race for ICI launch in adjuvant treatment of locally advanced tumors
CONSENSUS FORECASTS

RECENT EVENTS AND ANALYST OPINION
  • Ilixadencel for Renal Cell Cancer (August 18, 2020)
  • Tivopath for Renal Cell Cancer (May 29, 2020)
  • MK-6482 for Renal Cell Cancer (May 13, 2020)
  • Opdivo for Renal Cell Cancer (April 20, 2020)
  • Pegilodecakin for Renal Cell Cancer (January 30, 2020)
  • Mavorixafor for Renal Cell Cancer (September 30, 2019)
  • MK-6482 for Renal Cell Cancer (September 29, 2019)
  • Intuvax for Renal Cell Cancer (September 25, 2019)
  • Tivopath for Renal Cell Cancer (September 23, 2019)
  • Tivopath for Renal Cell Cancer (September 10, 2019)
KEY UPCOMING EVENTS

KEY OPINION LEADER INSIGHTS

UNMET NEEDS

BIBLIOGRAPHY
  • Prescription information
APPENDIX

LIST OF FIGURES
Figure 1: AJCC prognostic groups for renal cell carcinoma
Figure 2: Definitions of the diagnostic criteria for primary tumor (T), regional lymph nodes (N), and distant metastasis (M) in kidney cancer
Figure 3: First-line therapy for clear cell renal cell carcinoma
Figure 4: Subsequent-line therapy for renal cell carcinoma
Figure 5: First-line therapy for non-clear cell renal cell carcinoma
Figure 6: Trends in incident cases of renal cell carcinoma, 2018-27
Figure 7: Overview of pipeline drugs for renal cell carcinoma in the US
Figure 8: Pipeline drugs for renal cell carcinoma, by company
Figure 9: Pipeline drugs for renal cell carcinoma, by drug type
Figure 10: Pipeline drugs for renal cell carcinoma, by classification
Figure 11: Probability of success in the renal cell carcinoma pipeline
Figure 12: Clinical trials in renal cell carcinoma
Figure 13: Top 10 drugs for clinical trials in renal cell carcinoma
Figure 14: Top 10 companies for clinical trials in renal cell carcinoma
Figure 15: Trial locations in renal cell carcinoma
Figure 16: Renal cell carcinoma trials status
Figure 17: Renal cell carcinoma trials sponsors, by phase
Figure 18: Datamonitor Healthcare’s drug assessment summary for renal cell carcinoma
Figure 19: Market dynamics in renal cell carcinoma
Figure 20: Future trends in renal cell carcinoma
Figure 21: Tivopath for Renal Cell Cancer (May 29, 2020): Phase III - TIVO-3
Figure 22: MK-6482 for Renal Cell Cancer (May 13, 2020): Phase II - VHL-Associated RCC
Figure 23: Opdivo for Renal Cell Cancer (April 20, 2020): Phase III - CheckMate 9ER (w/Cabozantinib)
Figure 24: Mavorixafor for Renal Cell Cancer (September 30, 2019): Phase I/IIa - w/Axitinib (RCCA)
Figure 25: Tivopath for Renal Cell Cancer (September 23, 2019): Phase Ib/II - TiNivo (w/Opdivo)
Figure 26: Tivopath for Renal Cell Cancer (September 10, 2019): Phase III - TIVO-3
Figure 27: Key upcoming events in renal cell carcinoma
Figure 28: Unmet needs in renal cell carcinoma

LIST OF TABLES
Table 1: Preferred/recommended branded treatment regimens for patients with renal cell carcinoma
Table 2: Incident cases of renal cell carcinoma, 2018-27
Table 3: Incident cases of renal cell carcinoma, by gender, 2018
Table 4: Marketed drugs for renal cell carcinoma
Table 5: Pipeline drugs for renal cell carcinoma in the US
Table 6: Historical global sales, by drug ($m), 2015-19
Table 7: Forecasted global sales, by drug ($m), 2020-24
Table 8: Ilixadencel for Renal Cell Cancer (August 18, 2020)
Table 9: Tivopath for Renal Cell Cancer (May 29, 2020)
Table 10: MK-6482 for Renal Cell Cancer (May 13, 2020)
Table 11: Opdivo for Renal Cell Cancer (April 20, 2020)
Table 12: Pegilodecakin for Renal Cell Cancer (January 30, 2020)
Table 13: Mavorixafor for Renal Cell Cancer (September 30, 2019)
Table 14: MK-6482 for Renal Cell Cancer (September 29, 2019)
Table 15: Intuvax for Renal Cell Cancer (September 25, 2019)
Table 16: Tivopath for Renal Cell Cancer (September 23, 2019)
Table 17: Tivopath for Renal Cell Cancer (September 10, 2019)
Note: Product cover images may vary from those shown
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