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Renal Cell Cancer (RCC) Disease Forecast and Market Analysis to 2038

  • ID: 3797427
  • Report
  • April 2021
  • Region: Global
  • 74 Pages
  • Pharma Intelligence
Latest Key Takeaways

  • 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 has been boosted by the approval of the CheckMate 9ER regimen and remains the only drug of its class in subsequent-line settings.
  • Combinations of checkpoint inhibitors and TKIs dominate in first-line ccRCC. Opdivo is approved in combination with Yervoy or Cabometyx, while Keytruda and Bavencio are approved in combination with Inlyta. Moreover, a similar doublet of Keytruda and Lenvima is also likely to be launched.
  • Sutent is set to lose ground due to both newer, more effective treatments and 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 is also threatened by the expansion of ICIs for postoperative treatment 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 less common 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 and in combination with Opdivo in first-line disease, Cabometyx has prospective label expansions as a combination therapy alongside Tecentriq, and alongside 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 erosion from bevacizumab biosimilars, 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 the potential first-in-class launch of the HIF-2α antagonist belzutifan.
Note: Product cover images may vary from those shown

OVERVIEW
  • Latest key takeaways

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 DRUGSPIPELINE DRUGS
KEY REGULATORY EVENTS
  • Six Drugs Recommended For EU-Wide Use
  • Exelixis Has Renewed Momentum Heading Into 2021
  • Stada-Mabxience Bevacizumab Is Latest To Receive EU Nod
  • Accord Picks Up European Nods
  • Mystery Surrounds Second Samsung Bioepis Avastin Biosimilar
  • SMC Recommends Bavencio/Axitinib Combo For Advanced RCC
  • Centus Gets European Bevacizumab Approval
  • 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

PROBABILITY OF SUCCESS
LICENSING AND ASSET ACQUISITION DEALS
  • Immunotech Obtains Chinese Rights To T-Cure’s RCC Candidate
  • Biomm Backs Bio-Thera’s Brazilian Bevacizumab
  • Bristol Licenses Dragonfly’s IL-12 Program To Boost Immunotherapies
  • Zydus Cadila Joins IO Therapy League With XOMA Tie-up

CLINICAL TRIAL LANDSCAPE
  • Sponsors by status
  • Sponsors by phase
  • Recent events

DRUG ASSESSMENT MODELMARKET DYNAMICS
FUTURE TRENDS
  • TKIs will remain a common prescribing option when used in combination
  • Sutent to be largely replaced by newer therapies
  • 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 (February 22, 2021)
  • Lenvima for Renal Cell Cancer (February 13, 2021)
  • Telaglenastat for Renal Cell Cancer (January 4, 2021)
  • Multiple Drugs for Renal Cell Cancer (November 10, 2020)
  • Multiple Drugs for Renal Cell Cancer (September 19, 2020)
  • Ilixadencel for Renal Cell Cancer (August 18, 2020)
  • Tivopath for Renal Cell Cancer (May 29, 2020)
  • Belzutifan for Renal Cell Cancer (May 13, 2020)
  • Opdivo for Renal Cell Cancer (April 20, 2020)

KEY UPCOMING EVENTSKEY OPINION LEADER INSIGHTSUNMET 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 cancer
Figure 13: Top 10 drugs for clinical trials in renal cancer
Figure 14: Top 10 companies for clinical trials in renal cancer
Figure 15: Trial locations in renal cancer
Figure 16: Renal cancer trials status
Figure 17: Renal cancer trials sponsors, by phase
Figure 18: The publisher’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: Ilixadencel for Renal Cell Cancer (February 22, 2021): Phase II - MERECA
Figure 22: Lenvima for Renal Cell Cancer (February 13, 2021): Phase III - CLEAR (First Line)
Figure 23: Telaglenastat for Renal Cell Cancer (January 4, 2021): Phase II - CANTATA (w/Cabozantinib)
Figure 24: Cabometyx / Cometriq and Opdivo for Renal Cell Cancer (September 19, 2020): Phase III - CheckMate 9ER
Figure 25: Tivopath for Renal Cell Cancer (May 29, 2020): Phase III - TIVO-3
Figure 26: Belzutifan for Renal Cell Cancer (May 13, 2020): Phase II - VHL-Associated RCC
Figure 27: Opdivo for Renal Cell Cancer (April 20, 2020): Phase III - CheckMate 9ER (w/Cabozantinib)
Figure 28: Key upcoming events in renal cell carcinoma
Figure 29: 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), 2021–25
Table 8: Ilixadencel for Renal Cell Cancer (February 22, 2021)
Table 9: Lenvima for Renal Cell Cancer (February 13, 2021)
Table 10: Telaglenastat for Renal Cell Cancer (January 4, 2021)
Table 11: Multiple Drugs for Renal Cell Cancer (November 10, 2020)
Table 12: Multiple Drugs for Renal Cell Cancer (September 19, 2020)
Table 13: Ilixadencel for Renal Cell Cancer (August 18, 2020)
Table 14: Tivopath for Renal Cell Cancer (May 29, 2020)
Table 15: Belzutifan for Renal Cell Cancer (May 13, 2020)
Table 16: Opdivo for Renal Cell Cancer (April 20, 2020)
Note: Product cover images may vary from those shown