表紙:疾患分析:腎細胞がん (RCC)
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1019933

疾患分析:腎細胞がん (RCC)

Disease Analysis: Renal Cell Carcinoma (RCC)

出版日: | 発行: Datamonitor Healthcare | ページ情報: 英文 91 Pages | 納期: 即日から翌営業日

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疾患分析:腎細胞がん (RCC)
出版日: 2021年07月09日
発行: Datamonitor Healthcare
ページ情報: 英文 91 Pages
納期: 即日から翌営業日
  • 全表示
  • 概要
  • 目次
概要

腎細胞がん (RCC) は、腎臓がんの中で最も多く見られるがんで、全症例の90%以上を占めています。また、全世界のがんの2%を占め、米国では新規がん診断の3.5%を占めています。RCC症例の大部分 (75%) は、ほとんどの第一選択治療薬が特化している透明組織型 (ccRCC) です。次に多い組織型は乳頭状RCCで、全体の15%を占めています。

当レポートでは、世界の腎細胞がん (RCC) 向け治療薬の治験情勢と市場動向見通しについて分析し、疾患の概要や疫学的予測、現在の主な治療薬 (上市済み/パイプライン製品) や治験の進行状況、現在のアンメットニーズと将来的な市場機会、治験/市場の先行きに関する専門家の見解、といった情報を取りまとめてお届けいたします。

目次

目次

概要

疾患の背景事情

  • 定義
  • リスク要因
  • 症状
  • 診断
  • 患者の分類
  • 予後

治療法

  • 紹介パターン
  • 局所領域疾患向けに推奨される薬物療法
  • 転移性ccRCC (透明RCC) 向けに推奨される第一選択レジメン
  • 転移性ccRCC (透明RCC) 向けの好ましい第二選択レジメン
  • 転移性非ccRCC (非透明RCC) 向けの好ましい薬物療法

疫学

  • 発生率の分析手法

市販薬

パイプライン薬

規制上の主な動き

成功の可能性

ライセンス契約/資産買収取引

治験環境

  • 治験依頼者の分類:状況別
  • 治験依頼者の分類:相別 (フェーズ別)
  • 昨今の動向

医薬品の評価モデル

市場力学

将来の動向

  • TKI:併用療法向けの一般的な処方オプションとして残る見通し
  • Sutent:新しい治療法に取って代わられる可能性
  • 抗PD-1/PD-L1療法に耐性のある患者向けの選択肢が広がる可能性
  • 転移性ccRCC向け第一選択治療薬を巡る競合の激化
  • 局所進行腫瘍の補助療法向けICIの発売競争

コンセンサス予測

近年の市場動向とアナリストの見解

  • Telaglenastat:腎細胞がん向け (2021年6月7日)
  • 腎細胞がん向けの複数の薬剤 (2021年6月4日)
  • Keytruda:腎細胞がん向け (2021年6月3日)
  • Keytruda:腎細胞がん向け (2021年4月8日)
  • Ilixadencel:腎細胞がん向け (2021年2月22日)
  • Lenvima:腎細胞がん向け (2021年2月13日)
  • Telaglenastat:腎細胞がん向け (2021年1月4日)
  • 腎細胞がん向けの複数の薬剤 (2020年11月10日)
  • 腎細胞がん向けの複数の薬剤 (2020年9月19日)
  • Ilixadencel:腎細胞がん向け (2020年8月18日)
  • Tivopath:腎細胞がん向け (2020年5月29日)
  • Belzutifan:腎細胞がん向け (2020年5月13日)
  • Opdivo:腎細胞がん向け (2020年4月20日)

今後の市場の主な動き

KOL (専門家) の見解

アンメットニーズ

参考文献

付録

図の一覧

表の一覧

目次
Product Code: DMKC0216911

Disease Overview

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.

Latest key takeaways

Datamonitor Healthcare 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 after showing 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 is infrequently used but 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 one or more of these agents could finally displace Sutent and perhaps renew interest in adjuvant treatment of locally advanced RCC. Recently, the KEYNOTE-564 trial of adjuvant Keytruda recorded a 32% reduction in disease recurrence or death against placebo, becoming the first PD-1 antibody to demonstrate a conclusive benefit in the setting.

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 also 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.

TABLE OF CONTENTS

CONTENTS

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 DRUGS

PIPELINE DRUGS

KEY REGULATORY EVENTS

  • More US FDA Enforcement Of Clinical Trial Reporting Is Expected After Acceleron's 'Clerical Oversight'
  • Biocon And Viatris Ready To Launch EU Bevacizumab
  • FDA Accepts New Drug Application For Merck's Belzutifan
  • Persistence Pays Off With US Approval Of Aveo's Fotivda In RCC
  • 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

PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS

  • Kazia Therapeutics Acquires Worldwide License to Evotec's VEGFR3 Receptor Inhibitor
  • Could SillaJen Get Back On Track Via M2N's Acquisition?
  • 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

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 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

  • Telaglenastat for Renal Cell Cancer (June 7, 2021)
  • Multiple Drugs for Renal Cell Cancer (June 4, 2021)
  • Keytruda for Renal Cell Cancer (June 3, 2021)
  • Keytruda for Renal Cell Cancer (April 8, 2021)
  • 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 EVENTS

KEY OPINION LEADER INSIGHTS

UNMET NEEDS

BIBLIOGRAPHY

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: 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: Cabometyx / Cometriq and Opdivo for Renal Cell Cancer (June 4, 2021): Phase II - w/Cabozantinib + Nivolumab - Non-Clear Cell RCC (MSKCC)
  • Figure 22: Keytruda for Renal Cell Cancer (June 3, 2021): Phase III - KEYNOTE-564
  • Figure 23: Ilixadencel for Renal Cell Cancer (February 22, 2021): Phase II - MERECA
  • Figure 24: Lenvima for Renal Cell Cancer (February 13, 2021): Phase III - CLEAR (First Line)
  • Figure 25: Telaglenastat for Renal Cell Cancer (January 4, 2021): Phase II - CANTATA (w/Cabozantinib)
  • Figure 26: Cabometyx / Cometriq and Opdivo for Renal Cell Cancer (September 19, 2020): Phase III - CheckMate 9ER
  • Figure 27: Tivopath for Renal Cell Cancer (May 29, 2020): Phase III - TIVO-3
  • Figure 28: Belzutifan for Renal Cell Cancer (May 13, 2020): Phase II - VHL-Associated RCC
  • Figure 29: Opdivo for Renal Cell Cancer (April 20, 2020): Phase III - CheckMate 9ER (w/Cabozantinib)
  • Figure 30: Key upcoming events in renal cell carcinoma
  • Figure 31: 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 ($m), 2016-20
  • Table 7: Forecasted global sales, by drug ($m), 2021-25
  • Table 8: Telaglenastat for Renal Cell Cancer (June 7, 2021)
  • Table 9: Multiple Drugs for Renal Cell Cancer (June 4, 2021)
  • Table 10: Keytruda for Renal Cell Cancer (June 3, 2021)
  • Table 11: Keytruda for Renal Cell Cancer (April 8, 2021)
  • Table 12: Ilixadencel for Renal Cell Cancer (February 22, 2021)
  • Table 13: Lenvima for Renal Cell Cancer (February 13, 2021)
  • Table 14: Telaglenastat for Renal Cell Cancer (January 4, 2021)
  • Table 15: Multiple Drugs for Renal Cell Cancer (November 10, 2020)
  • Table 16: Multiple Drugs for Renal Cell Cancer (September 19, 2020)
  • Table 17: Ilixadencel for Renal Cell Cancer (August 18, 2020)
  • Table 18: Tivopath for Renal Cell Cancer (May 29, 2020)
  • Table 19: Belzutifan for Renal Cell Cancer (May 13, 2020)
  • Table 20: Opdivo for Renal Cell Cancer (April 20, 2020)