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疾患分析:卵巣癌

Disease Analysis: Ovarian Cancer

発行 Datamonitor Healthcare 商品コード 939970
出版日 ページ情報 英文 109 Pages
納期: 即日から翌営業日
価格
本日の銀行送金レート: 1USD=106.59円で換算しております。
疾患分析:卵巣癌 Disease Analysis: Ovarian Cancer
出版日: 2020年04月01日 ページ情報: 英文 109 Pages
概要

2018年に世界中で15歳以上の女性に293,300件の卵巣癌の症例が発生したと推定され、その数は2027年までに319,500例に増加すると予測されています。高度に一般化された白金製剤による化学療法は、依然として新たに診断された患者と再発した白金系抗癌剤感受性の卵巣癌患者両方に対する標準治療となっています。

当レポートでは、卵巣癌について調査し、疾患の背景と患者動向、治療ガイドライン、薬剤動向、治験動向、将来の動向などについてまとめています。

目次

概要

  • 最新の要点

疾患の背景

  • 定義
  • 予後
  • 危険因子
  • 症状
  • 診断
  • 患者のセグメンテーション

治療

  • 照会パターン
  • 新たに診断されたステージI
  • 新たに診断されたステージIIまたはステージIII
  • 新たに診断されたステージIV
  • 薬理学的治療:ファーストライン
  • 薬理学的治療:再発/再発した疾患

疫学

  • 発生調査方法

市販薬

パイプライン薬

主な規制イベント

  • ImmunoGenが FORWARD撤退後、再編成し、新しい卵巣癌のフェーズIIIを検討

成功の確率

臨床試験の情勢

  • ステータス別スポンサー
  • フェーズ別スポンサー
  • 最新の事例

薬物評価モデル

市場力学

今後の動向

  • 新たな標的療法の発売とラベルの拡大により、予測期間中の卵巣癌市場の成長が促進される
  • バイオマーカーの状態は治療の決定においてますます重要になる
  • PARP阻害剤は、卵巣癌内の主要な薬物クラスであり続ける
  • ファーストラインとファーストラインのメンテナンス設定におけるPD-1 / PD-L1阻害剤間の競合は激化する

最新事例とアナリストの見解

  • 卵巣癌に対する複数の薬剤(2020年3月12日)
  • 卵巣癌に対するアセラリン(2020年3月10日)
  • 卵巣癌に対するDPX-Survivac(2020年2月25日)
  • 卵巣癌に対するファレツズマブ(2020年1月31日)
  • 卵巣癌に対するペギロデカキン(2020年1月30日)
  • 卵巣癌のオプジーボ(2020年1月24日)
  • 卵巣癌に対するAVB-500(2019年11月20日)
  • 卵巣癌に対するミルベツキシマブソラブタンシン(2019年9月29日)
  • 卵巣癌のゼジュラ(2019年9月28日)
  • 卵巣癌のベリパリブ(2019年9月28日)
  • 卵巣癌のリンパルザ(2019年9月28日)
  • 卵巣癌に対するAVB-500(2019年9月27日)
  • 卵巣癌に対するM6620(2019年9月27日)
  • 卵巣癌のリンパルザ(2019年8月14日)
  • Mavorixafor卵巣癌(2019年7月17日)
  • 卵巣癌のゼジュラ(2019年7月15日)
  • 卵巣癌に対するマグロリマブ(2019年7月11日)
  • 卵巣癌のMvasi(2019年6月25日)
  • 卵巣癌のリンパルザ(2019年6月3日)
  • 卵巣癌に対するXMT-1536(2019年6月1日)
  • 卵巣癌のチボパス(腫瘍学)(2019年6月1日)
  • 卵巣癌に対するミルベツキシマブソラブタンシン(2019年5月15日)
  • 卵巣癌に対するミルベツキシマブソラブタンシン(2019年5月15日)
  • 卵巣癌のルブラカ(2019年5月2日)
  • 卵巣癌のオプチューン(2019年3月22日)
  • 卵巣癌のDCVAC / OvCa(2019年3月19日)
  • 卵巣癌に対する複数の薬(2019年3月19日)
  • 卵巣癌に対するDKN-01(2019年3月18日)

コンセンサス予測

主な今後のイベント

主なオピニオンリーダーの考察

アンメットニーズ

  • プラチナ耐性/難治性卵巣癌の治療
  • 早期検出のためのテストの改善

参考文献

  • 処方箋情報

付録

図表

LIST OF FIGURES

  • Figure 1: Trends in incident cases of ovarian cancer, 2018-27
  • Figure 2: Overview of pipeline drugs for ovarian cancer in the US
  • Figure 3: Pipeline drugs for ovarian cancer, by company
  • Figure 4: Pipeline drugs for ovarian cancer, by drug type
  • Figure 5: Pipeline drugs for ovarian cancer, by classification
  • Figure 6: Probability of success in the ovarian cancer pipeline
  • Figure 7: Clinical trials in ovarian cancer
  • Figure 8: Top 10 drugs for clinical trials in ovarian cancer
  • Figure 9: Top 10 companies for clinical trials in ovarian cancer
  • Figure 10: Trial locations in ovarian cancer
  • Figure 11: Ovarian cancer trials status
  • Figure 12: Ovarian cancer trials sponsors, by phase
  • Figure 13: Datamonitor Healthcare's drug assessment summary for ovarian cancer
  • Figure 14: Market dynamics in ovarian cancer
  • Figure 15: Future trends in ovarian cancer
  • Figure 16: Lynparza and Recentin for Ovarian Cancer (March 12, 2020): Phase III - GY004 (w/Cediranib)
  • Figure 17: Acelarin for Ovarian Cancer (March 10, 2020): Phase II - PRO105
  • Figure 18: DPX-Survivac for Ovarian Cancer (February 25, 2020): Phase Ib/II - DeCidE1
  • Figure 19: Opdivo for Ovarian Cancer (January 24, 2020): Phase III - ONO-4538-23
  • Figure 20: Mirvetuximab Soravtansine for Ovarian Cancer (September 29, 2019): Phase III - FORWARD I
  • Figure 21: Zejula for Ovarian Cancer (September 28, 2019): Phase III - PRIMA
  • Figure 22: Zejula for Ovarian Cancer (September 28, 2019): Phase III - PRIMA
  • Figure 23: Veliparib for Ovarian Cancer (September 28, 2019): Phase III - VELIA (w/Carboplatin/paclitaxel)
  • Figure 24: Lynparza for Ovarian Cancer (September 28, 2019): Phase III - PAOLA-1
  • Figure 25: M6620 for Ovarian Cancer (September 27, 2019): Phase II - w/Gemcitabine
  • Figure 26: Lynparza for Ovarian Cancer (August 14, 2019): Phase III - PAOLA-1
  • Figure 27: Zejula for Ovarian Cancer (July 15, 2019): Phase III - PRIMA
  • Figure 28: Lynparza for Ovarian Cancer (June 3, 2019): Phase III - SOLO 3 (BRCA Mutation; Relapsed) - vs. Chemotherapy
  • Figure 29: XMT-1536 for Ovarian Cancer (June 1, 2019): Phase Ib - First-in-Human (NaPi2b)
  • Figure 30: Tivopath (Oncology) for Ovarian Cancer (June 1, 2019): Phase II - TIVO (Ovarian Cancer)
  • Figure 31: Mirvetuximab Soravtansine for Ovarian Cancer (May 15, 2019): Phase Ib/II - FORWARD II
  • Figure 32: DCVAC/OvCa for Ovarian Cancer (March 19, 2019): Phase II - SOV02 (Carboplatin and Gemcitabine)
  • Figure 33: DKN-01 for Ovarian Cancer (March 18, 2019): Phase II - Gynecologic Malignancies (P204)
  • Figure 34: Key upcoming events in ovarian cancer (Figure 1 of 2)
  • Figure 35: Key upcoming events in ovarian cancer (Figure 2 of 2)

LIST OF TABLES

  • Table 1: Patient segmentation, by FIGO stage
  • Table 2: Incident cases of ovarian cancer, 2018-27
  • Table 3: Marketed drugs for ovarian cancer
  • Table 4: Pipeline drugs for ovarian cancer
  • Table 5: Multiple Drugs for Ovarian Cancer (March 12, 2020)
  • Table 6: Acelarin for Ovarian Cancer (March 10, 2020)
  • Table 7: DPX-Survivac for Ovarian Cancer (February 25, 2020)
  • Table 8: Farletuzumab for Ovarian Cancer (January 31, 2020)
  • Table 9: Pegilodecakin for Ovarian Cancer (January 30, 2020)
  • Table 10: Opdivo for Ovarian Cancer (January 24, 2020)
  • Table 11: AVB-500 for Ovarian Cancer (November 20, 2019)
  • Table 12: Mirvetuximab Soravtansine for Ovarian Cancer (September 29, 2019)
  • Table 13: Zejula for Ovarian Cancer (September 28, 2019)
  • Table 14: Veliparib for Ovarian Cancer (September 28, 2019)
  • Table 15: Lynparza for Ovarian Cancer (September 28, 2019)
  • Table 16: AVB-500 for Ovarian Cancer (September 27, 2019)
  • Table 17: M6620 for Ovarian Cancer (September 27, 2019)
  • Table 18: Lynparza for Ovarian Cancer (August 14, 2019)
  • Table 19: Mavorixafor for Ovarian Cancer (July 17, 2019)
  • Table 20: Zejula for Ovarian Cancer (July 15, 2019)
  • Table 21: Magrolimab for Ovarian Cancer (July 11, 2019)
  • Table 22: Mvasi for Ovarian Cancer (June 25, 2019)
  • Table 23: Lynparza for Ovarian Cancer (June 3, 2019)
  • Table 24: XMT-1536 for Ovarian Cancer (June 1, 2019)
  • Table 25: Tivopath (Oncology) for Ovarian Cancer (June 1, 2019)
  • Table 26: Mirvetuximab Soravtansine for Ovarian Cancer (May 15, 2019)
  • Table 27: Mirvetuximab Soravtansine for Ovarian Cancer (May 15, 2019)
  • Table 28: Rubraca for Ovarian Cancer (May 2, 2019)
  • Table 29: Optune for Ovarian Cancer (March 22, 2019)
  • Table 30: DCVAC/OvCa for Ovarian Cancer (March 19, 2019)
  • Table 31: Multiple Drugs for Ovarian Cancer (March 19, 2019)
  • Table 32: DKN-01 for Ovarian Cancer (March 18, 2019)
  • Table 33: Historical global sales, by drug ($m), 2014-18
  • Table 34: Forecasted global sales, by drug ($m), 2020-24
目次
Product Code: DMKC0215129

Latest key takeaways

Datamonitor Healthcare estimates that in 2018, there were 293,300 incident cases of ovarian cancer worldwide in females aged 15 years and older, and forecasts that number to increase to 319,500 cases by 2027. Highly genericized platinum-containing chemotherapies are still the standard of care for both newly diagnosed and recurrent platinum-sensitive ovarian cancer patients.

The overall likelihood of approval of a Phase I ovarian cancer asset is 4.4%, and the average probability a drug advances from Phase III is 27.3%. Ovarian cancer drugs, on average, take 10.5 years from Phase I to approval, compared to 9.3 years in the overall oncology space.

Avastin has become the drug of choice for the maintenance treatment of ovarian cancer patients who do not have a BRCA mutation. However, upcoming patent expiries and expected competition from label expansions for the poly (ADP-ribose) polymerase (PARP) inhibitors and late-phase pipeline drugs will challenge Avastin's position in the ovarian cancer market.

The PARP inhibitor Lynparza has quickly become the standard of care first-line maintenance therapy for patients with BRCA mutated ovarian cancer in the US and EU. However, the PARP inhibitors Zejula and veliparib will soon compete with Lynparza in this treatment setting. Although all three PARP inhibitors have also demonstrated an advantage over chemotherapy in patients without a BRCA mutation or a homologous recombination deficiency (HRD), the primary benefit was derived in patients with BRCA or other HRD mutations, which may limit uptake in the broader patient population.

Rubraca, another PARP inhibitor, has experienced only moderate uptake in the US and the EU as a maintenance treatment for recurrent platinum-sensitive ovarian cancer, and in the US as a third-line or later treatment for BRCA mutation-positive (BRCAm+) patients. However, a potential combination with Opdivo in the first-line maintenance setting may expand Rubraca's commercial potential.

New product launches will play a pivotal part in future market dynamics over the next decade. Key new product launches will include checkpoint inhibitors, folate receptor alpha (FRα)-directed antibody-drug conjugate mirvetuximab soravtansine, the targeted anti-cancer viral-based gene therapy agent ofranergene obadenovec, and the VEGF inhibitor Recentin.

The inclusion of PARP inhibitors in the treatment paradigm has led to a subsequent increase in testing for germline and somatic BRCA1/2 mutations as well as genomic instability score (GIS). This trend of using biomarkers to inform treatment decisions will continue with the introduction of checkpoint inhibitors and mirvetuximab soravtansine, which will likely require PD-L1 and FRα testing, respectively.

Several PD-1/PD-L1 inhibitors - dostarlimab, Opdivo, Keytruda, Tecentriq, and Imfinzi - are in late-phase development in combination with carboplatin and paclitaxel with or without concurrent bevacizumab in the front-line and first-line maintenance setting. Because of the likely clinical similarities between drugs within this class, companies developing checkpoint inhibitors will seek to use label expansions into other treatment settings, such as the recurrent setting, to differentiate their products and increase the size of the potential patient population.

As platinum resistance continues to be the primary contributor to mortality in ovarian cancer patients, effective treatments for platinum-resistant or platinum-refractory ovarian cancer remain the largest unmet need within the indication. Treatment for platinum-resistant/refractory ovarian cancer is largely palliative and patients currently have very limited treatment options.

There are no routine screening methods recommended by medical or professional organizations because screening techniques using single tests or combined algorithms have not been shown to reduce all-cause or disease-specific morbidity or mortality. Research to address this unmet need through the development of reliable screening and diagnostic tools that detect early-stage ovarian cancer is ongoing.

Key recent events include Opdivo's Phase III failure as a monotherapy treatment for platinum-refractory recurrent ovarian cancer in ONO-4538-23, and a positive subgroup analysis for mirvetuximab soravtansine in the Phase III FORWARD I study.

Key upcoming catalysts for 2020 include topline results for the Phase III IMagyn050 study of Tecentriq and Avastin, the Phase III OVAL study of ofranergene obadenovec and paclitaxel, and the pivotal Phase II CONCERTO study of Recentin and Lynparza.

TABLE OF CONTENTS

OVERVIEW

  • Latest key takeaways

DISEASE BACKGROUND

  • Definition
  • Prognosis
  • Risk factors
  • Symptoms
  • Diagnosis
  • Patient segmentation

TREATMENT

  • Referral patterns
  • Newly diagnosed Stage I
  • Newly diagnosed Stage II or Stage III
  • Newly diagnosed Stage IV
  • Pharmacological treatment: first-line
  • Pharmacological treatment: recurrent/relapsed disease

EPIDEMIOLOGY

  • Incidence methodology

MARKETED DRUGS

PIPELINE DRUGS

KEY REGULATORY EVENTS

  • ImmunoGen Regroups After FORWARD Setback, Looks To New Ovarian Cancer Phase III

PROBABILITY OF SUCCESS

CLINICAL TRIAL LANDSCAPE

  • Sponsors by status
  • Sponsors by phase
  • Recent events

DRUG ASSESSMENT MODEL

MARKET DYNAMICS

FUTURE TRENDS

  • Launches of new targeted therapies and label expansions will drive growth in the ovarian cancer market over the forecast period
  • Biomarker status will become increasingly important in treatment decisions
  • PARP inhibitors will remain the leading drug class within ovarian cancer
  • Competition will be fierce between PD-1/PD-L1 inhibitors in the first-line and first-line maintenance settings

RECENT EVENTS AND ANALYST OPINION

  • Multiple Drugs for Ovarian Cancer (March 12, 2020)
  • Acelarin for Ovarian Cancer (March 10, 2020)
  • DPX-Survivac for Ovarian Cancer (February 25, 2020)
  • Farletuzumab for Ovarian Cancer (January 31, 2020)
  • Pegilodecakin for Ovarian Cancer (January 30, 2020)
  • Opdivo for Ovarian Cancer (January 24, 2020)
  • AVB-500 for Ovarian Cancer (November 20, 2019)
  • Mirvetuximab Soravtansine for Ovarian Cancer (September 29, 2019)
  • Zejula for Ovarian Cancer (September 28, 2019)
  • Veliparib for Ovarian Cancer (September 28, 2019)
  • Lynparza for Ovarian Cancer (September 28, 2019)
  • AVB-500 for Ovarian Cancer (September 27, 2019)
  • M6620 for Ovarian Cancer (September 27, 2019)
  • Lynparza for Ovarian Cancer (August 14, 2019)
  • Mavorixafor for Ovarian Cancer (July 17, 2019)
  • Zejula for Ovarian Cancer (July 15, 2019)
  • Magrolimab for Ovarian Cancer (July 11, 2019)
  • Mvasi for Ovarian Cancer (June 25, 2019)
  • Lynparza for Ovarian Cancer (June 3, 2019)
  • XMT-1536 for Ovarian Cancer (June 1, 2019)
  • Tivopath (Oncology) for Ovarian Cancer (June 1, 2019)
  • Mirvetuximab Soravtansine for Ovarian Cancer (May 15, 2019)
  • Mirvetuximab Soravtansine for Ovarian Cancer (May 15, 2019)
  • Rubraca for Ovarian Cancer (May 2, 2019)
  • Optune for Ovarian Cancer (March 22, 2019)
  • DCVAC/OvCa for Ovarian Cancer (March 19, 2019)
  • Multiple Drugs for Ovarian Cancer (March 19, 2019)
  • DKN-01 for Ovarian Cancer (March 18, 2019)

CONSENSUS FORECASTS

KEY UPCOMING EVENTS

KEY OPINION LEADER INSIGHTS

UNMET NEEDS

  • Treating platinum-resistant/refractory ovarian cancer
  • Improved testing for earlier detection

BIBLIOGRAPHY

  • Prescription information

APPENDIX