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질환 분석 : 난소암

Disease Analysis: Ovarian Cancer

리서치사 Datamonitor Healthcare
발행일 2021년 05월 상품코드 973518
페이지 정보 영문 83 Pages 배송안내 1-2일 (영업일 기준)
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질환 분석 : 난소암 Disease Analysis: Ovarian Cancer
발행일 : 2021년 05월 페이지 정보 : 영문 83 Pages

본 상품은 영문 자료로 한글과 영문 목차에 불일치하는 내용이 있을 경우 영문을 우선합니다. 정확한 검토를 위해 영문목차를 참고해주시기 바랍니다.

세계의 15세 이상 여성 난소암 발증건수는 2018년에 293,300건에 달하고, 2027년까지 293,300건으로 증가할 것으로 예측됩니다. 현재는 플라티나 함유 화학요법이 신규·재발 환자에 대한 표준적인 치료제가 되고 있지만, 기타 치료제의 임상시험도 현재 정력적으로 행해지고 있습니다.

세계의 난소암(Ovarian Cancer)용 치료제 임상시험 상황과 시장 동향 전망에 대해 분석했으며, 질환 개요와 역학 예측, 현재 주요 치료제(출시된/파이프라인 제품)과 임상시험 진행 상황, 현재 미충족 수요와 향후 시장 기회, 임상시험/시장 전망에 관한 전문가의 견해 등의 정보를 정리하여 전해드립니다.

목차

목차 내용

개요

질환 배경

  • 정의
  • 예후
  • 위험인자
  • 증상
  • 진단 방법
  • 환자 분류

치료 방법

  • 소개 패턴
  • 새롭게 진단된 스테이지 I 환자
  • 새롭게 진단된 스테이지 II/스테이지 III 환자
  • 새롭게 진단된 스테이지 IV 환자
  • 약리학적 치료 : first-line
  • 약리학적 치료 : 재발/재발성 질환

역학

  • 발증률 조사 방법

출시 의약품

파이프라인 의약품

규제상 주요 발전

  • Takeda : Zejula로의 조기 액세스
  • Lynparza : 진행성 난소암의 EU 권고
  • Lynparza : 1차 난소암 유지로 확대
  • GSK : Zejula가 1차 난소암 사용을 차지

성공 가능성

라이선싱/자산 인수 거래

  • Epsilogen : King's College London으로부터 잠재적 난소암 항체를 라이선싱

임상시험 상황

  • 임상시험 의뢰자 분류 : 상황별
  • 임상시험 의뢰자 분류 : 상(단계)별
  • 최근의 동향

의약품 평가 모델

시장 역학

향후 동향

  • 새로운 표적요법 개시와 라벨 확대 : 향후 난소암 시장 성장 촉진
  • 바이오마커 상태 : 치료 결정에서의 중요도 증대
  • PARP 억제제 : 향후에도 난소암의 주요 약제 클래스가 된다
  • first-line과 first-line 유지관리 설정에서 PD-1/PD-L1 억제제간 경쟁 격화

컨센서스 예측

최근의 사건과 애널리스트의 의견

  • 난소암용 Tecentriq(2020년 9월 21일)
  • 난소암용 Olvi-Vec(2020년 9월 10일)
  • 난소암용 다양한 약(2020년 7월 12일)
  • 난소암용 Zejula(2020년 5월 31일)
  • 난소암용 Lynparza(2020년 5월 29일)
  • 난소암용 Mirvetuximab Soravtansine(2020년 5월 29일)
  • 난소암용 다양한 약(2020년 5월 29일)
  • 난소암용 Recentin(2020년 5월 29일)
  • 난소암용 VigilEATC(2020년 5월 13일)
  • 난소암용 VB-111(2020년 3월 26일)
  • 난소암용 다양한 약(2020년 3월 12일)
  • 난소암용 Acelarin(2020년 3월 10일)
  • 난소암용 DPX-Survivac(2020년 2월 25일)
  • 난소암용 Farletuzumab(2020년 1월 31일)
  • 난소암용 Pegilodecakin(2020년 1월 30일)
  • 난소암용 Opdivo(2020년 1월 24일)
  • 난소암용 AVB-500(2019년 11월 20일)

향후 시장의 주요 발전

KOL(전문가)의 견해

미충족 수요

  • 플라티나 내성/난치성 난소암 치료
  • 조기 발견을 위한 개선된 테스트

참고문헌

  • 처방약 정보

부록

KSM 20.12.15

Definition:

Ovarian cancer is defined as a group of tumors that originate in the ovaries. Most ovarian cancers are epithelial carcinomas which begin in the tissue surrounding the ovary. Other less common types of ovarian tumors include primary peritoneal, fallopian tube, and malignant germ cell tumors. Ovarian cancer is the fourth most common cancer among women, and is the leading cause of gynecological cancer-related death in women.

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 2.7%, and the average probability a drug advances from Phase III is 24%. Ovarian cancer drugs, on average, take 10.7 years from Phase I to approval, compared to 9.6 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 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. However, fellow PARP inhibitor Zejula is now challenging Lynparza in this treatment setting. A third PARP inhibitor, veliparib, is expected to compete with both Lynparza and Zejula. 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 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, and the targeted anti-cancer viral-based gene therapy agent ofranergene obadenovec.

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 - Jemperli, Opdivo, Keytruda, 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 settings. 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 to 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 Zejula's approval across therapy lines in Japan, a supplemental approval in the EU for Zejula as a monotherapy first-line maintenance treatment, and Tecentriq's Phase III failure for newly diagnosed advanced ovarian cancer in IMagyn050.

TABLE OF CONTENTS

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

  • Biocon And Viatris Ready To Launch EU Bevacizumab
  • Stada-Mabxience Bevacizumab Is Latest To Receive EU Nod
  • Mystery Surrounds Second Samsung Bioepis Avastin Biosimilar
  • Early Access To Takeda's Zejula
  • Lynparza EU Recommendation In Advanced Ovarian Cancer
  • Lynparza Expands In First-Line Ovarian Cancer Maintenance

PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS

  • Kazia Therapeutics Licenses Cantrixil To Oasmia Pharmaceutical
  • Merck & Co To Evaluate Starpharma Dendrimer Delivery Tech For ADCs
  • Elevar Licenses EU Rights For Apealea To Inceptua
  • CStone Gets Global Rights, Except South Korea, To LegoChem Candidate
  • Epsilogen Licenses Potential Ovarian Cancer Antibody From King's College London

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

CONSENSUS FORECASTS

RECENT EVENTS AND ANALYST OPINION

  • Relacorilant for Ovarian Cancer (May 7, 2021)
  • Farletuzumab for Ovarian Cancer (March 21, 2021)
  • STRO-002 for Ovarian Cancer (December 3, 2020)
  • Vigil EATC for Ovarian Cancer (December 1, 2020)
  • Tecentriq for Ovarian Cancer (September 21, 2020)
  • Olvi-Vec for Ovarian Cancer (September 10, 2020)
  • Multiple Drugs for Ovarian Cancer (July 12, 2020)
  • Zejula for Ovarian Cancer (May 31, 2020)
  • Lynparza for Ovarian Cancer (May 29, 2020)
  • Mirvetuximab Soravtansine for Ovarian Cancer (May 29, 2020)
  • Multiple Drugs for Ovarian Cancer (May 29, 2020)
  • Recentin for Ovarian Cancer (May 29, 2020)
  • Vigil EATC for Ovarian Cancer (May 13, 2020)

KEY UPCOMING EVENTS

KEY OPINION LEADER INSIGHTS

UNMET NEEDS

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

BIBLIOGRAPHY

APPENDIX

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: Relacorilant for Ovarian Cancer (May 7, 2021): Phase II - w/Nab-Paclitaxel
  • Figure 17: Farletuzumab for Ovarian Cancer (March 21, 2021): Phase II - w/Chemotherapy (Study 011, Platinum Sensitive)
  • Figure 18: Vigil EATC for Ovarian Cancer (December 1, 2020): Phase IIb - VITAL
  • Figure 19: Tecentriq for Ovarian Cancer (September 21, 2020): Phase III - IMagyn050 (w/Avastin, Newly-Diagnosed)
  • Figure 20: Olvi-Vec for Ovarian Cancer (September 10, 2020): Phase Ib/II - VIRO-15
  • Figure 21: Tecentriq and Avastin for Ovarian Cancer (July 12, 2020)
  • Figure 22: Lynparza for Ovarian Cancer (May 29, 2020): Phase III - SOLO 2 (BRCA Mutation; Relapsed)
  • Figure 23: Mirvetuximab Soravtansine for Ovarian Cancer (May 29, 2020): Phase Ib/II - FORWARD II
  • Figure 24: Lynparza and Recentin for Ovarian Cancer (May 29, 2020)
  • Figure 25: Vigil EATC for Ovarian Cancer (May 13, 2020): Phase II - w/Tecentriq
  • Figure 26: Key upcoming events in ovarian cancer

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 in the US
  • Table 5: Historical global sales, by drug ($m), 2016-20
  • Table 6: Forecasted global sales, by drug ($m), 2021-25
  • Table 7: Relacorilant for Ovarian Cancer (May 7, 2021)
  • Table 8: Farletuzumab for Ovarian Cancer (March 21, 2021)
  • Table 9: STRO-002 for Ovarian Cancer (December 3, 2020)
  • Table 10: Vigil EATC for Ovarian Cancer (December 1, 2020)
  • Table 11: Tecentriq for Ovarian Cancer (September 21, 2020)
  • Table 12: Olvi-Vec for Ovarian Cancer (September 10, 2020)
  • Table 13: Multiple Drugs for Ovarian Cancer (July 12, 2020)
  • Table 14: Zejula for Ovarian Cancer (May 31, 2020)
  • Table 15: Lynparza for Ovarian Cancer (May 29, 2020)
  • Table 16: Mirvetuximab Soravtansine for Ovarian Cancer (May 29, 2020)
  • Table 17: Multiple Drugs for Ovarian Cancer (May 29, 2020)
  • Table 18: Recentin for Ovarian Cancer (May 29, 2020)
  • Table 19: Vigil EATC for Ovarian Cancer (May 13, 2020)
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