Disease Analysis: Ovarian Cancer
Author: Ellie Davenport
Publisher: Datamonitor Healthcare
- Description
- Contents
- Enquire
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 2021, there were 302,100 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 2.9%, and the average probability a drug advances from Phase III is 25.0%. Ovarian cancer drugs, on average, take 10.9 years from Phase I to approval, compared to 9.7 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 anticancer viral-based gene therapy agent Ofra-Vec.
- 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.
- 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 topline results for Rubraca in the Phase III ATHENA-MONO trial, and for mirvetuximab soravtansine in the Phase III SORAYA trial. Furthermore, a regulatory filing has been submitted for mirvetuximab soravtansine in the US.
- Key upcoming catalysts include topline Phase III results for AVB-500. Additionally, regulatory submissions are expected for Lynparza + cediranib in the second-line setting in the US, EU, and Japan, and for Rubraca as a first-line maintenance therapy in the US.
CONTENTS
7 OVERVIEW
7 Latest key takeaways
9 DISEASE BACKGROUND
9 Definition
9 Prognosis
9 Risk factors
11 Symptoms
11 Diagnosis
12 Patient segmentation
14 TREATMENT
14 Referral patterns
14 Newly diagnosed Stage I
14 Newly diagnosed Stage II or Stage III
14 Newly diagnosed Stage IV
14 Pharmacological treatment: first-line
15 Pharmacological treatment: recurrent/relapsed disease
17 EPIDEMIOLOGY
17 Incidence methodology
20 MARKETED DRUGS
25 PIPELINE DRUGS
39 KEY REGULATORY EVENTS
39 ImmunoGen Rests ADC Accelerated Approval Bid On SORAYA Trial
39 Accord Sees Two Hybrids Endorsed By EU’s CHMP
39 New Data Helps Darzalex & Zejula Switch To Routine Funding In England
40 On Target Aims To Light Up Ovarian Cancer Diagnosis
40 Apotex Begins Roll Out Of Avastin Biosimilar In Canada
40 Biocon And Viatris Ready To Launch EU Bevacizumab
42 PROBABILITY OF SUCCESS
43 LICENSING AND ASSET ACQUISITION DEALS
43 Tianjin Tasly Inks $40m Licensing Deal With Sutro For ADC Cancer Treatment
43 Mersana Therapeutics Expands ADC Development Partnership With Synaffix
43 QIAGEN Signs Agreement With OncXerna Therapeutics To Develop Companion Diagnostic
43 Genelux Collaborates With Newsoara Biopharma
44 Oasmia Signs Agreement With FarmaMondo To Commercialize Paclical In Russia and CIS
44 MS Pharma Partners With Mabxience For Bevacizumab In MENA Region
44 BMS, Eisai Team Up To Accelerate Development Of Solid-Tumor ADC
44 Laevoroc Oncology Gains Worldwide Patents For Oral Prodrug Of Gemcitabine
45 Mereo BioPharma Group Enters Partnership With Cancer Focus Fund
46 CLINICAL TRIAL LANDSCAPE
47 Sponsors by status
48 Sponsors by phase
49 Recent events
52 DRUG ASSESSMENT MODEL
56 MARKET DYNAMICS
57 FUTURE TRENDS
57 Launches of new targeted therapies and label expansions will drive growth in the ovarian cancer market over the forecast period
57 Biomarker status will become increasingly important in treatment decisions
57 PARP inhibitors will remain the leading drug class within ovarian cancer
58 Competition will be fierce between PD-1/PD-L1 inhibitors in the first-line and first-line maintenance settings
59 CONSENSUS FORECASTS
61 RECENT EVENTS AND ANALYST OPINION
61 Mirvetuximab Soravtansine for Ovarian Cancer (November 30, 2021)
62 Relacorilant for Ovarian Cancer (September 17, 2021)
64 DPX-Survivac for Ovarian Cancer (August 10, 2021)
66 Relacorilant for Ovarian Cancer (May 7, 2021)
68 Farletuzumab for Ovarian Cancer (March 21, 2021)
69 STRO-002 for Ovarian Cancer (December 3, 2020)
70 Vigil EATC for Ovarian Cancer (December 1, 2020)
73 KEY UPCOMING EVENTS
74 KEY OPINION LEADER INSIGHTS
75 UNMET NEEDS
75 Treating platinum-resistant/refractory ovarian cancer
75 Improved testing for earlier detection
76 BIBLIOGRAPHY
78 APPENDIX
LIST OF FIGURES
19 Figure 1: Trends in incident cases of ovarian cancer, 2018–27
25 Figure 2: Overview of pipeline drugs for ovarian cancer in the US
25 Figure 3: Pipeline drugs for ovarian cancer, by company
26 Figure 4: Pipeline drugs for ovarian cancer, by drug type
26 Figure 5: Pipeline drugs for ovarian cancer, by classification
42 Figure 6: Probability of success in the ovarian cancer pipeline
46 Figure 7: Clinical trials in ovarian cancer
46 Figure 8: Top 10 drugs for clinical trials in ovarian cancer
47 Figure 9: Top 10 companies for clinical trials in ovarian cancer
47 Figure 10: Trial locations in ovarian cancer
48 Figure 11: Ovarian cancer trials status
49 Figure 12: Ovarian cancer trials sponsors, by phase
52 Figure 13: Datamonitor Healthcare’s drug assessment summary for ovarian cancer
56 Figure 14: Market dynamics in ovarian cancer
57 Figure 15: Future trends in ovarian cancer
62 Figure 16: Mirvetuximab Soravtansine for Ovarian Cancer (November 30, 2021): Phase III – SORAYA
64 Figure 17: Relacorilant for Ovarian Cancer (September 17, 2021): Phase II – w/Nab-Paclitaxel
66 Figure 18: DPX-Survivac for Ovarian Cancer (August 10, 2021): Phase Ib/II – DeCidE1
68 Figure 19: Relacorilant for Ovarian Cancer (May 7, 2021): Phase II – w/Nab-Paclitaxel
69 Figure 20: Farletuzumab for Ovarian Cancer (March 21, 2021): Phase II – w/Chemotherapy (Study 011, Platinum Sensitive)
72 Figure 21: Vigil EATC for Ovarian Cancer (December 1, 2020): Phase IIb – VITAL
73 Figure 22: Key upcoming events in ovarian cancer
LIST OF TABLES
13 Table 1: Patient segmentation, by FIGO stage
18 Table 2: Incident cases of ovarian cancer, 2018–27
21 Table 3: Marketed drugs for ovarian cancer
27 Table 4: Pipeline drugs for ovarian cancer in the US
59 Table 5: Historical global sales, by drug ($m), 2017–21
60 Table 6: Forecasted global sales, by drug ($m), 2022–26
61 Table 7: Mirvetuximab Soravtansine for Ovarian Cancer (November 30, 2021)
63 Table 8: Relacorilant for Ovarian Cancer (September 17, 2021)
65 Table 9: DPX-Survivac for Ovarian Cancer (August 10, 2021)
67 Table 10: Relacorilant for Ovarian Cancer (May 7, 2021)
68 Table 11: Farletuzumab for Ovarian Cancer (March 21, 2021)
70 Table 12: STRO-002 for Ovarian Cancer (December 3, 2020)
71 Table 13: Vigil EATC for Ovarian Cancer (December 1, 2020)
© Informa UK Ltd. This document is a licensed product and is not to be reproduced or redistributed
Do you have a subscription to Datamonitor Healthcare, Biomedtracker or Meddevicetracker? You may already have access to these reports, contact your account manager or email pharma@informabi.com for further help or assistance.
Disease Analysis: Hepatocellular Carcinoma (HCC) 
Sign up to the