Disease Analysis: Ovarian Cancer
Author: Tara Hansen
Publisher: Datamonitor Healthcare
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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.
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 Biocon And Viatris Ready To Launch EU Bevacizumab
39 Stada-Mabxience Bevacizumab Is Latest To Receive EU Nod
39 Mystery Surrounds Second Samsung Bioepis Avastin Biosimilar
39 Early Access To Takeda’s Zejula
40 Lynparza EU Recommendation In Advanced Ovarian Cancer
40 Lynparza Expands In First-Line Ovarian Cancer Maintenance
41 PROBABILITY OF SUCCESS
42 LICENSING AND ASSET ACQUISITION DEALS
42 Kazia Therapeutics Licenses Cantrixil To Oasmia Pharmaceutical
42 Merck & Co To Evaluate Starpharma Dendrimer Delivery Tech For ADCs
42 Elevar Licenses EU Rights For Apealea To Inceptua
42 CStone Gets Global Rights, Except South Korea, To LegoChem Candidate
43 Epsilogen Licenses Potential Ovarian Cancer Antibody From King’s College London
44 CLINICAL TRIAL LANDSCAPE
45 Sponsors by status
46 Sponsors by phase
47 Recent events
50 DRUG ASSESSMENT MODEL
53 MARKET DYNAMICS
54 FUTURE TRENDS
54 Launches of new targeted therapies and label expansions will drive growth in the ovarian cancer market over the forecast period
54 Biomarker status will become increasingly important in treatment decisions
54 PARP inhibitors will remain the leading drug class within ovarian cancer
55 Competition will be fierce between PD-1/PD-L1 inhibitors in the first-line and first-line maintenance settings
56 CONSENSUS FORECASTS
58 RECENT EVENTS AND ANALYST OPINION
58 Relacorilant for Ovarian Cancer (May 7, 2021)
59 Farletuzumab for Ovarian Cancer (March 21, 2021)
60 STRO-002 for Ovarian Cancer (December 3, 2020)
61 Vigil EATC for Ovarian Cancer (December 1, 2020)
63 Tecentriq for Ovarian Cancer (September 21, 2020)
64 Olvi-Vec for Ovarian Cancer (September 10, 2020)
66 Multiple Drugs for Ovarian Cancer (July 12, 2020)
68 Zejula for Ovarian Cancer (May 31, 2020)
69 Lynparza for Ovarian Cancer (May 29, 2020)
70 Mirvetuximab Soravtansine for Ovarian Cancer (May 29, 2020)
72 Multiple Drugs for Ovarian Cancer (May 29, 2020)
73 Recentin for Ovarian Cancer (May 29, 2020)
74 Vigil EATC for Ovarian Cancer (May 13, 2020)
77 KEY UPCOMING EVENTS
78 KEY OPINION LEADER INSIGHTS
79 UNMET NEEDS
79 Treating platinum-resistant/refractory ovarian cancer
79 Improved testing for earlier detection
80 BIBLIOGRAPHY
82 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
41 Figure 6: Probability of success in the ovarian cancer pipeline
44 Figure 7: Clinical trials in ovarian cancer
44 Figure 8: Top 10 drugs for clinical trials in ovarian cancer
45 Figure 9: Top 10 companies for clinical trials in ovarian cancer
45 Figure 10: Trial locations in ovarian cancer
46 Figure 11: Ovarian cancer trials status
47 Figure 12: Ovarian cancer trials sponsors, by phase
50 Figure 13: Datamonitor Healthcare’s drug assessment summary for ovarian cancer
53 Figure 14: Market dynamics in ovarian cancer
54 Figure 15: Future trends in ovarian cancer
59 Figure 16: Relacorilant for Ovarian Cancer (May 7, 2021): Phase II – w/Nab-Paclitaxel
60 Figure 17: Farletuzumab for Ovarian Cancer (March 21, 2021): Phase II – w/Chemotherapy (Study 011, Platinum Sensitive)
63 Figure 18: Vigil EATC for Ovarian Cancer (December 1, 2020): Phase IIb – VITAL
64 Figure 19: Tecentriq for Ovarian Cancer (September 21, 2020): Phase III – IMagyn050 (w/Avastin, Newly-Diagnosed)
66 Figure 20: Olvi-Vec for Ovarian Cancer (September 10, 2020): Phase Ib/II – VIRO-15
68 Figure 21: Tecentriq and Avastin for Ovarian Cancer (July 12, 2020)
70 Figure 22: Lynparza for Ovarian Cancer (May 29, 2020): Phase III – SOLO 2 (BRCA Mutation; Relapsed)
72 Figure 23: Mirvetuximab Soravtansine for Ovarian Cancer (May 29, 2020): Phase Ib/II – FORWARD II
73 Figure 24: Lynparza and Recentin for Ovarian Cancer (May 29, 2020)
76 Figure 25: Vigil EATC for Ovarian Cancer (May 13, 2020): Phase II – w/Tecentriq
77 Figure 26: 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
56 Table 5: Historical global sales, by drug ($m), 2016–20
57 Table 6: Forecasted global sales, by drug ($m), 2021–25
58 Table 7: Relacorilant for Ovarian Cancer (May 7, 2021)
59 Table 8: Farletuzumab for Ovarian Cancer (March 21, 2021)
61 Table 9: STRO-002 for Ovarian Cancer (December 3, 2020)
62 Table 10: Vigil EATC for Ovarian Cancer (December 1, 2020)
63 Table 11: Tecentriq for Ovarian Cancer (September 21, 2020)
65 Table 12: Olvi-Vec for Ovarian Cancer (September 10, 2020)
67 Table 13: Multiple Drugs for Ovarian Cancer (July 12, 2020)
68 Table 14: Zejula for Ovarian Cancer (May 31, 2020)
69 Table 15: Lynparza for Ovarian Cancer (May 29, 2020)
71 Table 16: Mirvetuximab Soravtansine for Ovarian Cancer (May 29, 2020)
72 Table 17: Multiple Drugs for Ovarian Cancer (May 29, 2020)
74 Table 18: Recentin for Ovarian Cancer (May 29, 2020)
75 Table 19: Vigil EATC for Ovarian Cancer (May 13, 2020)
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