Disease Analysis: Ovarian Cancer
Author: Tara Hansen
Publisher: Datamonitor Healthcare
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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 4.1%, and the average probability a drug advances from Phase III is 27.3%. Ovarian cancer drugs, on average, take 10.6 years from Phase I to approval, compared to 9.4 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 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 – 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 a supplemental approval in the US for Zejula as a monotherapy first-line maintenance treatment, Tecentriq’s Phase III failure for newly diagnosed advanced ovarian cancer in IMagyn050, and Recentin’s failures in both the Phase IIb CONCERTO and Phase II GY004 studies.
CONTENTS
8 OVERVIEW
8 Latest key takeaways
10 DISEASE BACKGROUND
10 Definition
10 Prognosis
10 Risk factors
12 Symptoms
12 Diagnosis
13 Patient segmentation
15 TREATMENT
15 Referral patterns
15 Newly diagnosed Stage I
15 Newly diagnosed Stage II or Stage III
15 Newly diagnosed Stage IV
15 Pharmacological treatment: first-line
16 Pharmacological treatment: recurrent/relapsed disease
18 EPIDEMIOLOGY
18 Incidence methodology
21 MARKETED DRUGS
25 PIPELINE DRUGS
40 KEY REGULATORY EVENTS
40 CHMP Says Yes to Biosimilar Medicine Equidacent
40 Lynparza Expands In First-Line Ovarian Cancer Maintenance
40 GSK’s Zejula Wins First-Line Ovarian Cancer Use
41 PROBABILITY OF SUCCESS
42 LICENSING AND ASSET ACQUISITION DEALS
42 Epsilogen Licenses Potential Ovarian Cancer Antibody From King’s College London
43 CLINICAL TRIAL LANDSCAPE
44 Sponsors by status
45 Sponsors by phase
46 Recent events
49 DRUG ASSESSMENT MODEL
52 MARKET DYNAMICS
53 FUTURE TRENDS
53 Launches of new targeted therapies and label expansions will drive growth in the ovarian cancer market over the forecast period
53 Biomarker status will become increasingly important in treatment decisions
53 PARP inhibitors will remain the leading drug class within ovarian cancer
54 Competition will be fierce between PD-1/PD-L1 inhibitors in the first-line and first-line maintenance settings
55 CONSENSUS FORECASTS
57 RECENT EVENTS AND ANALYST OPINION
57 Multiple Drugs for Ovarian Cancer (July 12, 2020)
58 Zejula for Ovarian Cancer (May 31, 2020)
59 Lynparza for Ovarian Cancer (May 29, 2020)
60 Mirvetuximab Soravtansine for Ovarian Cancer (May 29, 2020)
62 Multiple Drugs for Ovarian Cancer (May 29, 2020)
63 Recentin for Ovarian Cancer (May 29, 2020)
64 Vigil EATC for Ovarian Cancer (May 13, 2020)
66 VB-111 for Ovarian Cancer (March 26, 2020)
67 Multiple Drugs for Ovarian Cancer (March 12, 2020)
68 Acelarin for Ovarian Cancer (March 10, 2020)
70 DPX-Survivac for Ovarian Cancer (February 25, 2020)
72 Farletuzumab for Ovarian Cancer (January 31, 2020)
73 Pegilodecakin for Ovarian Cancer (January 30, 2020)
73 Opdivo for Ovarian Cancer (January 24, 2020)
75 AVB-500 for Ovarian Cancer (November 20, 2019)
76 Mirvetuximab Soravtansine for Ovarian Cancer (September 29, 2019)
77 Lynparza for Ovarian Cancer (September 28, 2019)
79 Veliparib for Ovarian Cancer (September 28, 2019)
81 Zejula for Ovarian Cancer (September 28, 2019)
83 AVB-500 for Ovarian Cancer (September 27, 2019)
84 M6620 for Ovarian Cancer (September 27, 2019)
86 Lynparza for Ovarian Cancer (August 14, 2019)
88 KEY UPCOMING EVENTS
89 KEY OPINION LEADER INSIGHTS
90 UNMET NEEDS
90 Treating platinum-resistant/refractory ovarian cancer
90 Improved testing for earlier detection
91 BIBLIOGRAPHY
92 Prescription information
94 APPENDIX
LIST OF FIGURES
20 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
43 Figure 7: Clinical trials in ovarian cancer
43 Figure 8: Top 10 drugs for clinical trials in ovarian cancer
44 Figure 9: Top 10 companies for clinical trials in ovarian cancer
44 Figure 10: Trial locations in ovarian cancer
45 Figure 11: Ovarian cancer trials status
46 Figure 12: Ovarian cancer trials sponsors, by phase
49 Figure 13: Datamonitor Healthcare’s drug assessment summary for ovarian cancer
52 Figure 14: Market dynamics in ovarian cancer
53 Figure 15: Future trends in ovarian cancer
58 Figure 16: Tecentriq and Avastin for Ovarian Cancer (July 12, 2020)
60 Figure 17: Lynparza for Ovarian Cancer (May 29, 2020): Phase III – SOLO 2 (BRCA Mutation; Relapsed)
62 Figure 18: Mirvetuximab Soravtansine for Ovarian Cancer (May 29, 2020): Phase Ib/II – FORWARD II
63 Figure 19: Lynparza and Recentin for Ovarian Cancer (May 29, 2020)
66 Figure 20: Vigil EATC for Ovarian Cancer (May 13, 2020): Phase II – w/Tecentriq
68 Figure 21: Lynparza and Recentin for Ovarian Cancer (March 12, 2020)
70 Figure 22: Acelarin for Ovarian Cancer (March 10, 2020): Phase II – PRO105
72 Figure 23: DPX-Survivac for Ovarian Cancer (February 25, 2020): Phase Ib/II – DeCidE1
75 Figure 24: Opdivo for Ovarian Cancer (January 24, 2020): Phase III – ONO-4538-23
77 Figure 25: Mirvetuximab Soravtansine for Ovarian Cancer (September 29, 2019): Phase III – FORWARD I
79 Figure 26: Lynparza for Ovarian Cancer (September 28, 2019): Phase III – PAOLA-1
81 Figure 27: Veliparib for Ovarian Cancer (September 28, 2019): Phase III – VELIA (w/Carboplatin/paclitaxel)
83 Figure 28: Zejula for Ovarian Cancer (September 28, 2019): Phase III – PRIMA
83 Figure 29: Zejula for Ovarian Cancer (September 28, 2019): Phase III – PRIMA
86 Figure 30: M6620 for Ovarian Cancer (September 27, 2019): Phase II – w/Gemcitabine
87 Figure 31: Lynparza for Ovarian Cancer (August 14, 2019): Phase III – PAOLA-1
88 Figure 32: Key upcoming events in ovarian cancer (Figure 1 of 2)
88 Figure 33: Key upcoming events in ovarian cancer (Figure 2 of 2)
LIST OF TABLES
14 Table 1: Patient segmentation, by FIGO stage
19 Table 2: Incident cases of ovarian cancer, 2018–27
22 Table 3: Marketed drugs for ovarian cancer
27 Table 4: Pipeline drugs for ovarian cancer
55 Table 5: Historical global sales, by drug ($m), 2015–19
56 Table 6: Forecasted global sales, by drug ($m), 2020–24
57 Table 7: Multiple Drugs for Ovarian Cancer (July 12, 2020)
58 Table 8: Zejula for Ovarian Cancer (May 31, 2020)
59 Table 9: Lynparza for Ovarian Cancer (May 29, 2020)
61 Table 10: Mirvetuximab Soravtansine for Ovarian Cancer (May 29, 2020)
62 Table 11: Multiple Drugs for Ovarian Cancer (May 29, 2020)
64 Table 12: Recentin for Ovarian Cancer (May 29, 2020)
65 Table 13: Vigil EATC for Ovarian Cancer (May 13, 2020)
66 Table 14: VB-111 for Ovarian Cancer (March 26, 2020)
67 Table 15: Multiple Drugs for Ovarian Cancer (March 12, 2020)
69 Table 16: Acelarin for Ovarian Cancer (March 10, 2020)
71 Table 17: DPX-Survivac for Ovarian Cancer (February 25, 2020)
72 Table 18: Farletuzumab for Ovarian Cancer (January 31, 2020)
73 Table 19: Pegilodecakin for Ovarian Cancer (January 30, 2020)
74 Table 20: Opdivo for Ovarian Cancer (January 24, 2020)
75 Table 21: AVB-500 for Ovarian Cancer (November 20, 2019)
76 Table 22: Mirvetuximab Soravtansine for Ovarian Cancer (September 29, 2019)
78 Table 23: Lynparza for Ovarian Cancer (September 28, 2019)
79 Table 24: Veliparib for Ovarian Cancer (September 28, 2019)
82 Table 25: Zejula for Ovarian Cancer (September 28, 2019)
84 Table 26: AVB-500 for Ovarian Cancer (September 27, 2019)
85 Table 27: M6620 for Ovarian Cancer (September 27, 2019)
86 Table 28: Lynparza for Ovarian Cancer (August 14, 2019)
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