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 2.9%, and the average probability a drug advances from Phase III is 25%. 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 – dostarlimab, 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 Stada-Mabxience Bevacizumab Is Latest To Receive EU Nod
39 Mystery Surrounds Second Samsung Bioepis Avastin Biosimilar
39 Early Access To Takeda’s Zejula
39 Lynparza EU Recommendation In Advanced Ovarian Cancer
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 Elevar Licenses EU Rights For Apealea To Inceptua
42 CStone Gets Global Rights, Except South Korea, To LegoChem Candidate
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
48 DRUG ASSESSMENT MODEL
51 MARKET DYNAMICS
52 FUTURE TRENDS
52 Launches of new targeted therapies and label expansions will drive growth in the ovarian cancer market over the forecast period
52 Biomarker status will become increasingly important in treatment decisions
52 PARP inhibitors will remain the leading drug class within ovarian cancer
53 Competition will be fierce between PD-1/PD-L1 inhibitors in the first-line and first-line maintenance settings
54 CONSENSUS FORECASTS
56 RECENT EVENTS AND ANALYST OPINION
56 STRO-002 for Ovarian Cancer (December 3, 2020)
57 Vigil EATC for Ovarian Cancer (December 1, 2020)
58 Tecentriq for Ovarian Cancer (September 21, 2020)
59 Olvi-Vec for Ovarian Cancer (September 10, 2020)
61 Multiple Drugs for Ovarian Cancer (July 12, 2020)
63 Zejula for Ovarian Cancer (May 31, 2020)
64 Lynparza for Ovarian Cancer (May 29, 2020)
65 Mirvetuximab Soravtansine for Ovarian Cancer (May 29, 2020)
67 Multiple Drugs for Ovarian Cancer (May 29, 2020)
68 Recentin for Ovarian Cancer (May 29, 2020)
69 Vigil EATC for Ovarian Cancer (May 13, 2020)
71 VB-111 for Ovarian Cancer (March 26, 2020)
72 Multiple Drugs for Ovarian Cancer (March 12, 2020)
73 Acelarin for Ovarian Cancer (March 10, 2020)
75 DPX-Survivac for Ovarian Cancer (February 25, 2020)
78 KEY UPCOMING EVENTS
79 KEY OPINION LEADER INSIGHTS
80 UNMET NEEDS
80 Treating platinum-resistant/refractory ovarian cancer
80 Improved testing for earlier detection
81 BIBLIOGRAPHY
82 Prescription information
84 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
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
48 Figure 13: Datamonitor Healthcare’s drug assessment summary for ovarian cancer
51 Figure 14: Market dynamics in ovarian cancer
52 Figure 15: Future trends in ovarian cancer
58 Figure 16: Vigil EATC for Ovarian Cancer (December 1, 2020): Phase IIb – VITAL
59 Figure 17: Tecentriq for Ovarian Cancer (September 21, 2020): Phase III – IMagyn050 (w/Avastin, Newly-Diagnosed)
61 Figure 18: Olvi-Vec for Ovarian Cancer (September 10, 2020): Phase Ib/II – VIRO-15
63 Figure 19: Tecentriq and Avastin for Ovarian Cancer (July 12, 2020)
65 Figure 20: Lynparza for Ovarian Cancer (May 29, 2020): Phase III – SOLO 2 (BRCA Mutation; Relapsed)
67 Figure 21: Mirvetuximab Soravtansine for Ovarian Cancer (May 29, 2020): Phase Ib/II – FORWARD II
68 Figure 22: Lynparza and Recentin for Ovarian Cancer (May 29, 2020)
71 Figure 23: Vigil EATC for Ovarian Cancer (May 13, 2020): Phase II – w/Tecentriq
73 Figure 24: Lynparza and Recentin for Ovarian Cancer (March 12, 2020)
75 Figure 25: Acelarin for Ovarian Cancer (March 10, 2020): Phase II – PRO105
77 Figure 26: DPX-Survivac for Ovarian Cancer (February 25, 2020): Phase Ib/II – DeCidE1
78 Figure 27: Key upcoming events in ovarian cancer (Figure 1 of 2)
78 Figure 28: Key upcoming events in ovarian cancer (Figure 2 of 2)
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
54 Table 5: Historical global sales, by drug ($m), 2015–19
55 Table 6: Forecasted global sales, by drug ($m), 2021–25
56 Table 7: STRO-002 for Ovarian Cancer (December 3, 2020)
57 Table 8: Vigil EATC for Ovarian Cancer (December 1, 2020)
58 Table 9: Tecentriq for Ovarian Cancer (September 21, 2020)
60 Table 10: Olvi-Vec for Ovarian Cancer (September 10, 2020)
62 Table 11: Multiple Drugs for Ovarian Cancer (July 12, 2020)
63 Table 12: Zejula for Ovarian Cancer (May 31, 2020)
64 Table 13: Lynparza for Ovarian Cancer (May 29, 2020)
66 Table 14: Mirvetuximab Soravtansine for Ovarian Cancer (May 29, 2020)
67 Table 15: Multiple Drugs for Ovarian Cancer (May 29, 2020)
69 Table 16: Recentin for Ovarian Cancer (May 29, 2020)
70 Table 17: Vigil EATC for Ovarian Cancer (May 13, 2020)
71 Table 18: VB-111 for Ovarian Cancer (March 26, 2020)
72 Table 19: Multiple Drugs for Ovarian Cancer (March 12, 2020)
74 Table 20: Acelarin for Ovarian Cancer (March 10, 2020)
76 Table 21: DPX-Survivac for Ovarian Cancer (February 25, 2020)
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