Disease Analysis: Ovarian Cancer
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 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 2.7%, and the average probability a drug advances from Phase III is 24.1%. Ovarian cancer drugs, on average, take 11.0 years from Phase I to approval, compared to 9.9 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. 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 and folate receptor alpha (FRα)-directed antibody-drug conjugate mirvetuximab soravtansine.
- 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.
- Multiple novel therapies are in development for the treatment of recurrent platinum-sensitive patients. These include the antibody-drug conjugate upifitamab rilsodotin, a novel engineered interleukin-2 immunotherapy nemvaleukin alfa, and the genetically engineered virus Olvi-Vec.
- 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 Tecentriq in the Phase III ATALANTE 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 regulatory submissions 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. Additionally, a PDUFA date for mirvetuximab soravtansine is expected before the end of 2022.
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
40 KEY REGULATORY EVENTS
40 Amneal Makes First Biosimilar Launch With US Bevacizumab
40 AstraZeneca And GSK Withdraw Drugs For Ovarian Cancer
41 Clovis Gambles On Rubraca For First-Line Ovarian Cancer Maintenance
41 Celltrion To Jostle For Space In Crowded EU Bevacizumab Market
41 EMA Restricts Rubraca’s Use Due To Concerns Over Benefit & Safety
42 CHMP Recommends Pan-EU Approval For Celdoxome Pegylated Liposomal
42 Innovent And Etana Get Indonesian Bevacizumab Nod
42 Celltrion Gets Ready To Face The Competition After European Bevacizumab Nod
43 Clovis Withdraws Rubraca’s Original Ovarian Cancer Indication, Shows FDA Emphasis On Survival Data
43 Viatris And Biocon Launch Bevacizumab Biosimilar In Canada
44 Amneal Scores Second US Biosimilar Approval With Avastin Rival
44 ImmunoGen Rests ADC Accelerated Approval Bid On SORAYA Trial
44 Accord Sees Two Hybrids Endorsed By EU’s CHMP
45 New Data Helps Darzalex & Zejula Switch To Routine Funding In England
45 On Target Aims To Light Up Ovarian Cancer Diagnosis
46 Apotex Begins Roll Out Of Avastin Biosimilar In Canada
47 PROBABILITY OF SUCCESS
48 LICENSING AND ASSET ACQUISITION DEALS
48 Innovent’s Former US Partner Coherus Returns Rights
48 Coeptis Takes Options On Three CAR-T Programs Developed At Pitt
48 Repare Gets Cash And Validation In DNA Damage Repair Alliance With Roche
49 Tianjin Tasly Inks $40m Licensing Deal With Sutro For ADC Cancer Treatment
49 Mersana Therapeutics Expands ADC Development Partnership With Synaffix
49 QIAGEN Signs Agreement With OncXerna Therapeutics To Develop Companion Diagnostic
51 CLINICAL TRIAL LANDSCAPE
52 Sponsors by status
53 Sponsors by phase
54 Recent events
58 DRUG ASSESSMENT MODEL
62 MARKET DYNAMICS
63 FUTURE TRENDS
63 Launches of new targeted therapies and label expansions will drive growth in the ovarian cancer market over the forecast period
63 Biomarker status will become increasingly important in treatment decisions
63 PARP inhibitors will remain the leading drug class within ovarian cancer
64 Competition will be fierce between PD-1/PD-L1 inhibitors in the first-line and first-line maintenance settings
65 CONSENSUS FORECASTS
67 RECENT EVENTS AND ANALYST OPINION
67 Tecentriq for Ovarian Cancer (September 9, 2022)
68 Ofra-Vec for Ovarian Cancer (July 19, 2022)
69 Rubraca for Ovarian Cancer (June 6, 2022)
71 Mirvetuximab Soravtansine for Ovarian Cancer (June 4, 2022)
73 Mirvetuximab Soravtansine for Ovarian Cancer (November 30, 2021)
74 Relacorilant for Ovarian Cancer (September 17, 2021)
76 DPX-Survivac for Ovarian Cancer (August 10, 2021)
78 Relacorilant for Ovarian Cancer (May 7, 2021)
81 KEY UPCOMING EVENTS
82 KEY OPINION LEADER INSIGHTS
83 UNMET NEEDS
83 Treating platinum-resistant/refractory ovarian cancer
83 Improved testing for earlier detection
84 BIBLIOGRAPHY
86 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
47 Figure 6: Probability of success in the ovarian cancer pipeline
51 Figure 7: Clinical trials in ovarian cancer
51 Figure 8: Top 10 drugs for clinical trials in ovarian cancer
52 Figure 9: Top 10 companies for clinical trials in ovarian cancer
52 Figure 10: Trial locations in ovarian cancer
53 Figure 11: Ovarian cancer trials status
54 Figure 12: Ovarian cancer trials sponsors, by phase
58 Figure 13: Datamonitor Healthcare’s drug assessment summary for ovarian cancer
62 Figure 14: Market dynamics in ovarian cancer
63 Figure 15: Future trends in ovarian cancer
68 Figure 16: Tecentriq for Ovarian Cancer (September 9, 2022): Phase III – ATALANTE (w/Bevacizumab)
71 Figure 17: Rubraca for Ovarian Cancer (June 6, 2022): Phase III – ATHENA (w/Opdivo)
74 Figure 18: Mirvetuximab Soravtansine for Ovarian Cancer (November 30, 2021): Phase III – SORAYA
76 Figure 19: Relacorilant for Ovarian Cancer (September 17, 2021): Phase II – w/Nab-Paclitaxel
78 Figure 20: DPX-Survivac for Ovarian Cancer (August 10, 2021): Phase Ib/II – DeCidE1
80 Figure 21: Relacorilant for Ovarian Cancer (May 7, 2021): Phase II – w/Nab-Paclitaxel
81 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
65 Table 5: Historical global sales, by drug ($m), 2017–21
66 Table 6: Forecasted global sales, by drug ($m), 2022–26
67 Table 7: Tecentriq for Ovarian Cancer (September 9, 2022)
69 Table 8: Ofra-Vec for Ovarian Cancer (July 19, 2022)
70 Table 9: Rubraca for Ovarian Cancer (June 6, 2022)
72 Table 10: Mirvetuximab Soravtansine for Ovarian Cancer (June 4, 2022)
73 Table 11: Mirvetuximab Soravtansine for Ovarian Cancer (November 30, 2021)
75 Table 12: Relacorilant for Ovarian Cancer (September 17, 2021)
77 Table 13: DPX-Survivac for Ovarian Cancer (August 10, 2021)
79 Table 14: Relacorilant for Ovarian Cancer (May 7, 2021)
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