FRa-high platinum-resistant ovarian cancer | Primary Research (KOL's Insight) | Market Intelligence | Epidemiology & Market Forecast-2035

FR is overexpressed in a number of epithelial malignancies, including ovarian cancer. Even though this protein is absent from healthy ovarian epithelium, nearly 80% of epithelial ovarian cancer (EOC) tumors express it constitutively. High receptor expression may also be a poor indicator of how well this disease will respond to chemotherapy. Ovarian cancer continues to be a leading cause of morbidity and mortality worldwide, with rising rates in many low- and middle-income countries and rising case numbers in high-income countries as a result of population aging. The proportion of women who pass away from their disease has not changed significantly over time when compared to other common cancer types, and the five-year relative survival rate is under 45%.

Description

Overexpression of FR is present in a number of epithelial malignancies, including ovarian cancer. Despite the fact that this protein is absent from healthy ovarian epithelium, 80% of epithelial ovarian cancer (EOC) tumors express FR constitutively; high receptor expression may also be a poor indicator of how well this disease will respond to chemotherapy. As a result, FR has gained popularity as a potential target for molecularly focused strategies that aim to utilize its variable distribution pattern as a new therapeutic avenue for EOC.

FRa-high platinum-resistant ovarian cancer (Epidemiology)

Due to population aging and rising rates in many low- and middle-income countries, ovarian cancer continues to be one of the leading causes of morbidity and mortality in the world. The percentage of female cancer fatalities has not changed significantly over time in comparison to other common cancer types, and the five-year relative survival rate is under 45%. The majority of the recognized risk and protective factors for epithelial ovarian cancer are connected to reproductive and hormonal factors. Tubal ligation, increased parity, and the use of oral contraceptives all markedly reduced risk, whereas a family history of ovarian or breast cancer, advanced menopause, obesity, the use of menopausal hormone therapy, a history of endometriosis, and smoking markedly increased risk. With 240,000 women receiving a diagnosis each year, ovarian cancer is the eighth most common cancer among women in the world and the seventh most common cause of cancer death. Additionally, it contributes to 150,00 deaths and has a five-year survival rate under 45%. The age-standardised incidence rates are highest in North and Central/Eastern Europe, intermediate in North America, Australia, and Western Europe, and lowest in Asia and Africa. The rates have been decreasing in many high incidence countries while increasing in many low incidence countries, making the differences less pronounced today than they were thirty years ago. Rates within countries vary depending on ethnicity; for instance, in the United States, non-Hispanic white women's rates are roughly 30% higher than those of African American and Asian women, and 16% higher than those of Hispanic women. The majority of cancers in this age group are germ cell tumors, and ovarian cancer is uncommon in women under the age of 40. The risk increases with age, peaking in the late 70s, and over 90% of tumors in people over the age of 40 are epithelial tumors.

FRa-high platinum-resistant ovarian cancer -Current Market Size & Forecast Trends

The market for FRa-high platinum-resistant ovarian cancer is expected to grow significantly, driven by advancements in targeted therapies and increasing patient awareness. The global ovarian cancer therapeutics market, which includes treatments for platinum-resistant cases, was valued at approximately USD 2.11 billion in 2023 and is projected to reach around USD 8 billion by 2034, reflecting a compound annual growth rate (CAGR) of 12.86%. A key driver of this growth is the recent approval of mirvetuximab soravtansine, the first targeted therapy specifically for FRa-positive platinum-resistant ovarian cancer, which has shown promising clinical outcomes with an overall response rate of 31.7% and a median duration of response of 6.9 months. The increasing incidence of ovarian cancer, estimated at about 20,000 new cases annually in the U.S., alongside the rising demand for effective treatment options for patients who have limited alternatives after multiple lines of chemotherapy, further supports market expansion. As new therapies continue to emerge and existing treatments are optimized, the market for FRa-high platinum-resistant ovarian cancer is well-positioned for robust growth through 2035.

FR-directed small molecule-folate conjugates (vintafolide) and monoclonal antibodies like farletuzumab (MORAb-003) were the main subjects of early research on FR. Despite having positive phase 2 results, neither method was successful in phase 3 trials. ADCs, or antibody-drug conjugates, have, however, shown greater promise. The FDA has put mirvetuximab soravtansine (IMGN853), an ADC, on fast-track approval for ovarian cancers in response to the recent readout of data from the phase 3 SORAYA trial (NCT04296890). Mirvetuximab soravtansine functions by the antibody binding to FR. When the molecule enters the cell through endocytosis, the antibody is dissociated from its ADC maytansinoid DM4 (DM4). Then, by inhibiting tubulin, DM4 exerts potent antimitotic activity, causing cell death. One advantage of DM4 is the potential for its active metabolites to diffuse into neighboring cells and cause bystander killing, making cells lacking the FR receptor also susceptible. The SORAYA trial met its primary end point of an improved ORR at 32.4% when compared to the 12-%standard of single-agent nonplatinum chemotherapy. The response lasted 5.9 months instead of the 3 to 4 months with chemotherapy that were expected. There were no new safety concerns discovered, and the adverse events (AEs) associated with mirvetuximab soravtansine were comparable to those in earlier studies. Due to treatment-related adverse events (TRAEs), 19% of patients had their doses reduced, 32% had their doses delayed, and 7% had their treatment stopped. Blurred vision (41% across all grades; 6% in grade 3), keratopathy (35% across all grades; 9% in grade 3), and nausea (29% across all grades; 0% in grade 3) were the most common TRAEs. If mirvetuximab soravtansine were approved, it would be the first medication to target the FR receptors. The FR-targeted medications necessitate careful patient selection. The mirvetuximab soravtansine FORWARD I trial (NCT02631876), which included medium (50-74% of cells) and high expression (> 75%) of FR on treated tumors, did not meet its primary end point of PFS improvement vs. however, the high-expression subgroup did show improvement after chemotherapy. Only patients with high levels of expression were included in the SORAYA trial as a result of this development, and it is likely that this will be reflected in the drug's intended use if it is approved.

Report Highlights

FRa-high platinum-resistant ovarian cancer - Current Market Trends

FRa-high platinum-resistant ovarian cancer - Current & Forecasted Cases across the G8 Countries

FRa-high platinum-resistant ovarian cancer - Market Opportunities and Sales Potential for Agents

FRa-high platinum-resistant ovarian cancer - Patient-based Market Forecast to 2035

FRa-high platinum-resistant ovarian cancer - Untapped Business Opportunities

FRa-high platinum-resistant ovarian cancer - Product Positioning Vis-a-vis Competitors' Products

FRa-high platinum-resistant ovarian cancer - KOLs Insight