PUBLISHER: DelveInsight | PRODUCT CODE: 1872643
PUBLISHER: DelveInsight | PRODUCT CODE: 1872643
DelveInsight's "Low-Grade Serous Ovarian Cancer (LGSOC)-Market Insight, Epidemiology, and Market Forecast-2034" report delivers an in-depth understanding of low-grade serous ovarian cancer, its historical and forecasted epidemiology, and the market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
The LGSOC market report provides current treatment practices, emerging drugs, LGSOC market share of individual therapies, and current and forecasted low-grade serous ovarian cancer market size from 2020 to 2034, segmented by seven major markets. The report also covers current low-grade serous ovarian cancer treatment practices/algorithms and unmet medical needs to curate the best of the opportunities and assess the underlying potential of the market.
Study Period: 2020-2034
Low-Grade Serous Ovarian Cancer (LGSOC) Overview
Ovarian cancer remains the most lethal gynecologic malignancy. Epithelial ovarian carcinoma (EOC) is the most frequent histological subtype. Based on histopathology, immunohistochemistry, and molecular analysis, EOCs are divided into five main subtypes: High-grade Serous Carcinomas (HGSOC), endometrioid carcinomas, clear-cell carcinomas, mucinous carcinomas, and Low-grade Serous Carcinomas (LGSOC). Recently, a 2-tier system in which tumors are subdivided into low-grade and high-grade has been proposed. Low-grade serous carcinomas exhibit low-grade nuclei with infrequent mitotic figures. They evolve from adenofibromas or borderline tumors, have frequent mutations of the KRAS, BRAF, or ERBB2 genes, and lack TP53 mutations. Low-grade tumors are indolent and have better outcomes than high-grade tumors.
Low-Grade Serous Ovarian Cancer (LGSOC) Diagnosis
LGSOC poses specific diagnostic challenges, often overlapping with serous borderline tumors. Pathological examination becomes pivotal, with micropapillary or cribriform features signaling potential aggressiveness and a resemblance to LGSOC behavior. Micro-invasion is present in serous borderline tumors but doesn't classify as LGSOC unless the morphology aligns with the latter. Lymph node involvement by serous borderline tumors is distinct and not considered metastatic. In the differential diagnosis, distinguishing low from high-grade serous carcinoma is crucial, as they represent distinct diseases with varying molecular profiles. Molecular profiling emerges as an opportunity for LGSOC patients, especially those with advanced-stage disease. Tumor profiling using next-generation sequencing often reveals KRAS or BRAF mutations, indicating oncogene activation, while lacking p53 loss-of-function mutations and homologous recombination deficiency. Molecular insights aid in confirming the LGSOC diagnosis, identifying treatment targets, and preventing misclassification.
Low-Grade Serous Ovarian Cancer (LGSOC) Treatment
The treatment of LGSOC primarily involves surgery, with complete cytoreduction offering the best outcomes. Fertility-sparing surgery may be considered in early-stage disease, while secondary cytoreduction is beneficial in recurrence. LGSOC is relatively chemoresistant, with platinum-based chemotherapy showing limited response; alternative cytotoxic regimens also have low efficacy and notable toxicity. Hormonal therapy, especially with aromatase inhibitors like letrozole or anastrozole, offers significant clinical benefit in both primary maintenance and recurrent settings, despite low objective response rates. Bevacizumab, an anti-angiogenic agent, has shown modest efficacy and is considered in both primary and recurrent settings. MEK inhibitors, such as trametinib, have demonstrated superior progression-free survival compared to standard therapies regardless of MAPK mutation status. CDK4/6 inhibitors (e.g., abemaciclib, ribociclib) and PI3K inhibitors (e.g., alpelisib) are emerging as promising targeted options, especially in combination with hormonal agents. Ongoing trials continue to evaluate their role, with early data supporting their efficacy and tolerability.
The LGSOC epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by the total incident cases of ovarian cancer, total incident cases of LGSOC, stage-specific cases of LGSOC, and biomarker-specific cases of LGSOC, line-wise treated cases of LGSOC in the 7MM market, covering the United States, EU4 (Germany, France, Italy, and Spain), and the United Kingdom, and Japan from 2020 to 2034.
The drug chapter segment of the LGSOC report encloses a detailed analysis of LGSOC's marketed drugs. It also deep dives into LGSOC's pivotal clinical trial details, market approvals, patent details, the latest news, and recent deals and collaborations.
Marketed Drugs
TAFINLAR (dabrafenib) + MEKINIST (trametinib): Novartis
TAFINLAR and MEKINIST target two different kinases in the RAS/RAF/MEK/ERK pathway. The use of TAFINLAR and MEKINIST in combination resulted in greater growth inhibition of BRAF V600 mutation-positive tumor cell lines in vitro and prolonged inhibition of tumor growth in BRAF V600 mutation-positive tumor xenografts compared with either drug alone.
In March 2023, the FDA approved TAFINLAR + MEKINIST for pediatric patients 1-year of age and older with LGG with a BRAF V600E mutation who require systemic therapy. The FDA also approved new oral formulations of both drugs suitable for patients who cannot swallow pills.
AVMAPKI (avutometinib) + FAKZYNJA (defactinib) Co-pack: Verastem Oncology
Avutometinib is an RAF/MEK Clamp that induces inactive complexes of MEK with ARAF, BRAF, and CRAF, potentially creating a more complete and durable antitumor response through maximal RAS pathway inhibition. Avutometinib blocks both RAF and MEK in a single molecule, suggesting it may help overcome resistance and ultimately block tumor growth and proliferation. By inhibiting RAF phosphorylation of MEK, avutometinib has the advantage of not inducing pMEK, and by inhibiting ERK signaling more completely, preliminary research indicates avutometinib may confer enhanced therapeutic activity. Defactinib is an oral, selective inhibitor of Focal Adhesion Kinase (FAK) and Proline-rich Tyrosine Kinase-2 (Pyk2), the two members of the focal adhesion kinase family of non-receptor protein tyrosine kinases.
In May 2025, the US FDA granted accelerated approval to the combination of AVMAPKI FAKZYNJA Co-pack for adult patients with KRAS-mutated recurrent LGSOC who have received prior systemic therapy.
Emerging Drugs
Ubamatamab (REGN4018): Regeneron Pharmaceuticals
Ubamatamab (REGN4018) is a MUC16 x cluster of differentiation 3 (MUC16xCD3) bispecific antibody that bridges MUC16 on tumor cells and CD3 on T cells to promote T cell-mediated cytotoxicity. Cemiplimab is an immune checkpoint inhibitor that targets the programmed cell death-1 (PD-1) receptor. The company is currently conducting Phase I/II trials alone or in combination with cemiplimab.
Low-grade Serous Ovarian Carcinoma (LGSOC) Drug Class Insights
Targeting the RAS/RAF/MEK/ERK pathway, also known as the MAPK pathway, has emerged as a promising therapeutic strategy in LGSOC, particularly in patients with specific genetic mutations.
Currently, two therapies dominate the LGSOC market: TAFINLAR and MEKINIST, which target different kinases within the MAPK cascade, and a novel combination therapy, AVMAPKI + FAKZYNJA, offering a differentiated mechanism of action. Avutometinib functions as a RAF/MEK clamp that forms inactive complexes with ARAF, BRAF, and CRAF, effectively suppressing MEK activation. By simultaneously inhibiting both RAF and MEK with a single molecule, avutometinib may offer more comprehensive and durable inhibition of the RAS/MAPK pathway. This dual targeting approach holds the potential to overcome resistance mechanisms and more effectively block tumor growth and proliferation in LGSOC.
Ovarian cancer treatment typically involves a combination of surgery, chemotherapy, and targeted therapy. Surgery aims to remove cancerous tissue, while chemotherapy, administered orally or intravenously, works to shrink or destroy cancer cells. Targeted therapy blocks cancer growth and spread and is used when specific tests confirm its suitability. Currently, there are only two marketed therapies and with few emerging companies developing treatments for LGSOC. The latest approval of AVMAPKI + FAKZYNJA co-pack may create an opportunity and awareness for the researchers and companies to investigate therapies for LGSOC.
Current key players in the field include Verastem Oncology and Novartis.
This section focuses on the rate of uptake of the potential drugs expected to be launched in the market during the study period. The analysis covers LGSOC market uptake by drugs, patient uptake by therapies, and sales of each drug.
Pipeline Development Activities
The report covers detailed information on collaborations, acquisitions and mergers, licensing, and patent details for ovarian cancer emerging therapies.
KOL Views
To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Some of the leaders like MDs, professors, and Vice Chair Department of Critical Care Medicine, and Director, PhD, and others. Their opinion helps to understand and validate current and emerging therapies and treatment patterns or ovarian cancer market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.
DelveInsight's analysts connected with 30+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centers such as the Dana-Farber Cancer Institute, Smilow Cancer Hospital, University of Chicago etc., were contacted. Their opinion helps understand and validate ovarian cancer epidemiology and market trends.
Qualitative Analysis
We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.
Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.
In efficacy, the trial's primary and secondary outcome measures are evaluated; for instance, in event-free survival, one of the most important primary outcome measures is event-free survival and overall survival.
Further, the therapies' safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.
Market Access and Reimbursement
Novartis Oncology Universal Co-pay Program: Eligible patients with private insurance may pay USD 0 per month (USD 0 per month for a 30-day supply of TAFINLAR and USD 0 for a 30-day supply of MEKINIST). Co-pay of USD 0 is only for TAFINLAR and MEKINIST combination therapy. Novartis will pay the remaining co-pay, up to USD 15,000 per calendar year, per product.