Endometrial cancer is a type of uterine cancer that is often diagnosed early and treated with surgery, chemotherapy or hormone therapy. Patients who present with advanced disease or who relapse after surgery have few options available, including chemotherapy, hormone therapy and off-label targeted therapies in the first line, with the addition of immunotherapy in the second line.

There has historically been a lack of interest from drug developers to seek approvals for endometrial cancer. As a result, a significant amount of off-label drug use is recommended in the National Comprehensive Cancer Network (NCCN) guidelines. But recent advancements in the oncology market, specifically with biomarker testing and immunotherapy, have resulted in an increased interest in this market. GlobalData forecasts that these advancements will have a significant impact on the disease’s treatment paradigm, competitive landscape and attainment of unmet needs.

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Endometrial cancer patients do not currently have a standardised biomarker testing routine, with only some hormone and human epidermal growth factor receptor 2 (HER-2) biomarker testing being performed. Due to the recent approval of Merck and Co’s Keytruda (pembrolizumab) in combination with Eisai’s Lenvima (lenvatinib), mismatch repair (MMR) and microsatellite instability (MSI) testing is also being performed.

The approval of this first immunotherapy in endometrial cancer has resulted in increased interest by other drug developers, reflected in the late-stage pipeline. Key opinion leaders (KOLs) interviewed by GlobalData believe that biomarkers will be significant in determining patient segmentation in endometrial cancer and will identify patient populations likely to benefit from novel therapies.

Supporting this expectation is the recent approval of Roche’s Ventana MMR RxDx panel. This is the first immunohistochemistry predictive test to be used as a companion test to GlaxoSmithKline’s Jemperli (dostarlimab), which received accelerated approval for monotherapy use by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA). This panel, which determines a patient’s MMR status, is expected to introduce a new era of biomarker testing in endometrial cancer. Advanced and recurrent patients will now need to be segmented according to their MMR/MSI status to be eligible for the two approved therapies.

With the projected arrival of more pipeline agents, GlobalData expects that therapies will either fit into this patient segmentation or result in the development of further biomarkers to determine other segmentations. The Cancer Genome Atlas (TCGA) had previously determined four principal diagnostic groups in endometrial cancer patients, namely polymerase epsilon (POLE) mutated, MSI-high, copy number low (CNL) and copy number high (CNH). As novel therapies aim to gain approval for these groups, mostly based on MSI status, GlobalData anticipates that future drug developers will tailor clinical trials and seek specific approvals for the remaining diagnostic groups.

GlobalData projects that this will result overall in several unmet needs being met in endometrial cancer. This will both benefit current patients and create more market opportunities for new entrants, resulting in a greater patient population being served. In the future, it will become clearer which patients are well served by current and upcoming therapies and which patients still require novel therapies to be developed, thereby highlighting opportunities for drug stakeholders and promoting a novel competitive landscape in the endometrial cancer market.