JEMPERLI Approved in EU for Endometrial Cancer

According to MarketScreener, patients with endometrial cancer in Europe now have a new treatment option. Recently, the European Commission (EC) granted conditional marketing authorization to GlaxoSmithKline for their therapy JEMPERLI (dostarlimab), which they licensed from AnaptysBio. The treatment is designed for patients with mismatch repair-deficient (dMMR)/microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer. In particular, these patients also have cancer which progressed despite chemotherapy.

JEMPERLI (Dostarlimab)

So what is JEMPERLI (dostarlimab)? This infusion is a monotherapy for patients with recurrent or advanced endometrial cancer. It blocks programmed death receptor-1 (PD-1) and prevents PD-1 from engaging with PD-L1 or PD-L2. As described by the National Cancer Institute (NCI), PD-1 is:

A protein found on T cells (a type of immune cell) that helps keep the body’s immune responses in check. When PD-1 is bound to another protein called PD-L1, it helps keep T cells from killing other cells, including cancer cells.

By blocking PD-1 from binding to PD-L1 or PD-L2, the T-cells become stronger and promote a better immune response. Now, the therapy’s approval was based on data from the Phase 1 GARNET clinical trial. Altogether, 515 patients enrolled. Within Phase 2B, researchers are exploring JEMPERLI as a potential treatment for patients with:

  • Non-small cell lung cancer (NSCLC)
  • dMMR/MSI-H endometrial cancer
  • Treatment-averse ovarian cancer with no BRCA gene mutations
  • MMRp/MSS endometrial cancer
  • dMMR/MSI-H solid tumors

Altogether, the trial determined that:

  • JEMPERLI prompted a response in around 43.5% of patients and controlled cancer progression in around 55.6% of patients.
  • Overall, the response was sustained over a 6-12 month period in a majority of patients.
  • JEMPERLI was relatively safe and well-tolerated. However, some side effects did occur. These include:
    • Nausea and vomiting
    • Diarrhea
    • Anemia (low red blood cell count)
    • Joint pain
    • Fever
    • Rash
    • Intense itching
    • Hypothyroidism or hyperthyroidism
    • Adrenal insufficiency

Other potential complications associated with JEMPERLI include:

  • Infusion-related reactions
  • Immune reactions, such as colitis, pneumonitis, hepatitis, nephritis, endocrinopathies, or uveitis
  • Graft-versus-host disease (GvHD)

Endometrial Cancer

Endometrial cancer first develops in the endometrium, or the cells which form the uterine lining. Ultimately, it is the most common form of uterine cancer, although other cancers may occur. Risk factors for developing endometrial cancer include obesity, being older, hormone therapy (for breast cancer), changes in female hormones, early menstruation or late menopause, and never being pregnant. Symptoms include:

  • Abnormal vaginal bleeding between periods
  • Pelvic pain
  • Vaginal bleeding following menopause
  • Pain during sexual intercourse
  • Difficult or painful urination

Learn more about endometrial cancer.

Jessica Lynn

Jessica Lynn

Jessica Lynn has an educational background in writing and marketing. She firmly believes in the power of writing in amplifying voices, and looks forward to doing so for the rare disease community.

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