Jemperli

In Clinical Studies News by Barbara Jacoby

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From: breastcancer.org

Jemperli (chemical name: dostarlimab-gxly) is approved by the U.S. Food and Drug Administration (FDA) to treat mismatch repair deficient (dMMR) advanced-stage breast cancer that has grown during or after treatment if no other treatment options are available.

Jemperli also is approved to treat dMMR advanced-stage endometrial cancer that has grown after treatment with platinum chemotherapy.

How Jemperli works

Jemperli is a type of immunotherapy called an immune checkpoint inhibitor. Immune checkpoints are proteins in your body that help your immune system tell the difference between your own cells and foreign invaders, such as harmful bacteria. Cancer cells sometimes find ways to use these immune checkpoint proteins as a shield to avoid being identified and attacked by the immune system.

Immune checkpoint inhibitors target these immune checkpoint proteins and help the immune system recognize and attack cancer cells. PD-1 is a type of checkpoint protein found on T cells, which are immune system cells that roam throughout the body looking for signs of disease or infection. PD-L1 is another checkpoint protein found on many healthy cells in the body. When PD-1 binds to PD-L1, it stops T cells from killing a cell.

Still, some cancer cells have a lot of PD-L1 on their surface, which stops T cells from killing these cancer cells. An immune checkpoint inhibitor medicine like Jemperli that stops PD-1 from binding to PD-L1 allows T cells to attack the cancer cells.

Is Jemperli right for you?

Jemperli is approved to treat mismatch repair deficient (dMMR) advanced-stage breast cancer that has grown during or after treatment if no other treatment options are available.

Healthy cells have a process — called the mismatch repair system — to find and repair mistakes that happen when DNA is copied. In some cases, this system stops working and DNA errors build up, which can lead to cancer. When the mismatch repair system stops working, it’s called dMMR.

Fewer than 1% of breast cancers have the dMMR biomarker.

If you’ve been diagnosed with advanced-stage breast cancer that has grown during or after treatment and no other treatment options are available, your doctor may recommend testing for dMMR. If the cancer has the dMMR biomarker, Jemperli may be an option for you.

What to expect when taking Jemperli

Jemperli is given as a 30-minute infusion. You receive the first four doses every 3 weeks. After that, you receive the remaining doses every 6 weeks.

Your doctor should not recommend Jemperli to you if you are pregnant or planning to get pregnant. Jemperli can cause embryo death and birth defects. It’s important that you don’t get pregnant if Jemperli is part of your treatment plan. You must use effective birth control while receiving Jemperli infusions and for 4 months after your last dose.

Jemperli side effects

Like most cancer treatments, Jemperli can cause side effects, some of them severe.

The most common side effects of Jemperli are:

Jemperli also can cause other serious side effects, including:

  • Pneumonia: Jemperli may cause inflammation of the lungs, which can be life-threatening. Symptoms include trouble breathing, worsening cough, and chest pain.
  • Colitis (inflammation of the inner lining of the colon): Symptoms include diarrhea, blood or mucus in your stool, and severe stomach pain.
  • Liver problems: Jemperli may cause hepatitis (inflammation of the liver). Tell your doctor right away if you have yellowing of your skin or the whites of your eyes, dark-colored urine, bleeding or bruising more easily than normal, severe nausea or vomiting, or pain on the right side of your stomach area.
  • Hormone gland problems: Jemperli may affect glands that make certain hormones your body needs to function properly, including the thyroid, adrenal glands, pancreas, and pituitary gland. Symptoms include headaches that won’t go away, extreme tiredness, weight gain or loss, changes in mood or behavior, feeling cold, and constipation.
  • Skin problems: Jemperli may cause life-threatening inflammation of the skin and mucus membranes. Tell your doctor right away if you develop a painful rash and blisters that peel and weep. Your skin also may be itchy, red, and scaly.
  • Severe infection: Symptoms include fever, cough, flu-like symptoms, pain when urinating, or back pain.

References

  1. Jemperli (dostarlimab-gxly) prescribing information. GlaxSmithKline, USA. Available at: https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Jemperli/pdf/JEMPERLI-PI-MG.PDF (PDF)