Dostarlimab-gxly (Jemperli)

How is this drug name pronounced?

Dostarlimab: dos-TAR-lih-mab

Jemperli:  jem-PER-lee


What cancer(s) does this drug treat?

Endometrial cancer

Jemperli is approved for:

Limitations of use:

Age: The safety and efficacy of Jemperli in patients under 18 years of age have not been established.
Fertility/Pregnancy/Breastfeeding: Jemperli can cause harm to a fetus and is not recommended for use during pregnancy. Pregnancy should be prevented during treatment with Jemperli and for at least four months after the last dose of Jempeli. The risks associated with Jemperli during breastfeeding are not known and cannot be ruled out. Due to the potential for serious adverse reactions in the breastfed child, women are advised not to breastfeed during treatment and for at least four months after the last dose of Jemperli.
Complications of stem cell transplant: Serious and life-threatening transplant-related complications can occur in patients who receive a stem cell transplant from a donor before or after being treated with Jemperli.


What type of immunotherapy is this?


How does this drug work?

Jemperli is an antibody that attaches to a molecule called PD-1, which is present on the surface of T cells. In healthy T cells, PD-1 acts as a brake that prevents the cells from creating an out-of-control immune response. However, in tumors, PD-1 can make T cells inactive and can prevent them from doing their job of killing the cancer cells. This happens because cancer cells or other cells within the tumor have an increased concentration of PD-L1 and PD-L2 molecules on their cell surface, which attach to PD-1. When PD-L1 and PD-L2 interact with the PD-1 receptor on the T cell, the T cell is inactivated and cannot do its job of killing the cancer cells. Jemperli binds to the PD-1 on the T cells in a way that blocks PD-L1 and PD-L2 from interacting with the PD-1 receptor. This blockade on PD-1 allows the T cells to activate and to attack and kill cancer cells.

Illustration showing how Jemperli works


How is this drug given to patients?

Jemperli is administered via a tube into a vein (intravenous infusion or i.v.) over the course of 30 minutes. For the first three months of treatment, Jemperli is administered every three weeks, for a total of four doses. After that, Jemperli is administered every six weeks.


What are the observed clinical results?

It is important to keep in mind that each patient’s actual outcome is individual and may be different from the results found in the clinical studies. In addition, with immunotherapy, sometimes it takes several months for responses to be observed.

Endometrial cancer

In a clinical trial, 71 patients with endometrial cancer who had been previously treated with platinum-containing chemotherapy and the treatment either did not work or stopped working and the cancer had gotten worse or had since come back, and whose cancer was mismatch repair-deficient (dMMR), were treated with Jemperli. At a median follow-up of 14 months:

Results after treatment with Jemperli (diagram)


What are the side effects?

The most common side effects of Jemperli are fatigue, nausea, diarrhea, constipation and low red blood cell counts (anemia).

Jemperli can cause a patient’s T cells to attack healthy cells throughout the body. Because of this, Jemperli can cause side effects that can become serious or life-threatening. Some of the serious side effects related to Jemperli include inflammation of the lungs, colon, liver, or kidneys. Additionally, problems can arise with hormone glands (including thyroid, pituitary, and adrenal glands, as well as the pancreas). Jemperli may cause Type 1 diabetes. Serious skin problems, severe infections, and reactions related to the infusion may also occur.

Jemperli can cause serious and life-threatening complications, including graft-versus-host disease in patients who have received a stem cell transplant before or after being treated with Jemperli.. These complications may arise even if patients have been treated with other types of therapy in between administration of Jemperli and stem cell transplant.

Patients should report any symptoms to their healthcare provider, who can then initiate actions to limit or reverse the side effects. For a more complete list of possible side effects, see the full prescribing information.


Additional Information

Manufacturer:

  • GlaxoSmithKline

Approval:

  • FDA
  • EMA

Last updated on April 23, 2021


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