Jemperli is a prescription medicine used for the treatment of mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) endometrial cancer, and dMMR solid tumors.

Jemperli belongs to the class of drugs called programmed death receptor-1 (PD-1)–blocking antibodies. In healthy T-cells, PD-1 acts as a brake that prevents the cells from creating an out-of-control immune response, but in tumors, PD-1 can make T-cells inactive preventing them from killing cancer cells.

Jemperli works in the treatment of dMMR/MSI-H endometrial cancer and dMMR solid tumors by binding to the PD-1 receptor on T-cells to block the interaction with the PD-1 ligands PD-L1 and PD-L2, allowing the T-cells to activate and to attack and kill the cancer cells.

What is Jemperli used to treat?

Jemperli is used to treat mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) endometrial cancer, and dMMR solid tumors. 

Endometrial cancer is a cancer that forms in the endometrium (lining of the uterus). Solid tumors are abnormal masses of tissue devoid of fluids or cysts. In normal cells, mismatch repair (MMR) is a process that corrects errors introduced during DNA replication via enzymes. When the repair mechanism is defective, it is known as mismatch repair-deficient (dMMR), and may lead to an accumulation of errors in the DNA that can cause cancer. Microsatellite instability (MSI) is the condition that results from impaired MMR. MSI-high (MSI-H) means that there is a high amount of instability in a tumor.

Jemperli is used in combination with the chemotherapy medicines carboplatin and paclitaxel, followed by Jemperli as a single agent for the treatment of adult patients with primary advanced (has spread outside the uterus) or recurrent (has returned) endometrial cancer that is mismatch repair deficient (dMMR), as determined by an FDA-approved test, or microsatellite instability-high (MSI-H).

Jemperli is used as a single agent for the treatment of adult patients with dMMR recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed during treatment or after treatment, and there are no satisfactory treatment options.

Jemperli is also as a single agent for the treatment of adult patients with dMMR recurrent or advanced solid tumors, as determined by an FDA-approved test, that have progressed during treatment or after treatment, and there are no satisfactory treatment options.

It is not known if Jemperli is safe and effective in children.

Jemperli can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. These problems may happen anytime during treatment or even after your treatment with Jemperli has ended.

Call or see your healthcare provider right away if you develop any symptoms of the following problems or if these symptoms get worse:

Lung problems (pneumonitis). Symptoms of pneumonitis may include:

• cough
• chest pain
• shortness of breath

Intestinal problems (colitis) that can lead to tears or holes in your intestine. Signs and symptoms of colitis may include:

• diarrhea or more bowel movements than usual
• stools that are black, tarry, sticky, or have blood or mucus
• severe stomach-area (abdomen) pain or tenderness

Liver problems, including hepatitis. Signs and symptoms of liver problems may include:

• yellowing of your skin or the whites of your eyes
• severe nausea or vomiting
• pain on the right side of your stomach area (abdomen)
• dark urine (tea colored)
• bleeding or bruising more easily than normal

Hormone gland problems (especially the adrenal glands, pituitary, thyroid, and pancreas). Signs and symptoms that your hormone glands are not working properly may include:

• headaches that will not go away or unusual headaches
• eye sensitivity to light
• eye problems
• rapid heartbeat
• increased sweating
• extreme tiredness
• weight gain or weight loss
• feeling more hungry or thirsty than usual
• urinating more often than usual
• hair loss
• feeling cold
• constipation
• your voice gets deeper
• dizziness or fainting
• changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness

Kidney problems, including nephritis and kidney failure. Signs of kidney problems may include:

• change in the amount or color of your urine
• blood in your urine
• swelling in your ankles
• loss of appetite

Skin problems. Signs of skin problems may include:

• rash
• itching
• skin blistering or peeling
• swollen lymph nodes
• painful sores or ulcers in your mouth or in your nose, throat, or genital area
• fever or flu-like symptoms

Problems in other organs and tissues. These are not all of the signs and symptoms of immune system problems. Call or see your healthcare provider right away for any new or worse signs or symptoms. Signs and symptoms of these problems may include:

• chest pain, irregular heartbeat, shortness of breath, swelling of ankles
• confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs
• double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight
• persistent or severe muscle pain or weakness, muscle cramps
• low red blood cells, bruising

Infusion reactions that can sometimes be severe and life-threatening. Signs and symptoms of infusion reactions may include:

• chills or shaking
• itching or rash
• flushing
• shortness of breath or wheezing
• dizziness
• feeling like passing out
• fever
• back or neck pain

Rejection of a transplanted organ. Your healthcare provider should tell you what signs and symptoms you should report and monitor you, depending on the type of organ transplant that you have had.

Complications, including graft-versus-host-disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be severe and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with Jemperli. Your healthcare provider will monitor you for the following signs and symptoms: skin rash, liver inflammation, stomach area (abdominal) pain, and diarrhea.

Getting medical treatment right away may help keep these problems from becoming more serious.

Your healthcare provider will check you for these problems during treatment. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment, if you have severe side effects.

• Your healthcare provider will give you Jemperli into your vein through an intravenous (IV) line over 30 minutes.
• When Jemperli is used in combination with carboplatin and paclitaxel, Jemperli is usually given every 3 weeks for the first 6 doses. Beginning 3 weeks later, it is usually given alone every 6 weeks.
• When Jemperli is used alone to treat dMMR recurrent or advanced endometrial cancer and dMMR recurrent or advanced solid tumors, it is usually given every 3 weeks for the first 4 doses. Beginning 3 weeks later, it is usually given every 6 weeks.
• Your healthcare provider will decide how many treatments you need.
• Your healthcare provider will do blood tests to check you for side effects.
• If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.

Usual Adult Dose for Endometrial Carcinoma:

Jemperli in combination with carboplatin and paclitaxel, for dMMR or MSI-H primary advanced or recurrent endometrial cancer:

-  500 mg IV over 30 minutes every 3 weeks for 6 doses followed by 1,000 mg monotherapy every 6 weeks.

Jemperli as a single-agent, for dMMR recurrent or advanced endometrial cancer:

- 500 mg IV over 30 minutes every 3 weeks for 4 doses followed by 1,000 mg every 6 weeks.

Uses:
- in combination with carboplatin and paclitaxel, followed by monotherapy for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR), as determined by an FDA-approved test, or microsatellite instability-high (MSI-H).
- as a single agent for the treatment of adult patients with dMMR recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following prior treatment with a platinumcontaining regimen in any setting and are not candidates for curative surgery or radiation.

Usual Adult Dose for Solid Tumors:

Jemperli as a single-agent, for dMMR recurrent or advanced solid tumors:

- 500 mg IV over 30 minutes every 3 weeks for 4 doses followed by 1,000 mg every 6 weeks.

Use:
- as a single agent for the treatment of adult patients with dMMR recurrent or advanced solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options.
This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). 

Before you receive Jemperli, tell your healthcare provider if you have any medical conditions, including if you:

• have immune system problems, such as Crohn’s disease, ulcerative colitis, or lupus.
• have received an organ transplant.
• have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic).
• have received radiation treatment to your chest area.
• have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome.

Pregnancy

Tell your healthcare provider if you are pregnant or plan to become pregnant. Jemperli can harm your unborn baby.

Females who are able to become pregnant:

• Your healthcare provider will do a pregnancy test before you start treatment.
• You should use effective birth control during treatment and for 4 months after your last dose. Talk to your healthcare provider about birth control methods that you can use during this time.
•  Tell your healthcare provider right away if you think you may be pregnant or if you become pregnant during treatment with Jemperli.

Breastfeeding

Tell your healthcare provider are breastfeeding or plan to breastfeed. It is not known if Jemperli passes into your breast milk.

• Do not breastfeed during treatment and for 4 months after your last dose.

Get emergency medical help if you have signs of an allergic reaction to Jemperli (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Some side effects may occur during the injection. Tell your caregiver if you feel light-headed, chilled or feverish, itchy, or short of breath.

Jemperli strengthens your immune system to help it attack cancer cells, but it may also attack healthy cells and you could develop serious or fatal side effects. See Important information.

Common Jemperli side effects when given with carboplatin and paclitaxel in people with dMMR/MSI-H endometrial cancer include:

• rash
• diarrhea
• decreased thyroid function
• high blood pressure.

Common Jemperli side effects when used alone in people with dMMR solid tumors (including endometrial cancer) when used alone include:

• tiredness and weakness
• low red blood cell count (anemia)
• diarrhea
• nausea
• constipation
• vomiting.

This is not a complete list of side effects of Jemperli and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.