Jemperli

Endometrial Cancer

Jemperli is approved for use in adults with endometrial cancer (cancer of the lining of the uterus) in the following situations:

• In combination with chemotherapy: It may be used along with carboplatin and paclitaxel, followed by Jemperli alone, for primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H).
• As a single agent: It may be used alone for dMMR recurrent or advanced endometrial cancer that has worsened during or after treatment with a platinum-containing chemotherapy medicine.

Other Solid Tumors

Jemperli is also used as a single agent to treat adults with dMMR recurrent or advanced solid tumors. This use is intended for patients whose cancer has progressed during or after previous treatment and who have no other satisfactory treatment options.

Genetic Testing

This medication is only used for tumors that have specific genetic features known as mismatch repair deficiency (dMMR) or microsatellite instability-high (MSI-H). These conditions affect how cells repair DNA. A healthcare provider will perform a laboratory test to confirm the presence of these markers before starting treatment.

Immune System Activation

Jemperli is a type of immunotherapy known as a monoclonal antibody. It works by targeting the programmed death receptor-1 (PD-1) pathway, which is a checkpoint the body uses to manage immune responses.

Under normal conditions, the PD-1 pathway helps prevent the immune system from attacking the body's own healthy cells. However, some cancer cells can hijack this pathway. By binding to PD-1 receptors on T-cells (a type of white blood cell), cancer cells can send a signal that tells the immune system to stop attacking. This allows the tumor to grow and spread undetected.

How Jemperli Works

Jemperli works by blocking the PD-1 receptor. When the medication binds to these receptors, it prevents cancer cells from sending the stop signal to the immune system. This helps the body's natural defenses to:

• Identify cancer cells as harmful invaders.
• Reactivate T-cells so they can attack the tumor.
• Slow down or stop the progression of the cancer.

This treatment is often used for cancers that have a genetic feature called mismatch repair deficiency (dMMR). These tumors are more likely to be recognized and attacked by the immune system once the PD-1 pathway is blocked.

Common Side Effects

The most common side effects reported by people taking Jemperli include:

• Fatigue and weakness
• Nausea and vomiting
• Diarrhea or constipation
• Anemia (low red blood cell count)
• Rash or itchy skin
• Muscle or joint pain
• Cough
• Decreased appetite

Serious Side Effects

Jemperli is an immunotherapy that can cause the immune system to attack healthy parts of the body. These immune-mediated side effects can occur in any organ and may include:

• Lung problems: Symptoms such as shortness of breath, chest pain, or a new or worsening cough.
• Intestinal problems: Severe stomach pain, diarrhea, or stools that are black, tarry, or contain blood.
• Liver problems: Yellowing of the skin or the whites of the eyes, dark urine, or pain on the right side of the stomach area.
• Hormone gland problems: Issues with the thyroid, pituitary, or adrenal glands, which may cause headaches, extreme tiredness, weight changes, or dizziness.
• Kidney problems: A decrease in the amount of urine or blood in the urine.
• Severe skin reactions: Rash, itching, skin blistering, or painful sores in the mouth or nose.
• Infusion reactions: Chills, shaking, dizziness, or fever during or shortly after the infusion.

Immune-Mediated Adverse Reactions

Jemperli can cause the immune system to attack healthy organs and tissues in any part of the body. These reactions can occur during treatment or after treatment has stopped. Serious or life-threatening inflammation may affect the following areas:

• Lungs: Pneumonitis may cause new or worsening cough, chest pain, or shortness of breath.
• Intestines: Colitis can lead to diarrhea, blood or mucus in stools, and severe stomach-area pain.
• Liver: Hepatitis may cause yellowing of the skin or eyes, dark urine, or pain on the right side of the stomach area.
• Hormone Glands: Problems with the thyroid, pituitary, or adrenal glands can cause headaches, extreme tiredness, weight changes, or dizziness.
• Kidneys: Nephritis can lead to changes in urine output or swelling in the ankles.
• Skin: Severe skin reactions, including rash, itching, or blistering, may occur.

Infusion-Related Reactions

Severe or life-threatening reactions can occur during the intravenous infusion. Symptoms may include chills, shaking, dizziness, fever, or wheezing. Medical staff monitor for these reactions during the administration of the drug.

Pregnancy and Reproduction

Based on its mechanism of action, Jemperli can cause fetal harm when administered to a pregnant person. Effective contraception is recommended for females of reproductive potential during treatment and for four months after the last dose. It is also advised not to breastfeed during treatment and for four months after the final dose.

Stem Cell Transplant Risks

Complications, including graft-versus-host disease (GVHD), can occur in people who receive an allogeneic hematopoietic stem cell transplant (HSCT) after being treated with a PD-1/PD-L1 blocking antibody like Jemperli.

Pregnancy

Jemperli can cause harm to a developing fetus. Healthcare providers typically require a pregnancy test before starting treatment to confirm the patient is not pregnant.

Individuals who can become pregnant should use effective birth control during treatment and for at least 4 months after the final dose. If a patient becomes pregnant while receiving this medication, they should contact their doctor immediately to discuss the potential risks.

Breastfeeding

It is not known if Jemperli passes into breast milk. Because of the risk of serious side effects in a nursing infant, breastfeeding is not recommended during treatment and for 4 months after the last dose.

Dosage Forms

Jemperli is available in the following form:

• Injection: A sterile, preservative-free solution supplied in a single-dose vial.

The medication is a clear to slightly opalescent, colorless to yellow liquid intended for dilution and intravenous infusion.

FDA Approval and Indications

Jemperli (dostarlimab-gxly) is an FDA-approved immunotherapy. It is used to treat adults with specific types of cancer that are mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H). These markers are identified through laboratory testing.

The FDA has approved Jemperli for the following conditions:

• Endometrial Cancer: It is approved for use with the chemotherapy drugs carboplatin and paclitaxel, followed by Jemperli alone, for primary advanced or recurrent endometrial cancer that is dMMR or MSI-H. It is also approved as a single treatment for dMMR recurrent or advanced endometrial cancer that has worsened after previous treatment with platinum-based chemotherapy.
• Solid Tumors: It is approved as a single treatment for adults with dMMR recurrent or advanced solid tumors that have progressed after prior treatment and when no other satisfactory treatment options are available.

Regulatory Status

The approval for treating solid tumors was granted under the FDA accelerated approval program. This means the drug was approved based on early evidence showing it is likely to provide a clinical benefit. Further studies may be required to confirm these benefits to maintain this specific approval. Jemperli does not have any boxed warnings or special safety programs (REMS) required by the FDA.

Factors Influencing Cost

Jemperli is a specialty medication administered as an intravenous (IV) infusion by a healthcare professional. Because it is not a drug you purchase at a standard retail pharmacy, the total cost typically includes several different components:

• Insurance Coverage: Most private insurance plans, Medicare, and Medicaid may cover Jemperli, but your specific out-of-pocket expenses will depend on your plan's deductibles, copayments, or coinsurance.
• Prior Authorization: Many insurance providers require a prior authorization process, where your healthcare provider must submit documentation to confirm the medical necessity of the treatment before coverage is approved.
• Administration Fees: In addition to the cost of the medication itself, you may be billed for the clinical services, supplies, and nursing time required to administer the infusion.
• Facility Type: The price can vary depending on whether the treatment is received in a hospital outpatient setting, a doctor's office, or a specialized infusion center.

Financial Assistance

For patients who are uninsured or have high out-of-pocket costs, financial assistance programs may be available. These programs are often provided by the manufacturer or through third-party foundations to help eligible individuals access treatment. Patients are encouraged to speak with their healthcare team or a financial counselor at their treatment facility to explore these options and obtain a specific cost estimate.