Dostarlimab

Binding of the PD-1 ligands, PD-L1 and PD-L2, to the PD-1 receptor found on T cells inhibits T-cell proliferation and cytokine production. Upregulation of PD-1 ligands occurs in some tumors, and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumors.

• JEMPERLI is a programmed death receptor-1 (PD-1)–blocking antibody indicated: Endometrial Cancer • in combination with carboplatin and paclitaxel, followed by JEMPERLI as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial cancer (EC). ( 1.1 ) • as a single agent for the treatment of adult patients with mismatch repair deficient (dMMR) recurrent or advanced EC, as determined by an FDA-approved test, that has progressed on or following prior treatment with a platinum-containing regimen in any setting and are not candidates for curative surgery or radiation.

• None. None.contraindicated

• JEMPERLI, in combination with carboplatin and paclitaxel, for primary advanced or recurrent EC: 500 mg every 3 weeks for 6 cycles followed by 1,000 mg monotherapy every 6 weeks for all cycles thereafter. ( 2.2 ) • JEMPERLI, as a single agent, for dMMR recurrent or advanced EC: 500 mg every 3 weeks for 4 cycles followed by 1,000 mg every 6 weeks for all cycles thereafter. ( 2.2 ) • JEMPERLI, as a single agent, for dMMR recurrent or advanced solid tumors: 500 mg every 3 weeks for 4 cycles followed by 1,000 mg every 6 weeks for all cycles thereafter. ( 2.2 ) • Administer as an intravenous infusion over 30 minutes. ( 2.2 ) • For complete dosing instructions, see full prescribing information. 2.1 Patient Selection Single Agent Select patients for treatment with JEMPERLI as a single agent based on the presence of dMMR in tumor specimens in: • recurrent or advanced EC [see Clinical Studies ( 14.1 )] . • recurrent or advanced solid tumors [see Clinical Studies ( 14.2 )] . Information on FDA-approved tests for the detection of dMMR status is available at https://www.fda.gov/companiondiagnostics . Because the effect of prior chemotherapy on test results for dMMR in patients with high-grade gliomas is unclear, it is recommended to test for this marker in the primary tumor specimen obtained prior to initiation of temozolomide chemotherapy in patients with high-grade gliomas. 2.2 Recommended Dosage The recommended dosage for JEMPERLI is presented in Table 1 . Table 1. Recommended Dosage of JEMPERLI dMMR = Mismatch Repair Deficient; EC = endometrial cancer.

• Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, including the following: immune‑mediated pneumonitis, immune-mediated colitis, immune‑mediated hepatitis, immune-mediated endocrinopathies, immune-mediated nephritis with renal dysfunction, immune‑mediated dermatologic adverse reactions, and solid organ transplant rejection. Monitor for signs and symptoms of immune‑mediated adverse reactions. Evaluate clinical chemistries, including liver enzymes, creatinine, and thyroid function, at baseline and periodically during treatment. Withhold or permanently discontinue JEMPERLI and administer corticosteroids based on the severity of reaction. ( 2.3 , 5.1 ) • Infusion-related reactions: Interrupt, slow the rate of infusion, or permanently discontinue JEMPERLI based on severity of reaction. ( 2.3 , 5.2 ) • Complications of allogeneic hematopoietic stem cell transplantation (HSCT): Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after being treated with a PD‑1/PD-L1–blocking antibody. ( 5.3 ) • Embryo-fetal toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.

The following clinically significant adverse reactions are described elsewhere in the labeling: • Severe and fatal immune-mediated adverse reactions [see Warnings and Precautions ( 5.1 )] • Infusion-related reactions [see Warnings and Precautions ( 5.2 )] • Most common adverse reactions (≥20%), including laboratory abnormalities, with JEMPERLI in combination with carboplatin and paclitaxel in patients with EC are decreased hemoglobin, increased creatinine, peripheral neuropathy, decreased white blood cell count, fatigue, nausea, alopecia, decreased platelets, increased glucose, decreased lymphocytes, decreased magnesium, decreased neutrophils, increased aspartate aminotransferase (AST), arthralgia, rash, constipation, diarrhea, increased alanine aminotransferase (ALT), decreased potassium, decreased albumin, decreased sodium, increased alkaline phosphatase, abdominal pain, dyspnea, decreased appetite, increased amylase, decreased phosphate, urinary tract infection, and vomiting. ( 6.1 ) • Most common adverse reactions (≥20%) with JEMPERLI as a single agent in patients with dMMR solid tumors are fatigue/asthenia, anemia, diarrhea, and nausea. Most common Grade 3 or 4 laboratory abnormalities (≥2%) are decreased lymphocytes, decreased sodium, increased alkaline phosphatase, and decreased albumin. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Lactation: Advise not to breastfeed. ( 8.2 ) 8.1 Pregnancy Risk Summary Based on its mechanism of action, JEMPERLI can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] . There are no available data on the use of JEMPERLI in pregnant women. Animal studies have demonstrated that inhibition of the PD-1/PD-L1 pathway can lead to increased risk of immune-mediated rejection of the developing fetus resulting in fetal death (see ) . Human IgG4 immunoglobulins (IgG4) are known to cross the placental barrier; therefore, dostarlimab-gxly has the potential to be transmitted from the mother to the developing fetus. Advise women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data: Animal reproduction studies have not been conducted with JEMPERLI to evaluate its effect on reproduction and fetal development. A central function of the PD-1/PD-L1 pathway is to preserve pregnancy by maintaining maternal immune tolerance to the fetus.

Metabolism

The pharmacokinetics of dostarlimab-gxly as a single agent and in combination with carboplatin and paclitaxel were evaluated in patients with various solid tumors, including patients with EC. Mean C max , AUC 0-inf , and AUC 0-tau increased proportionally over the dose range of 1 to 10 mg/kg.

• Apr 22, 2021BLABLA761174Glaxosmithkline

1. 1Malignant Neoplasm Progression20410%
2. 2Off Label Use1175.8%
3. 3Rash994.9%
4. 4Anaemia874.3%
5. 5Fatigue854.2%
6. 6Thrombocytopenia753.7%
7. 7Death743.7%
8. 8Diarrhoea743.7%
9. 9Arthralgia663.3%
10. 10Neuropathy Peripheral592.9%
11. 11Pyrexia572.8%
12. 12Nausea532.6%
13. 13Hypothyroidism512.5%
14. 14Condition Aggravated502.5%
15. 15Product Use In Unapproved Indication472.3%

The 10 most recently updated of 103 ClinicalTrials.gov registrations naming Dostarlimab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Single Arm Study of Neoadjuvant Dostarlimab in Stage II and III Deficient Mismatch Repair Colon Cancers
  Recruiting · Phase 2 · Interventional · 25 enrolled · University of Iowa
  NCT05239546updated 2026-06-12
• Phase I Trial Testing the Safety and Tolerability of Chemoradiation Followed by Chemotherapy + Dostarlimab for Stage IIIC, Node Positive, Endometrial Cancer
  Recruiting · Phase 1 · Interventional · 21 enrolled · M.D. Anderson Cancer Center
  NCT05819892updated 2026-06-08
• Two-cohort Study of Niraparib and Dostarlimab Plus (Chemo)RadIotherapy in Locally-Advanced Head and Neck Squamous Cell Carcinoma
  Active not recruiting · Phase 1 · Phase 2 · Interventional · 34 enrolled · Grupo Español de Tratamiento de Tumores de Cabeza y Cuello
  NCT05784012updated 2026-06-04
• Recurrent Ovarian CarcinoSarcoma Anti-pd-1 Niraparib
  Recruiting · Phase 2 · Phase 3 · Interventional · 138 enrolled · ARCAGY/ GINECO GROUP
  NCT03651206updated 2026-06-01
• A Study of Dostarlimab vs Placebo After Chemoradiation in Adult Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma
  Recruiting · Phase 3 · Interventional · 864 enrolled · GlaxoSmithKline
  NCT06256588updated 2026-05-26
• A Study of Dostarlimab in Untreated dMMR/MSI-H Locally Advanced Rectal Cancer
  Active not recruiting · Phase 2 · Interventional · 154 enrolled · GlaxoSmithKline
  NCT05723562updated 2026-05-26
• First-Time-in-Human Study of GSK4381562 in Participants With Advanced Solid Tumors
  Active not recruiting · Phase 1 · Interventional · 152 enrolled · GlaxoSmithKline
  NCT05277051updated 2026-05-22
• A Study of Mocertatug Rezetecan in Combination With Anti-cancer Therapies for Advanced Solid Tumors
  Recruiting · Phase 1 · Phase 2 · Interventional · 305 enrolled · GlaxoSmithKline
  NCT06796907updated 2026-05-22
• A Study of Neoadjuvant Dostarlimab Plus Capecitabine Plus Oxaliplatin (CAPEOX) Vs CAPEOX With Previously Untreated T4N0 or Stage III Mismatch Repair Proficient (MMRp)/Microsatellite Stable (MSS) Colon Cancer
  Recruiting · Phase 2 · Interventional · 120 enrolled · GlaxoSmithKline
  NCT06567782updated 2026-05-22
• A Study of GSK5764227 in Participants With Advanced Solid Tumors (EMBOLD)
  Recruiting · Phase 1 · Interventional · 845 enrolled · GlaxoSmithKline
  NCT06551142updated 2026-05-22

Frequently asked questions

How does Dostarlimab work?

Binding of the PD-1 ligands, PD-L1 and PD-L2, to the PD-1 receptor found on T cells inhibits T-cell proliferation and cytokine production. Upregulation of PD-1 ligands occurs in some tumors, and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumors.

What is Dostarlimab used for?

According to FDA labeling, Dostarlimab carries indications including: JEMPERLI is a programmed death receptor-1 (PD-1)–blocking antibody indicated: Endometrial Cancer • in combination with carboplatin and paclitaxel, followed by JEMPERLI as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial cancer (EC). ( 1.1 ) • as a single agent for the treatment of adult patients with mismatch repair deficient (dMMR) recurrent or advanced EC, as determined by an FDA-approved test, that has progressed on or following prior treatment with a platinum-containing regimen in any setting and are not candidates for curative surgery or radiation.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Dostarlimab?

Dostarlimab is classified as PD-1/PD-L1 (Programmed cell death protein 1/death ligand 1) inhibitors, Programmed Death Receptor-1 Blocking Antibody, Antibody-Receptor Interactions, Programmed Death Receptor-1-directed Antibody Interactions.

What are the brand names for Dostarlimab?

Dostarlimab is marketed under brand names including Jemperli.

What are the contraindications for Dostarlimab?

Dostarlimab labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.