Dostarlimab is an anti-PD-1 monoclonal antibody used in the treatment of mismatch repair deficient endometrial cancers and solid tumours with no alternative treatment options.

Brand Names
Generic Name
DrugBank Accession Number

Dostarlimab is an IgG4 humanized monoclonal antibody targeted against the human programmed death receptor-1 (PD-1).6 PD-1 receptors are found on T-cells and, when activated, serve to inhibit immune responses - some cancers leverage this system by overexpressing PD-1 ligands, thereby effectively inhibiting the anti-tumor immune response that would typically attempt to destroy the cancerous cells.3 Agents acting on the PD-1 pathway, such as nivolumab and pembrolizumab, facilitate endogenous immune-mediated anti-tumor activity and may therefore be used to treat a wide variety of cancers, including those of the skin, lung, kidneys, and liver.

In April 2021, dostarlimab was granted accelerated approval by the FDA - as GlaxoSmithKline's dostarlimab-gxly (Jemperli) - for the treatment of adult patients with recurrent or advanced mismatch repair deficient (dMMR) endometrial cancer experiencing disease progression despite treatment with platinum-containing chemotherapy regimens.7 A companion diagnostic device - the VENTANA MMR RxDx Panel - was also approved alongside this indication to select appropriate patients for treatment.7 This indication was granted full FDA approval on February 10, 2023.10 Dostarlimab-gxly was granted second accelerated approval for the treatment of solid tumours in the same month.9

Dostarlimab is currently under investigation for the treatment of rectal cancers with mismatch repair deficiency. A prospective phase II study in patients with mismatch repair-deficient locally advanced rectal cancer resulted in all twelve patients exhibiting a complete clinical response.5

Approved, Investigational
Biologic Classification
Protein Based Therapies
Monoclonal antibody (mAb)
Protein Chemical Formula
Protein Average Weight
144000.0 Da (non-glycosylated)
>Heavy Chain
>Light Chain
  1. Statement on a Nonproprietary Name Adopted by the USAN Council: Dostarlimab [Link]
Download FASTA Format
  • Dostarlimab
  • dostarlimab-gxly
  • Immunoglobulin G4, anti-programmed cell death protein 1 (PDCD1) (humanized clone ABT1 gamma4-chain), disulfide with humanized clone ABT1 kappa-chain, dimer
External IDs
  • GSK-4057190
  • GSK4057190
  • TSR 042
  • TSR-042
  • WBP-285



Dostarlimab-gxly is indicated for the treatment of adult patients with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer that has progressed despite ongoing or prior treatment with a platinum-containing chemotherapy regimen.6

It is also indicated for the treatment of solid tumours in adults, as determined by an FDA-approved test, that have progressed on or following prior treatment and in patients who have no satisfactory alternative treatment options. This indication is approved under accelerated approval, and continued approval for this indication may be contingent upon verification and description of and description of clinical benefit in confirmatory trials.9

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Associated Conditions
Contraindications & Blackbox Warnings
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Dostarlimab is an immunotherapy that facilitates the body's endogenous anti-tumor immune response in the treatment cancer.6 It is administered over a span of 30 minutes via intravenous infusion every three to six weeks depending on the cycle.6

Agents that interfere with the PD-1/PD-L1 pathway, including dostarlimab, remove an important immune system inhibitory response and may therefore induce immune-mediated adverse reactions which can be severe or fatal. These reactions can occur in any organ system and can occur at any time after starting therapy, and while they most often manifest during therapy they may also appear after discontinuing the causative agent. Patients receiving therapy with dostarlimab should be monitored closely for evidence of an underlying immune-mediated reaction and evaluated and treated promptly if an immune-mediated reaction is suspected.6

Mechanism of action

Approximately 13-30% of recurrent endometrial cancers involve microsatellite instability (MSI) or mismatch repair deficiency (dMMR).3,4 The mutations resulting in dMMR endometrial cancers are primarily somatic in nature (~90%), although 5-10% of cases involve germline mutations.4 Cancers that have mutations resulting in dMMR can upregulate the expression of programmed death receptor-1 (PD-1) ligands 1 and 2 (PD-L1 and -L2) - PD-1 is found on T-cells and, when activated, inhibits their proliferation and the production of cytokines.6 The binding of these ligands to PD-1 thereby functions as an immune checkpoint that downregulates the anti-tumor immune response.3

Dostarlimab is a monoclonal antibody targeted against PD-1 - it binds to the receptor and prevents interactions with PD-L1 and PD-L2, thus allowing the anti-tumor immune response to proceed unimpeded.6

AProgrammed cell death protein 1

During the first cycle, and administered at 500mg intravenously every 3 weeks, the mean Cmax and AUC0-tau of dostarlimab-gxly are 171 mcg/mL and 35,730 mcg.h/mL, respectively. When administered at 1000mg every 6 weeks, the mean Cmax and AUC0-tau are 309 mcg/mL and 95,820 mcg.h/mL, respectively.6

Volume of distribution

At steady-state, the mean volume of distribution of dostarlimab is 5.3L.6

Protein binding

Not Available


The metabolism of dostarlimab has not been characterized, but it is expected to be degraded via catabolic pathways into smaller peptides and amino acids.6,2

Route of elimination

Not Available


The mean terminal elimination half-life of dostarlimab is 25.4 days.6


At steady-state, the mean clearance of dostarlimab is 0.007 L/h.6

Adverse Effects
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There are no data regarding overdose with dostarlimab. Symptoms of overdosage are likely to be consistent with the adverse effect profile of dostarlimab and may therefore involve significant immune-mediated reactions.6

Not Available
Pharmacogenomic Effects/ADRs
Not Available


Drug Interactions
This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
AbciximabThe risk or severity of adverse effects can be increased when Abciximab is combined with Dostarlimab.
AdalimumabThe risk or severity of adverse effects can be increased when Adalimumab is combined with Dostarlimab.
AducanumabThe risk or severity of adverse effects can be increased when Aducanumab is combined with Dostarlimab.
AlemtuzumabThe risk or severity of adverse effects can be increased when Alemtuzumab is combined with Dostarlimab.
AlirocumabThe risk or severity of adverse effects can be increased when Alirocumab is combined with Dostarlimab.
AmbroxolThe risk or severity of methemoglobinemia can be increased when Dostarlimab is combined with Ambroxol.
AmivantamabThe risk or severity of adverse effects can be increased when Dostarlimab is combined with Amivantamab.
AnifrolumabThe risk or severity of adverse effects can be increased when Anifrolumab is combined with Dostarlimab.
AnsuvimabThe risk or severity of adverse effects can be increased when Dostarlimab is combined with Ansuvimab.
Anthrax immune globulin humanThe risk or severity of adverse effects can be increased when Anthrax immune globulin human is combined with Dostarlimab.
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Food Interactions
No interactions found.


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International/Other Brands
Jemperli (GlaxoSmithKline)
Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
JemperliSolution50 mg / mLIntravenousGlaxosmithkline Inc2022-02-22Not applicableCanada flag
JemperliInjection50 mg/1mLIntravenousGlaxoSmithKline LLC2021-04-22Not applicableUS flag
JemperliInjection, solution, concentrate500 mgIntravenousGlaxo Smith Kline (Ireland) Limited2022-06-06Not applicableEU flag


ATC Codes
L01FF07 — Dostarlimab
Drug Categories
Chemical TaxonomyProvided by Classyfire
Not Available
Organic Compounds
Super Class
Organic Acids
Carboxylic Acids and Derivatives
Sub Class
Amino Acids, Peptides, and Analogues
Direct Parent
Alternative Parents
Not Available
Not Available
Molecular Framework
Not Available
External Descriptors
Not Available
Affected organisms
  • Humans and other mammals

Chemical Identifiers

CAS number


General References
  1. Kaplon H, Muralidharan M, Schneider Z, Reichert JM: Antibodies to watch in 2020. MAbs. 2020 Jan-Dec;12(1):1703531. doi: 10.1080/19420862.2019.1703531. [Article]
  2. Temrikar ZH, Suryawanshi S, Meibohm B: Pharmacokinetics and Clinical Pharmacology of Monoclonal Antibodies in Pediatric Patients. Paediatr Drugs. 2020 Apr;22(2):199-216. doi: 10.1007/s40272-020-00382-7. [Article]
  3. Green AK, Feinberg J, Makker V: A Review of Immune Checkpoint Blockade Therapy in Endometrial Cancer. Am Soc Clin Oncol Educ Book. 2020 Mar;40:1-7. doi: 10.1200/EDBK_280503. [Article]
  4. Deshpande M, Romanski PA, Rosenwaks Z, Gerhardt J: Gynecological Cancers Caused by Deficient Mismatch Repair and Microsatellite Instability. Cancers (Basel). 2020 Nov 10;12(11). pii: cancers12113319. doi: 10.3390/cancers12113319. [Article]
  5. Cercek A, Lumish M, Sinopoli J, Weiss J, Shia J, Lamendola-Essel M, El Dika IH, Segal N, Shcherba M, Sugarman R, Stadler Z, Yaeger R, Smith JJ, Rousseau B, Argiles G, Patel M, Desai A, Saltz LB, Widmar M, Iyer K, Zhang J, Gianino N, Crane C, Romesser PB, Pappou EP, Paty P, Garcia-Aguilar J, Gonen M, Gollub M, Weiser MR, Schalper KA, Diaz LA Jr: PD-1 Blockade in Mismatch Repair-Deficient, Locally Advanced Rectal Cancer. N Engl J Med. 2022 Jun 5. doi: 10.1056/NEJMoa2201445. [Article]
  6. FDA Approved Drug Products: Jemperli (dostarlimab-gxly) for intravenous injection [Link]
  7. FDA News Release: FDA grants accelerated approval to dostarlimab-gxly for dMMR endometrial cancer [Link]
  8. Statement on a Nonproprietary Name Adopted by the USAN Council: Dostarlimab [Link]
  9. FDA Approved Drug Products: JEMPERLI (dostarlimab-gxly) injection, for intravenous use (February 2023) [Link]
  10. BioSpace: US FDA grants regular approval for Jemperli for the treatment of patients with recurrent or advanced mismatch repair-deficient endometrial cancer [Link]
  11. FDA Approved Drug Products: JEMPERLI (dostarlimab-gxly) injection, for intravenous use (July 2023) [Link]

Clinical Trials

Clinical Trials
3Active Not RecruitingTreatmentNeoplasm1
3Active Not RecruitingTreatmentOvarian Neoplasms / Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma1
3RecruitingTreatmentColon Neoplasm / Neoplasms, Colon1
3RecruitingTreatmentEndometrial Cancer1
3RecruitingTreatmentOvarian Cancer1
3WithdrawnTreatmentOvarian Cancer1
2Active Not RecruitingTreatmentAdvanced Malignant Neoplasm / Cervical Cancer1
2Active Not RecruitingTreatmentEndometrial Cancer1
2Active Not RecruitingTreatmentHead And Neck Cancer1
2Active Not RecruitingTreatmentMalignant Pleural Mesothelioma (MPM)1


Not Available
Not Available
Dosage Forms
InjectionIntravenous50 mg/1mL
Injection, solutionIntravenous500 MG
Injection, solution, concentrateIntravenous500 mg
SolutionIntravenous50 mg / mL
Not Available
Not Available


Experimental Properties
Not Available


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Pharmacological action
General Function
Signal transducer activity
Specific Function
Inhibitory cell surface receptor involved in the regulation of T-cell function during immunity and tolerance. Upon ligand binding, inhibits T-cell effector functions in an antigen-specific manner. ...
Gene Name
Uniprot ID
Uniprot Name
Programmed cell death protein 1
Molecular Weight
31646.635 Da
  1. FDA Approved Drug Products: Jemperli (dostarlimab-gxly) for intravenous injection [Link]

Drug created at March 07, 2020 19:58 / Updated at August 01, 2023 19:26