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JEMPERLI (DOSTARLIMAB-GXLY)
JEMPERLI (generic name: DOSTARLIMAB-GXLY) is a Programmed Death Receptor-1 Blocking Antibody [EPC] drug developed by GLAXOSMITHKLINE. It is currently FDA-approved for Endometrial Cancer - Combination Therapy, Endometrial Cancer - Single Agent, Mismatch Repair Deficient Recurrent or Advanced Solid Tumors.
Dostarlimab-gxly blocks PD-1 receptor interaction with PD-L1 and PD-L2, enhancing anti-tumor immune response.
Jemperli is a programmed cell death protein 1 antagonist, a type of antibody that targets the programmed cell death protein 1. It is being studied in combination with niraparib and short course radiation for the treatment of rectal cancers, as well as other conditions such as recurrent endometrial serous adenocarcinoma.
At a glance
| Generic name | DOSTARLIMAB-GXLY |
|---|---|
| Sponsor | GLAXOSMITHKLINE |
| Drug class | Programmed Death Receptor-1 Blocking Antibody [EPC] |
| Target | PD-1 |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Mechanism of action
Dostarlimab-gxly is designed to bind to the PD-1 receptor on T cells, preventing it from interacting with its ligands PD-L1 and PD-L2. This action releases the inhibition on T-cell activity, allowing the immune system to more effectively recognize and attack tumor cells.
Approved indications
- Endometrial Cancer - Combination Therapy
- Endometrial Cancer - Single Agent
- Mismatch Repair Deficient Recurrent or Advanced Solid Tumors
Common side effects
- Decreased hemoglobin
- Increased creatinine
- Peripheral neuropathy
- Decreased white blood cell count
- Fatigue
- Nausea
- Alopecia
- Decreased platelets
- Increased glucose
- Decreased lymphocytes
- Decreased magnesium
- Decreased neutrophils
Serious adverse events
- Serious adverse reactions (overall)
- Sepsis/urosepsis
- Pulmonary embolism
- Fatal adverse reactions
- Septic shock
- Myelosuppression
- Rash maculo-papular (discontinuation)
- Pancreatitis (discontinuation)
- Pneumonitis (discontinuation)
Key clinical trials
- A Phase 2, Single-Arm, Open-Label Study With Dostarlimab Monotherapy in Participants With Untreated Stage II/III dMMR/MSI-H Locally Advanced Rectal Cancer (Phase 2)
- A Phase 2 Study of the Combination Dostarlimab With Niraparib In Patients With Penile Carcinoma Who Have Progressed Following Chemotherapy (Phase 2)
- A Phase 3, Open-Label, Randomized Study of Perioperative Dostarlimab Monotherapy Versus Standard of Care in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer (Phase 3)
- Early Phase II Exploratory, Open-Label, Non-Randomized Study of Neoadjuvant Dostarlimab Monotherapy in Participants With Untreated T3-4N0-2 or Stage III pMMR/MSS Resectable Colon Cancer (Phase 2)
- A Phase 1b/2 Trial of Preoperative Niraparib, Dostarlimab, and Hypofractionated Radiotherapy for the Treatment of Locally-advanced Rectal Cancers. (Phase 1)
- Phase II Trial of Combination Niraparib and Dostarlimab Therapy for Recurrent or Persistent Uterine Serous Carcinoma (Phase 2)
- Short-Term Fasting Prior to Standard Checkpoint Blockade Using PD-1/PD-L1 Inhibition: A Pilot Safety and Feasibility Study (Phase 1)
- A Three-arm Randomized Phase II Study of Dostarlimab Alone or With Bevacizumab Versus Nonplatinum Chemotherapy in Recurrent Gynecological Clear Cell Carcinoma: DOVE (APGOT-OV07/ ENGOT-ov80 Study) (Phase 2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- JEMPERLI CI brief — competitive landscape report
- JEMPERLI updates RSS · CI watch RSS
- GLAXOSMITHKLINE portfolio CI
Frequently asked questions about JEMPERLI
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Related
- Drug class: All Programmed Death Receptor-1 Blocking Antibody [EPC] drugs
- Target: All drugs targeting PD-1
- Manufacturer: GLAXOSMITHKLINE — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Endometrial Cancer - Combination Therapy
- Indication: Drugs for Endometrial Cancer - Single Agent
- Indication: Drugs for Mismatch Repair Deficient Recurrent or Advanced Solid Tumors
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing