Overview
Dostarlimab is an IgG humanized monoclonal antibody targeted against the human programmed death receptor-1 (PD-1). 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. 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. A companion diagnostic device - the VENTANA MMR RxDx Panel - was also approved alongside this indication to select appropriate patients for treatment. This indication was granted full FDA approval on February 10, 2023. Dostarlimab-gxly was granted second accelerated approval for the treatment of solid tumours in the same month. 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.
Indication
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. 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.
Associated Conditions
- Advanced Microsatellite Instability High Endometrial Carcinoma
- Advanced Mismatch Repair-deficient (dMMR) Endometrial Cancer
- Advanced Mismatch repair deficient (dMMR) solid tumors
- Recurrent Microsatellite Instability (MSI)-High Endometrial Cancer
- Recurrent Mismatch Repair-deficient (dMMR) Endometrial Cancer
- Recurrent Mismatch repair deficient (dMMR) solid tumors
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2020/12/22 | Phase 3 | Recruiting | |||
2020/12/17 | Phase 1 | Active, not recruiting | |||
2020/12/07 | Phase 3 | Active, not recruiting | |||
2020/10/12 | Phase 2 | Active, not recruiting | |||
2020/10/09 | Phase 2 | Terminated | |||
2020/09/10 | Phase 1 | Terminated | |||
2020/07/30 | Phase 2 | Active, not recruiting | |||
2020/06/24 | Phase 1 | Active, not recruiting | |||
2020/06/01 | Phase 2 | Completed | |||
2020/03/18 | Phase 2 | Active, not recruiting | Trisha Wise-Draper |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
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| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
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HSA Drug Approvals
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NMPA Drug Approvals
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PPB Drug Approvals
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TGA Drug Approvals
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