Drug updated on 4/17/2024
| Dosage Form | Injection (intravenous; 500 mg/10 mL (50 mg/mL)) |
| Drug Class | Programmed death receptor-1 (PD-1) blocking antibodies |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated 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 that is mismatch repair deficient (dMMR), as determined by an FDA-approved test, or microsatellite instability-high (MSI-H).
- Indicated as a single agent for the treatment of adult patients with dMMR recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following prior treatment with a platinumcontaining regimen in any setting and are not candidates for curative surgery or radiation.
- Indicated as a single agent for the treatment of adult patients with dMMR recurrent or advanced solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options.
Summary
- Dostarlimab-gxly (Jemperli) is indicated for use 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 that is mismatch repair deficient (dMMR), as determined by an FDA-approved test, or microsatellite instability-high (MSI-H).
- Additionally, dostarlimab-gxly (Jemperli) can be used alone to treat adult patients with dMMR recurrent or advanced endometrial cancer that has progressed on prior platinum-containing regimen treatments and are not candidates for curative surgery or radiation.
- The drug also serves as a standalone treatment option for adults suffering from dMMR recurrent or advanced solid tumors which have worsened following previous treatments when no satisfactory alternative options exist.
- A systematic review/meta-analysis was conducted on population pharmacokinetic models of anti-PD-1 monoclonal antibodies including dostarlimab-gxly(Jemperli). This study provides insights into the effects of covariates such as body weight, albumin levels, tumor type sex and performance status on PK parameters.
- The study reviewed falls under the category "Systematic Reviews / Meta-Analyses" providing valuable information about how this drug compares to other drugs in terms of safety and effectiveness.
- It should be noted that less frequently assessed but significant covariates like lactate dehydrogenase (LDH), immunoglobulin G (IgG), ipilimumab coadministration (IPICO) were identified during this research process indicating further investigation needed to assess new potential covariates paving way towards personalized anti-PD-1 mAbs therapy using drugs like dostarlimab-gxly (Jemperli).
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Jemperli (dostarlimab-gxly) Prescribing Information. | 2023 | GlaxoSmithKline LLC, Philadelphia, PA |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Biomarkers for systemic therapy in metastatic breast cancer: ASCO guideline update. | 2022 | Journal of Clinical Oncology |