Drug updated on 9/4/2024
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 (EC).
- Indicated 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.
- 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.
Latest News
Summary
- Jemperli (dostarlimab-gxly) is 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 (EC); indicated 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; 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.
- This summary is based on the review of six systematic reviews/meta-analyses. [1-6]
- Survival Outcomes: Dostarlimab combined with chemotherapy significantly improved progression-free survival (PFS) in the overall population (pooled HR, 0.63; 95% CI, 0.52-0.76; P < .001). This combination was particularly effective in patients with mismatch repair-deficient/microsatellite instability-high (dMMR/MSI-H) tumors, showing substantial benefits in both PFS and overall survival (OS) compared to other immunotherapy regimens and standard chemotherapy.
- Objective Response Rate (ORR): Among patients with advanced or recurrent endometrial cancer, those with dMMR had a notably higher ORR of 51.9% compared to 16.1% in patients with mismatch repair-proficient (pMMR) tumors when treated with PD-1/PD-L1 inhibitors, including dostarlimab.
- Effectiveness in Specific Populations: Dostarlimab demonstrated significant effectiveness in the dMMR/MSI-H population, with marked improvements in PFS and OS. However, its benefit in the pMMR subgroup was limited to PFS, with no significant improvement in OS.
- Adverse Events (AEs): In combination treatments involving immune checkpoint inhibitors (ICIs) like dostarlimab with chemotherapy, treatment-related adverse events (TRAEs) occurred in 54.2% to 76% of patients. The combination of ICIs with tyrosine-kinase inhibitors (TKIs) showed higher toxicity rates, with ≥G3 TRAEs reported in 88.9% of patients.
- Specific Safety Concerns: The combination of ICIs with TKIs demonstrated higher toxicity, which may be particularly concerning for patients with comorbid conditions or poor performance status.
- Subgroup Findings: Dostarlimab, particularly when combined with chemotherapy, demonstrated significant survival benefits and higher objective response rates (ORR) in patients with mismatch repair-deficient/microsatellite instability-high (dMMR/MSI-H) tumors, with ORRs reaching 51.9%. However, its effectiveness was notably lower in patients with mismatch repair-proficient (pMMR) tumors. No significant differences in effectiveness or safety were explicitly reported for other demographic or clinical subgroups beyond mismatch repair status.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Jemperli (dostarlimab-gxly) Prescribing Information. | 2024 | GlaxoSmithKline LLC, Philadelphia, PA |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Endometrial carcinoma. NCCN clinical practice guidelines in oncology. Uterine neoplasms. Version 2.2024. March 6, 2024 | 2024 | NCCN Clinical Practice Guidelines in Oncology |
Practice guidelines for management of uterine corpus cancer in Korea: a Korean Society of Gynecologic Oncology consensus statement. | 2024 | Journal of Gynecologic Oncology |
The Polish Society of Gynecological Oncology Guidelines for the Diagnosis and Treatment of Endometrial Carcinoma (2023). | 2023 | Journal of Clinical Medicine |
Endometrial cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. | 2022 | Annals of Oncology |
SEOM-GEICO clinical guidelines on endometrial cancer (2021). | 2022 | Clinical and Translational Oncology |
Biomarkers for systemic therapy in metastatic breast cancer: ASCO guideline update. | 2022 | Journal of Clinical Oncology |