Summary

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• 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.