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Dostarlimab-gxly

(Jemperli®)

Dostarlimab-gxly

Drug updated on 12/11/2024

Dosage FormInjection (intravenous; 500 mg/10 mL [50 mg/mL])
Drug ClassProgrammed death receptor-1 (PD-1) blocking antibodies
Ongoing and
Completed Studies		ClinicalTrials.gov

Indication

  • Indicated for the treatment of adult patients with primary advanced or recurrent endometrial cancer (EC), in combination with carboplatin and paclitaxel, followed by JEMPERLI
  • as a single agent
  • Indicated as a single agent for the treatment of adult patients with mismatch repair deficient (dMMR) recurrent or advanced EC, as determined by an FDAapproved 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

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Summary
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  • This summary is based on the review of four systematic review(s)/meta-analysis(es). [1-4]
  • The addition of immune checkpoint inhibitors (ICIs) to chemotherapy significantly improved progression-free survival (PFS) in advanced endometrial cancer patients, with a pooled hazard ratio (HR) of 0.63 (95% confidence interval (CI), 0.52-0.76) in the overall population, and a greater benefit in deficient DNA (ctDNA) mismatch repair (dMMR) patients (pooled HR, 0.34; 95% CI, 0.27-0.44).
  • For proficient DNA mismatch repair (pMMR) patients, PFS improvement was significant only when anti-PD1 (pembrolizumab, nivolumab, dostarlimab) agents were used (HR 0.64; 95% CI, 0.46-0.90), while anti-programmed cell death ligand 1 (PD-L1) (avelumab, atezolizumab, durvalumab) agents did not show a statistically significant benefit (HR 0.87; 95% CI, 0.73-1.03).
  • Overall response rates (ORR) for single-agent anti-PD1 and anti-PD-L1 therapies ranged from 26.7% to 58% in microsatellite instability (MSI) patients and from 3% to 26.7% in microsatellite stable (MSS) patients, with combinations of ICIs and tyrosine kinase inhibitors (TKIs) showing ORRs of 32% to 63.6% in all-comers.
  • Treatment-related adverse events (TRAEs) were reported in 54.2% to 76% of patients, with the combination of ICIs and TKIs showing a higher toxicity rate, with grade ≥3 TRAEs reaching 88.9%.
  • Single-agent ICIs, such as pembrolizumab, nivolumab, and dostarlimab, had a lower incidence of severe TRAEs compared to combination therapies with TKIs, which demonstrated a higher overall toxicity profile.
  • In advanced endometrial cancer, patients with dMMR benefit significantly from both anti-PD1 and anti-PD-L1 agents, while pMMR patients only show a significant benefit when treated with anti-PD1 agents. Microsatellite instability (MSI) patients have higher ORRs and disease control rates (DCRs) with single-agent ICIs compared to MSS patients, with MSS patients showing greater benefit from the combination of ICIs with TKIs.