Dostarlimab (1) – Jemperli®

Endometrial carcinoma (EC), after platinum-based therapy

Characteristics

Start date 15.06.2021 – Marketing authorisation: 21.04.2021
Resolution 02.12.2021
INN Dostarlimab
Brand name Jemperli®
Pharm. company GlaxoSmithKline GmbH & Co. KG
G-BA Procedure ID D-699
ATC code L01FF07 PD-1/PDL-1 inhibitors (L01FF)
DDD 24 mg P
Therapeutic area Oncological diseases
Reason for procedure Initial assessment
Regulatory status Conditional Approval
Specialty ACT change

Studies and Results

  • Clinical trials
    • The GARNET trial is an ongoing, single-arm Phase I trial.
    • The ZoptEC trial is a completed randomised, controlled, open-label Phase III trial in which doxorubicin was compared with zoptarelin.

Adult female patients with recurrent or advanced endometrial carcinoma with dMMR/MSI-H in whom disease progression occurs during or after a platinum-based regimen

  • An additional benefit is not proven.
  • Overall, the data presented are not sufficient to demonstrate additional benefit compared with the appropriate comparator therapy; therefore, the additional benefit of dostarlimab as monotherapy in adult female patients with recurrent or advanced endometrial carcinoma with dMMR/MSI-H, in whom disease progression occurs during or after a platinum-based regimen, is not proven.
  • mortality
    • Patient-relevant secondary endpoints are assessed in the categories of overall survival, morbidity and health-related quality of life.
    • The results from the GARNET study alone are not suitable for assessing the additional benefit of dostarlimab, as they do not allow for a comparison with the appropriate comparator therapy.
  • morbidity
    • Patient-relevant secondary endpoints are assessed in the categories of overall survival, morbidity and health-related quality of life.
    • The primary endpoints of the study are those in the ‘side effects’ category, as well as the endpoints ‘objective response rate’ and ‘duration of response’.
  • Health-related quality of life
    • Patient-relevant secondary endpoints are assessed in the categories of overall survival, morbidity and health-related quality of life.
  • Side effects
    • The primary endpoints of the study are those in the ‘side effects’ category, as well as the objective response rate and duration of response.
  • Conclusion
    • Overall, the data presented are not sufficient to demonstrate additional benefit compared with the appropriate comparator therapy; therefore, the additional benefit of dostarlimab as monotherapy in adult female patients with recurrent or advanced endometrial carcinoma with dMMR/ MSI-H, in whom disease progression occurs during or after a platinum-based regimen, is not proven.
    • Dostarlimab may represent a relevant treatment option in individual cases within this therapeutic indication.

Courtesy translation only, please refer to the German original.

Associated procedures



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