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)
ICD-10 codes (AIS) C54.1Malignant neoplasm of endometrium
Alpha-ID codes (AIS) I27788Endometrial carcinoma
DDD 24 mg P
Therapeutic area Oncological diseases Endometrial cancer (EC)
Reason for procedure Initial assessment
Regulatory status Conditional Approval
Specialty ACT change

Therapeutic indication of the resolution

JEMPERLI is indicated as monotherapy for the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer (EC) that has progressed on or following prior treatment with a platinum-containing regimen.
Subpopulation Indication Comparator
Adult patients with recurrent or advanced endometrial cancer (EC) with dMMR/ MSI-H who experience disease progression during or after a platinum-based regimen. Therapy according to physician's choice

Studies and Results

No. of studies
(best subpopulation) 		1 (GARNET) 0 (Data not accepted)
Study design
(best subpopulation) 		Data not accepted (Dossier: Single-arm + historical comparison)
ACT change 01.11.2021 – Stellungnahmeverfahren, Ergänzung Paclitaxel

  • 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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