Dostarlimab (3) – Jemperli®

Primarily advanced or recurrent endometrial cancer with pMMR, combination with carboplatin and paclitaxel

Characteristics

Start date 15.02.2025 – Marketing authorisation: 15.01.2025
Resolution 07.08.2025
INN Dostarlimab
Brand name Jemperli®
Pharm. company GlaxoSmithKline GmbH & Co. KG
G-BA Procedure ID D-1155
ATC code L01FF07 PD-1/PDL-1 inhibitors (L01FF)
ICD-10 codes (AIS) C54.1Malignant neoplasm of endometrium
Alpha-ID codes (AIS) I27788Endometrial carcinoma
Therapeutic area Oncological diseases Endometrial cancer (EC)
Reason for procedure New therapeutic indication
Specialty ACT change

Therapeutic indication of the resolution

Jemperli is indicated in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with primary advanced or recurrent endometrial cancer with mismatch repair failure (pMMR) who are candidates for systemic therapy.
Subpopulation Indication Comparator
Adult patients with primary advanced endometrial carcinoma (stage III or IV) or with recurrence of endometrial carcinoma with mismatch repair failure (pMMR) who have not yet received systemic therapy for the treatment of – have not yet received systemic therapy as postoperative or adjuvant therapy for the treatment of the primary advanced disease, – have not yet received chemotherapy for the recurrence Durvalumab in combination with carboplatin and paclitaxel, followed by durvalumab in combination with olaparib

Studies and Results

No. of studies
(best subpopulation) 		1 (RUBY) 0 (Data not accepted)
Study design
(best subpopulation) 		Data not accepted (Dossier: H2H vs. non-ACT + no ITC)
ACT change 25.02.2025 – Neuer Therapiestandard

  • Clinical trials
    • The Ruby trial is an ongoing, multicentre, double-blind, randomised controlled Phase IIItrial, in which dostarlimab in combination with carboplatin and paclitaxel, followed by dostarlimab, is compared with placebo in combination with carboplatin and paclitaxel, followed by placebo.

Adult female patients with primary advanced endometrial cancer (stage III or IV) or with recurrent endometrial carcinoma with mismatch repair proficiency (pMMR), who have not previously received systemic therapy as postoperative or adjuvant treatment for − their primary advanced disease, − have not yet received chemotherapy for the recurrence

  • The conclusion is that, for dostarlimab in combination with carboplatin and paclitaxel followed by dostarlimab as first-line treatment for primary advanced or recurrent endometrial cancer in adult female patients with pMMR who are suitable for systemic therapy, an additional benefit is not proven.
  • The additional benefit is not proven.
  • Reasoning:
  • The comparator arm of the study therefore does not correspond to the appropriate comparator therapy. Consequently, no suitable data are available.
  • Overall assessment
    • It is concluded that for dostarlimab in combination with carboplatin and paclitaxel, followed by dostarlimab, as first-line treatment for primary advanced or recurrent endometrial cancer in adult female patients with pMMR who are suitable for systemic therapy, an additional benefit is not proven.

Courtesy translation only, please refer to the German original.

Associated procedures



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