Dostarlimab (3) – Jemperli®

• 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.