IMFINZI (durvalumab) - Endometrial cancer

The Committee deems that the clinical benefit of IMFINZI (durvalumab) concentrate for solution for infusion is substantial in the MA indications.

Considering:

• evidence of a superiority in the phase 3 DUO-E study of durvalumab in combination with paclitaxel + carboplatin chemotherapy in the induction phase, followed by maintenance therapy with durvalumab as monotherapy in terms of radiological progression-free survival in the ITT population with an HRBvsA= 0.71 (CI95% = [0.57; 0.89]; p = 0.003). The median progression-free survival was 10.2 months (CI95% = [9.7; 14.7]) in the durvalumab group versus6 months, (CI95% = [9.0; 9.9]) in the control group, i.e. an absolute difference of 0.6 months;

and despite:

• the lack of evidence of a superiority of durvalumab in combination with paclitaxel + carboplatin chemotherapy in the induction phase, followed by maintenance therapy with durvalumab in combination with olaparib, in terms of overall survival, in the ITT population (including 20% dMMR/MSI-H patients) assessed via an interim analysis;
• the absence of an overall survival analysis specifically scheduled in the protocol for the dMMR/MSI-H patient subgroup in the DUO-E study;
• an excess toxicity compared to the other groups concerning grade 3 or 4 AEs, which are
  reported in around 50% of patients (primarily anaemia and neutropenia, but also syncope and gastrointestinal disorders);
• the absence of any formal conclusion that can be drawn on quality of life (exploratory endpoint);

the Committee deems that IMFINZI (durvalumab) concentrate for solution for infusion provides a minor clinical added value (CAV IV) compared to the carboplatin + paclitaxel combination in the treatment of adult patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer (EC).