Favourable opinion for reimbursement in the following indication: “IMFINZI in combinatiowith platinum-based chemotherapy, followed by IMFINZI as monotherapy, is indicated for the first-line treatment of adults with advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR).”
Clinical Benefit
Substantial
The Committee deems that the clinical benefit of IMFINZI (durvalumab) concentrate for solution for infusion is substantial in the MA indications.
Clinical Added Value
minor
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).
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