Susana Banerjee, MBBS, PhD, discusses the updated results of the MEDIOLA trial of patients with ovarian cancer presented at the 2022 European Society for Medical Oncology Congress.
Susana Banerjee, MBBS, PhD, a consultant medical oncologist and research lead for the gynecology unit at The Royal Marsden NHS Foundation Trust, discusses the updated results of the MEDIOLA trial (NCT02734004) of patients with ovarian cancer presented at the 2022 European Society for Medical Oncology (ESMO) Congress.
The phase 1/2 MEDIOLA trial enrolled patients with relapsed non–germline BRCA-mutated platinum-sensitive ovarian cancer; 32 of whom received doublet olaparib (Lynparza) and durvalumab (Imfinzi), and 31 of whom received triplet olaparib, durvalumab, and bevacizumab (Avastin). Previous results showed an objective response rate (ORR) of 34% and median progression-free survival (PFS) of 5.5 months with the doublet, and an ORR of 87% and median PFS of 14.7 months for the triplet combination.
The updated results included a final analysis of overall survival (OS) and disease control rate (DCR) at 56 weeks. In the patients who received the triplet combination, median OS was 31.9 months and the DCR was 38.7%, whereas for the doublet median OS was 26.1 months and DCR was 9.4%. These data demonstrate continued efficacy for both the doublet and triplet combinations in patients with relapsed ovarian cancer with a BRCA mutation who previously responded to chemotherapy.
0:08 | MEDIOLA is a phase 2 study, and it was designed to evaluate combined treatments with the PARP inhibitor olaparib plus the PD-L1 inhibitor durvalumab, in women with platinum-sensitive relapsed ovarian cancer. And the latest update is of a triplet combination of olaparib plus durvalumab and the anti-angiogenic agent bevacizumab. We also updated the combination, the doublet of olaparib plus durvalumab. And this was specifically in women without a germline BRCA mutation.
Now, we already knew from our presentation back in 2020, at the ESMO Congress, that the response rate was around 34%, and median PFS was just over 5 and a half months with a doublet combination. And with the triplet that's really showed promising efficacy with a response rate of 87%, and a median PFS of 14.7 [months].
1:12 | What I updated in terms of the MEDIOLA study at the ESMO Congress 2022 was the OS and the DCR at 56 weeks. And what we saw was that in the triplet cohort, the median OS was almost 32 months, 31.9 months, and the 56-week DCR was almost 39%. Now in the doublet cohort of olaparib plus durvalumab, the median OS was  months, and the 56-week DCR was around 9%.