Susana Banerjee, MBBS, PhD

Susana Banerjee, MBBS, PhD, a consultant medical oncologist and research lead for the gynecology unit at The Royal Marsden NHS Foundation Trust, discusses the significance of the long-term results of the MEDIOLA trial (NCT02734004) of patients with ovarian cancer presented at the 2022 European Society for Medical Oncology Congress.

This phase 1/2 trial investigated the combinations of olaparib (Lynparza) and durvalumab (Imfinzi) as well as olaparib, durvalumab, and bevacizumab (Avastin) in patients with recurrent non-germline 

-mutated platinum-sensitive ovarian cancer. While the trial demonstrated efficacy for the doublet and triplet regimens, Banerjee says that it was also important to learn that there were no unexpected safety signals or additive toxicity from the combinations.

She says that the trial also demonstrated that signals of clinical activity seen in early trials can be valuable for planning further clinical trials such as phase 3 trials of these doublet and triplet combinations. The combination of olaparib, durvalumab, and bevacizumab is being investigated in the ongoing phase 3 DUO-O trial (NCT03737643) as a maintenance regimen for patients with no 

 mutation. That study is being performed by the European Network of Gynaecological Oncological Trial Groups (ENGOT) and GOG Foundation.

 An important aspect we're looking at [with] combination treatments is also the safety. And what we learned with the long-term follow-up is that the safety profile was consistent with a known safety profile of the single agents. But the real implications of this treatment—I think it shows proof of concepts looking at signals, which is really important in earlier phase studies to see if there's some clinical activity, which is important to take forward in further clinical trials. That's what I think MEDIOLA brings to the table, looking at [the] combination of PARP inhibitors with immunotherapy and also the triplet combination with anti-angiogenic treatments. The next step is that the olaparib plus durvalumab and bevacizumab combination is actually under investigation, in the first-line setting of newly diagnosed advanced ovarian cancer as a maintenance treatment in patients with non­–BRCA-mutated advanced ovarian cancer. And that's in the phase 3 DUO-O study, [an] ENGOT and GOG study.

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Susana Banerjee, MBBS, PhD, discusses the significance of the long-term results of the MEDIOLA trial of patients with ovarian cancer.

Implications of the MEDIOLA Trial Results in Relapsed Ovarian Cancer

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 

-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 

 mutation who previously responded to chemotherapy.

 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 

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].

 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 [26] months, and the 56-week DCR was around 9%.

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 | Authors

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Implications of the MEDIOLA Trial Results in Relapsed Ovarian Cancer

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