Susana Banerjee, MBBS, PhD, discusses the significance of the long-term results of the MEDIOLA trial of patients with 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 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 BRCA-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 BRCA mutation. That study is being performed by the European Network of Gynaecological Oncological Trial Groups (ENGOT) and GOG Foundation.
0:08 | 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.