At the 2020 European Society for Medical Oncology (ESMO) virtual congress, researchers presented results for safety and efficacy of olaparib plus durvalumab with or without bevacizumab in women with recurrent platinum-sensitive relapsed ovarian cancer who don't have a germline BRCA mutation.
In this exclusive ֱ video, study author , from Northern Center for Cancer Care in Newcastle upon Tyne, England, discusses the updated data.
Following is a transcript of her remarks:
So I had the privilege of presenting updated results from the MEDIOLA phase II trial of two new cohorts, where we're investigating the safety and efficacy of olaparib plus durvalumab with or without bevacizumab in women with recurrent platinum-sensitive relapsed ovarian cancer who don't have a germline BRCA mutation. We results of the doublet cohort of olaparib and durvalumab in women with germline BRCA mutations. But this was a cohort of triplets of olaparib, durvalumab, and bevacizumab, and then the doublet olaparib and durvalumab in the non-germline BRCA population.
And I think there's two real key results from the study that have come out. I think the first thing to say, this is a chemotherapy sparing treatment. This is not a maintenance treatment. This is for women with recurrent disease who need a treatment who have progressed on their previous treatment line.
So the key results are the stunning response rates and disease control rates seen with the triplet combination. So we saw disease control rate at 24 weeks in 77% of the study population and median progression free survival, 14.7 months, and response rate to this triplet combination of 87%, which is obviously very high. And these responses were durable with median duration of response 11 months in the whole study population. And in terms of the safety of this triplet regimen, the safety was acceptable. We didn't learn anything new about the safety that we didn't know about the single agent. So it had an acceptable safety profile.
I think the second key message from the study was what we learned from the doublet cohort. So this is the same patient population. It was a sequentially recruited cohort, but giving them olaparib and durvalumab. So without the bevacizumab. And response rates here were disappointingly low, response rates 34%, disease control rate 28%. And so it's clear that the triplet combination in this population is the active regimen. So we're seeing some additional synergy and benefit with the bevacizumab.
And this is something that we haven't seen before in other studies. The triplet combination was active regardless of something known as genomic instability status. So that was assessed in all tumors of the patients in this cohort based on foundation medicine profiling, using LOH score and somatic mutation testing of common DDR gene. So we saw responses regardless of the genomic instability status of the patients. So the triplet combination is exciting. It's already being investigated in the frontline setting in the DUO-O study, but I think it also warrants further investigation in this patient population as a treatment in itself, which is what we've shown in the trial.