Shannon N. Westin, MD, MPH, FACOG, discusses the DUO-E trial, which evaluated durvalumab, a PD-L1 inhibitor, with or without olaparib in patients with endometrial cancer, design, and end points.
Shannon N. Westin, MD, MPH, FACOG, a gynecologic oncologist at The University of Texas MD Anderson Cancer Center discusses the DUO-E trial, which evaluated durvalumab (Imfinzi), a PD-L1 inhibitor, with or without olaparib (Lynparza) in patients with endometrial cancer, design, and end points.
According to Westin, DUO-E trial (NCT04269200) is a randomized, placebo-controlled trial. It has 3 arms. In arm 1, patients receive chemotherapy alone followed by a placebo. In arm 2, patients received chemotherapy with durvalumab followed by durvalumab maintenance and a placebo. In arm 3, patients received chemotherapy, durvalumab, and olaparib maintenance. It has a target enrollment of 699 patients, with a primary end point of progression-free survival (PFS).
Several patients included in the study are of higher risk, according to Westin. The trial does not exclude patients with a history of carcinosarcoma. Patients who have received prior chemotherapy and those with recurrent endometrial cancer are also eligible to participate if it has been longer than year.
0:08 | It's got 3 arms and patients are randomized either to get chemotherapy alone, followed by placebo maintenance or the chemotherapy with durvalumab followed by durvalumab maintenance and a placebo. The third arm has all of the interventions, which is the chemotherapy, durvalumab, and olaparib maintenance. It'll be about 699 patients that are randomized, the primary end point is PFS. So, we're well on our way the enrollments going beautifully. Hopefully, we'll have some answers over the next few years.
0:53 | We include several patients that are even at a higher risk. Many of these types of trials will exclude patients who have the histology carcinosarcoma, which is one of the more aggressive subtypes. But we are including that in our trials. So, we're excited to see if we can get benefit for that patient population. In addition, we are allowing patients to have prior chemotherapy, so those patients that have a recurrent endometrial cancer, can have had prior chemotherapy if it's been more than a year. So that's a few of the unique pieces of this trial that will hopefully expand eligibility and also really give us an idea of activity in all these different populations.