Dr Thaker on the Design of the MAESTRA 1 Trial in Platinum-Resistant Ovarian Cancer

“The nice thing about the MAESTRA 1 trial is it really makes sure that patients get the [standard] prior platinum-resistant ovarian cancer treatments.”

Premal H. Thaker, MD, MS, the David G. and Lynn Mutch Distinguished Professor of Obstetrics and Gynecology, chief of the Division of Gynecologic Oncology, and director of Gynecological Oncology Clinical Research at Siteman Cancer Center of Washington University in St. Louis, discussed the phase 2 MAESTRA 1 trial (NCT07023627), which is evaluating INCB123667 in patients with platinum-resistant ovarian cancer (PROC) and cyclin E1 overexpression.

MAESTRA 1 is helping redefine how oncologists evaluate treatment strategies in platinum-resistant ovarian cancer by reflecting a more realistic patient population and addressing a critical unmet need for additional therapeutic options, Thaker explained. Platinum resistance remains poorly understood, making trial design especially important when interpreting efficacy outcomes, she added. A key strength of MAESTRA 1 is its inclusion of patients who have already received standard prior therapies for platinum-resistant disease, ensuring the study population closely mirrors real-world clinical practice rather than a highly selected subgroup.

This approach provides greater confidence that any observed efficacy is meaningful and applicable to everyday oncology care, Thaker noted. Too often, retrospective questions arise about whether patients had previously received certain therapies that may have influenced outcomes. MAESTRA 1 attempts to eliminate that uncertainty by ensuring patients enter the study with treatment histories that align with what clinicians commonly encounter in practice.

Another notable aspect of the trial is its inclusion of patients who have undergone as many as 4 prior lines of therapy. Patients with PROC urgently need additional options, even after only 2 or 3 prior regimens. Expanding eligibility offers more patients the opportunity to participate in clinical research while also generating valuable insights into treatment sequencing.

Thaker noted that researchers are particularly interested in understanding whether there may be an optimal time to introduce therapy during the disease course. By analyzing outcomes across lines of treatment, investigators hope to develop hypotheses that can guide future sequencing strategies. Although the field has historically assumed that earlier intervention is preferable, MAESTRA 1 may help provide data-driven clarity on where these therapies are best suited.

This video was supported in part by Incyte. Content independently developed and published by OncLive.