Dr Mujumdar on Key Trials Evaluating Treatments for Ovarian Cancer

Vaidehi Mujumdar, MD, first-year gynecology oncology fellow, Atrium Health Levine Cancer Institute, discusses several key trials that have helped shift the ovarian cancer treatment paradigm.

In 2018, data from the phase 3 SOLO-1 trial (NCT01844986) led to the FDA approval of olaparib (Lynparza) for the frontline maintenance treatment of patients with treatment-naive, advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer harboring germline and somatic BRCA mutations, marking it as the first PARP inhibitor indicated for first-line maintenance therapy in this patient population, Mujumdar begins. Following this, several phase 3 trials, including PRIMA (NCT02655016), PAOLA-1 (NCT02477644), ARIEL3 (NCT01968213), and ATHENA-MONO (NCT03522246), evaluated the use of first-line PARP inhibitors in patients beyond the BRCA-mutated population and explored combination treatments with bevacizumab (Avastin), she explains.

The PRIMA trial led to the 2020 FDA approval of niraparib (Zejula) for patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy, regardless of biomarker status, Mujumdar says. The PAOLA-1 trial resulted in the FDA approval of the combination of olaparib and bevacizumab for patients with HRD-positive advanced ovarian cancer, including those who may also present with a BRCA mutation, Mujumdar notes. Additionally, in December 2022, the FDA restricted the use of rucaparib (Rubraca) to the second-line maintenance setting and beyond, specifically for patients with recurrent ovarian cancer harboring BRCA mutations, she continues.

Furthermore, at the 2023 ESMO Congress, investigators presented data with senaparib (IMP4297) maintenance therapy in patients with advanced ovarian cancer from the phase 3 FLAMES trial (NCT04169997), Mujumdar expands. This PARP inhibitor generated an improvement in progression-free survival compared with placebo in all patients with advanced ovarian cancer who responded to frontline platinum-based chemotherapy (HR, 0.43; 95% CI, 0.32-0.58; P < .0001), she elucidates. Although it remains uncertain whether the oncology community will adopt yet another PARP inhibitor, senaparib appears to be a promising agent with activity in the maintenance setting across all patients with ovarian cancer, Mujumdar concludes.