Ovarian Cancer

In June 2019, the FDA approved a number of agents many fields, including diffuse large B-cell lymphoma, head and neck squamous cell carcinoma, small cell lung cancer, gastroenteropancreatic neuroendocrine tumors, and multiple myeloma. The FDA also approved the fifth biosimilar for trastuzumab and another biosimilar for bevacizumab across several indications.

In an interview with <em>Targeted Oncology, </em>Richard T. Penson, MD,&nbsp;discussed the significance of the findings recently presented for the SOLO3 trial in patients with platinum-sensitive, relapsed <em>BRCA-</em>positive ovarian cancer.

Susan Friedman, executive director and founder, FORCE, a non-profit organization supporting education, advocacy, and research around breast and ovarian cancer, explains the relevance of PARP inhibitors and the recent developments in oncology research that may improve cancer treatment for patients with genetic mutations.

A priority review designation has been granted by the FDA to a supplemental&nbsp;biologics license application for niraparib as a treatment for patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with &ge;3 prior chemotherapy regimens, and who have either a&nbsp;<em>BRCA&nbsp;</em>mutation or have homologous recombination deficiency and progressed &gt;6 months after their last platinum-based regimen.

The American Cancer Society, Dana-Farber Cancer Institute, Baptist Cancer Center, and the Mayo Clinic report&nbsp;that treatment patterns varied markedly by cancer type and care facility setting for patients with de novo metastatic disease who died within 1 month after diagnosis, based on an analysis of data from 100,848 patients collected from the National Cancer Database, a hospital-based cancer registry that captures 70% of patients in the United States with a new diagnosis.

Olaparib has been approved by the European Commission as a treatment in the maintenance setting for adult patients&nbsp;with advanced <em>BRCA1/2</em>-mutated germline and/or somatic high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response following frontline treatment with a platinum-based chemotherapy.

The FDA recently released 5 new draft guidance documents that promote broader patient eligibility for cancer clinical trials. The policies encourage inclusion of certain individuals who were previously disqualified due to medical conditions or biological factors, including brain metastases, organ dysfunction, prior or concurrent malignancies, chronic infections, and age.

A cohort of cancer centers was selected to serve as models for identifying key strategies for racial and ethnic minority group engagement in clinical trials. On the basis of several qualifying criteria, such as sustained accrual of minorities into clinical cancer research, an established minority population &ge;10% in the overall catchment, an established clinical trial infrastructure, and a formal community outreach program, the investigators identified 8 cancer centers for participation.

In a case-based-style discussion, Tanios S. Bekaii-Saab, MD, and Wells Messersmith, MD, reviewed the treatment of patients with colorectal cancer whose tumors express rare gene mutations or molecular signatures, such as <em>NTRK</em> fusions.

One set of researchers are exploring the possibility of re-challenging patients with ovarian cancer with PARP inhibitors later in the course of treatment when their disease became recurrent. As the first to examine re-challenging patients with PARP inhibitors, researchers found that patients who had prior exposure to PARP inhibitors did not develop resistance and could, therefore, receive repeat treatment with PARP inhibitors.

Compared to chemotherapy, treatment with the PARP inhibitor olaparib reduced the risk of disease progression or death by 38% in patients with platinum-sensitive, relapsed, germline&nbsp;<em>BRCA1/2</em>-mutated ovarian cancer who had received at least 2 prior chemotherapy regimens, based on topline findings from the confirmatory phase III SOLO3 trial.

The combination of niraparib and bevacizumab demonstrated a significant increase in progression-free survival compared with niraparib alone in patients with platinum-sensitive recurrent ovarian cancer, according to the results of the randomized ENGOT-OV24 trial.<br /> &nbsp;

Mansoor Mirza, MD, chief oncologist, Department of Oncology, Copenhagen University Hospital, discusses the findings from NSGO-AVANOVA2/ENGOT-OV24, the randomized controlled chemotherapy-free study of niraparib (Zejula) and bevacizumab (Avastin) versus niraparib alone in recurrent platinum-sensitive ovarian cancer.

After passage of the Affordable Care Act, women with ovarian cancer who were pre-medicare-aged were more likely to be diagnosed at an early stage and receive treatment within 30 days of diagnosis compared to prior to the ACA, according to findings presented at the 2019 ASCO Annual Meeting.

Advanced Ovarian Cancer