GYNECOLOGIC CANCERS

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.

The FDA has approved Zirabev, a biosimilar to bevacizumab for 5 indications.&nbsp;Zirabev has been approved for the treatment of patients with metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic non-squamous non&ndash;small cell lung cancer; recurrent glioblastoma; metastatic renal cell carcinoma; and persistent, recurrent or metastatic cervical cancer.

A prefilled syringe of&nbsp;lanreotide has been approved by the FDA to&nbsp;enable healthcare providers to administer the injection easier to adults with unresectable, well or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors.

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.

ABP 980, a trastuzumab biosimilar, has been approved by the FDA&nbsp; for the treatment of patients with HER2-overexpressing breast cancer as well as HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, marking the fifth approval by the agency for a trastuzumab biosimilar.

During a recent&nbsp;<em>Targeted Oncology&nbsp;</em>live case-based peer perspectives presentation, Tanios Bekaii-Saab, MD, discussed with a group of physicians the treatment options for patients with gastrointestinal cancers and the characteristics that influence his decision making. Bekaii-Saab explained his clinical decisions based on the case scenario of one patient with colorectal cancer and one with hepatocellular carcinoma.

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.

In an interview with&nbsp;<em>Targeted Oncology,&nbsp;</em>Emese Zsiros, MD, PhD, discussed the findings from this phase II trial investigating the triplet regimen in patients with recurrent disease. In addition, she shared details for the next steps planned for this regimen.

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;

Announced at the 2019 ASCO Annual Meeting, the FDA is rolling out a pilot program that will provide more information and assistance for acquiring expanded access (EA) to investigational therapies for both oncologists and patients. The program is being called Project Facilitate.

Results from a survey conducted by the Society of Gynecologic Oncology found that&nbsp;70% of female and more than half of male&nbsp;gynecologic oncologists in the United States were victims of sexual harassment in either training or practice; and of those, only 10% said they reported their experiences.

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.

In an interview with&nbsp;<em>Targeted Oncology</em>, experts in gynecology, gastrointestinal, genitourinary, lung, and breast cancers spoke to the significance of the abstracts they are most looking forward to at the 2019 ASCO Annual Meeting.

Dostarlimab (TSR-042), an&nbsp;investigational anti&ndash;PD-1 therapy, demonstrated durable responses across subgroups of patients with&nbsp;microsatellite instability&ndash;high and microsatellite stable advanced or recurrent endometrial cancer, according to results&nbsp;from the phase I/II GARNET study.

The FDA has granted a breakthrough therapy designation to novel tumor-infiltrating lymphocyte therapy LN-145 for the treatment of patients with recurrent, metastatic, or persistent cervical cancer who have progressed on or after chemotherapy.