GYNECOLOGIC CANCERS

The FDA has granted a Fast Track designation for the evaluation of balstilimab in combination with zalifrelimab for the treatment of patients with relapsed or refractory metastatic cervical cancer, according to a press release from Agenus, Inc., the developer of balstilimab. Comprehensive data supporting the potential of the combination served as the basis for the designation.

The addition of cediranib to olaparib did not result in improved progression-free survival in comparison with platinum-based chemotherapy in patients with platinum-sensitive relapsed ovarian cancer, which was the primary end point of the phase III NRG-GY004 trial, according to a press release from AstraZeneca and Merck.

Acelarin demonstrated clinical activity in patients with platinum-resistant ovarian cancer who were heavily pretreated with at least 3 lines of chemotherapy, according to preliminary results from part 1 of phase II PRO-105 study, announced in a press release from the drug developer, NuCana plc.

The FDA has accepted a Biologics License Application for MYL-1402O, a proposed biosimilar to bevacizumab, according to a press release from co-developers Biocon and Mylan. The BLA is seeking approval for the biosimilar as a treatment for multiple types of cancer and the FDA has set an action date goal of December 27, 2020, for a decision on the BLA.

As the new coronavirus disease 2019 creates problems internationally, health-wise and economically, it is also becoming a cause for concern throughout the oncology community.

In an interview with Targeted Oncology, Alexandra S. Bercow, MD, discussed the results from a retrospective study, which evaluated the role of palliative care in women who died from cervical cancer between 2000 and 2017 at 2 institutions. She also highlighted the benefit of palliative care and why this patient population could benefit more than those with ovarian or endometrial cancers.

In February 2020, the FDA gave indications to multiple therapies meant for treatment of solid tumor and hematologic malignancies. FDA action included 10 Priority Reviews, 2 Breakthrough Therapy designations, and 2 Fast Track designations.

Floor J. Backes, MD, discusses the immunotherapeutic options available for treatment of patients with ovarian cancer.

Updated results from the phase II arm of the DeCidE1 trial of DPX-Survivac demonstrated promising activity and tolerability in patients with heavily pretreated, advanced recurrent ovarian cancer, according to the developer of the agent IMV Inc.

Researchers at the Fox Chase Center have identified MRCKA, a serine/threonine-protein kinase, as a target for treating high-grade serous ovarian carcinoma, the most lethal of gynecologic malignancies, for which few targeted therapies exist. The research was recently published in Science Signaling, Fox Chase announced in a press release.

To help clinicians cope with an increasing number of geriatric patients with cancer, the Association of Community Cancer Centers is addressing this problem with a 2-pronged approach that focuses on the delivery of care and diagnostic assessment.

A 56-Year-Old Female With Recurrent Ovarian Cancer

An open, multicenter phase II trial of extend-release onapristone in patients with progesterone receptor–positive recurrent granulosa cell ovarian cancer, low-grade serous ovarian/primary peritoneal cancer, or endometroid endometrial cancer will demonstrate if the investigational drug will shrink or stop the cancer.

In January 2020, the FDA approved new treatment options in gastrointestinal stromal tumors, bladder cancer, and epithelioid sarcoma. The FDA also granted several Priority Review Designations, orphan drug designations, and a Fast Track designation, as well as a Breakthrough Therapy designation.

Continuous dosing of the MEK inhibitor binimetinib plus buparlisib, a PI3K inhibitor, demonstrated promising activity as treatment of patients with ovarian cancer harboring either a RAS or BRAF mutation, according to results from a phase Ib clinical trial.

Mira Hellmann, MD, discusses how the use of PARP inhibitors as treatment of patients with gynecologic cancers has evolved since they were first introduced into the treatment landscape up to studies evaluating these therapies today in a variety of patient populations, particularly in patients with ovarian cancer.

Research has shown that patients with para-aortic lymph node metastasis, human papillomavirus-18, and those with certain histocompatibility genes in their cervical tumors also have a poor prognosis. Preclinical research suggests, however, that immune checkpoint blockade with radiation can enhance immune-mediated activity in patients who have up to stage IV disease.

In an interview with Targeted Oncology, Vincent Chung, MD, discussed the findings from the pilot trial evaluating the addition of dietary supplements to combination chemotherapy in patients with unresectable pancreatic cancer. He also highlighted the importance of these findings and the next steps necessary to evaluate the role of supplements in pancreatic cancer further.

Promising antitumor activity with durable responses were demonstrated with the combination of nivolumab and ramucirumab plus paclitaxel in a phase II study of patients with advanced gastric cancer, which wsa presented at the 2020 Gastrointestinal Cancers Symposium. Among patients treated with the combination, the objective response rate was 37.2%, and all responders had a partial response.

Overall survival was meaningfully improved with treatment of pembrolizumab in first and later lines for patients with advanced gastric/gastroesophageal junction cancer with a high number of PD-L1–expressing cells in the tumor, lymphocytes, and macrophages compared with chemotherapy.