GYNECOLOGIC CANCERS

Jaron Mark, MD, gynecologic oncology fellow at Roswell Park Comprehensive Cancer Center, discusses findings from a restrictive protocol that limited the number of opioids prescribed after gynecologic surgeries. Patients looked at in this trial had undergone ambulatory or minimally invasive procedures. 

Several new indications were approved by the FDA in March, including blinatumomab (Blincyto) for MRD+ ALL, brentuximab vedotin (Adcetris) for Hodgkin lymphoma, and a 4-week nivolumab (Opdivo) dosing schedule across several indications. Here’s a look back on the FDA happenings for the month of March 2018.

Ira Winer, MD, PhD, assistant professor in the the Division of Gynecologic Oncology at Wayne State University, discusses the outlook on immunotherapy in the treatment landscape of gynecologic cancers. 

Ursula A. Matulonis, MD, director, Gynecologic Oncology, Dana-Farber Cancer Institute, professor of medicine, Harvard Medical School, discusses initial safety and activity findings from a phase IB escalation study of mirvetuximab soravtansine, a folate receptor alpha-targeting antibody-drug conjugate, with pembrolizumab (Keytruda) in patients with platinum-resistant epithelial ovarian cancer.

Blinatumomab (Blincyto) has been granted an accelerated approval by the FDA for the treatment of patients with B-cell precursor acute lymphoblastic leukemia who are in remission but still have minimal residual disease.

The combination of first-line platinum-containing chemotherapy plus the anti-PD-1 agent pembrolizumab (Keytruda), followed by pembrolizumab maintenance therapy, was safe and tolerable in patients with advanced ovarian cancer, according to preliminary data from a small clinical trial presented at the 2018 Society of Gynecologic Oncology Annual Meeting.

The results of a network meta-analysis, which compared efficacy and safety findings from studies of 3 FDA-approved PARP inhibitors as maintenance therapy for patients with relapsed platinum-sensitive ovarian cancer, demonstrated that similar efficacy results were seen across the 3 PARP inhibitors, but safety results differed. 

According to results from the phase II MEDIOLA trial, the combination of olaparib (Lynparza), a PARP inhibitor, and durvalumab (Imfinzi), a PD-L1 inhibitor, was found to induce objective responses in over 70% of patients with relapsed, platinum-sensitive, BRCA-mutated ovarian cancer.

Results from a phase I/II trial indicated that durable responses could be achieved with the combination of niraparib (Zejula), a PARP inhibitor, and pembrolizumab (Keytruda), a PD-1 inhibitor, in patients with platinum-resistant/refractory ovarian cancer.

Rodney P. Rocconi, MD, chief of Gynecologic Oncology Service, associate director for Clinical Research, professor of Interdisciplinary Clinical Oncology, discusses a phase I trial of Vigil personalized engineered autologous tumor cells in ovarian cancer during the 2018 Society of Gynecologic Oncology Annual Meeting.

A combination regimen of pembrolizumab (Keytruda) and mirvetuximab soravtansine (IMGN853) induced responses in close to half of the patients in a small study of platinum-resistant ovarian cancer .

When trastuzumab (Herceptin) was added to chemotherapy, a more than 50% improvement in progression-free survival (PFS) was observed compared with chemotherapy alone in patients with HER2-positive uterine serous carcinoma (USC), according to findings from a small randomized trial.

Alessandro D. Santin, MD, a professor of obstetrics, gynecology, and reproductive sciences at Yale School of Medicine, discusses results of a randomized phase II trial of trial of carboplatin-paclitaxel compared to carboplatin-paclitaxel-trastuzumab (Herceptin) in advanced or recurrent uterine serous carcinomas that overexpress HER2/neu during the 2018 Society of Gynecologic Oncology Annual Meeting.

The United States Food and Drug Administration approved several maintenance therapies over the last few years for the management of platinum-sensitive recurrent ovarian cancer. Bevacizumab (Avastin), TKIs, or PARP inhibitors were among the treatments used in the clinical trials leading to these approvals.

A prospective study found that implementing an “ultra-restrictive” opioid prescription protocol for gynecologic surgery had led to an 89% reduction in opioid tablets dispensed at discharge and a high rate of patient satisfaction.

In an analysis of the phase III ENGOT-OV16/NOVA study, baseline body weight and platelet counts served as early biomarkers for patients with platinum-sensitive, relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who would require dose modifications to their treatment with niraparib (Zejula).

According to study findings presented during the 49th Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancers held in New Orleans March 24-27, clinical benefit has been found for women with recurrent ovarian cancer when using immune checkpoint inhibitors, but there was a higher rate of adverse events (AEs) than previously reported in other tumor types.

Michael Birrer, MD, PhD, professor of medicine in the Division of Hematology-Oncology, and Director of the Comprehensive Cancer Center at the University of Alabama at Birmingham, discusses current data on predicting response to PARP inhibitor therapy in ovarian cancer.