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EMA Accepts Marketing Authorization Application for Mirvetuximab Soravtansine in FRα+, Platinum-Resistant Ovarian Cancer
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The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion regarding the approval of a Type II variation application for rucaparib as a frontline maintenance in patients with advanced ovarian cancer who have responded to first-line, platinum-based chemotherapy, irrespective of BRCA mutational status.

The combination of the novel MCT inhibitor CYT-0851 and capecitabine displayed clinical activity and a tolerable safety profile in patients with advanced platinum-resistant ovarian cancer.

The FDA has granted fast track designation to AVB-001 for the treatment of adult patients with relapsed/refractory, platinum-resistant, high-grade serous adenocarcinoma of the ovary, primary peritoneum, or fallopian tube.

Treatment with the interleukin-12 gene-mediated immunotherapy IMNN-001 in combination with neoadjuvant platinum chemotherapy led to an improvement in progression-free survival compared with neoadjuvant chemotherapy alone in newly diagnosed patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer.

The FDA has granted fast track designation to IDE161 for the treatment of adult patients with advanced or metastatic ovarian cancer harboring germline or somatic BRCA1/2 mutations who are platinum resistant and have received prior treatment with antiangiogenic and PARP inhibitor therapies.

Bhavana Pothuri, MD, discusses treatment considerations for patients in tough-to-treat subgroups of ovarian cancer based on currently available data.

The addition of the PD-L1 inhibitor atezolizumab to bevacizumab and platinum-based chemotherapy did not result in a statistically significant progression-free survival benefit among patients with recurrent epithelial ovarian cancer.

Martin Cannon, PhD, discusses data seen with immune checkpoint inhibitors in patients with ovarian cancer and why these agents are not as effective in this population as they are in other cancer types.

Kathleen N. Moore, MD, MS, discusses the design of the ongoing, first-in-human, phase 1/2 study of the MUC16- and CD3-targeted bispecific antibody ubamatamab alone or in combination with cemiplimab in patients with recurrent ovarian cancer.

Heather R. Williams, MD, expands on updated data from the the phase 3 PRIMA trial initially supporting the use of frontline PARP inhibitor maintenance in ovarian cancer, as well as changing indications for niraparib based on data from the NOVA trial.

The well-publicized severe shortage of vitally important generic antineoplastic agents has highlighted a serious misalignment in the existing market-based and regulatory environment that permitted such an extraordinary situation to develop without meaningful resolution.

The efficacy of maintenance mirvetuximab soravtansine plus bevacizumab is being compared with bevacizumab alone in patients with folate receptor alpha–positive recurrent platinum-sensitive epithelial ovarian, fallopian tube, or peritoneal cancers that did not progress on second-line triplet therapy in the phase 3 GLORIOSA study.

Martin Cannon, PhD, delves into ongoing research on the use of dendritic cell vaccines to generate Th17 responses in patients with ovarian cancer and details how this could address a need for select patients with ovarian cancer.

Martin Cannon, PhD, details the history of investigating immune checkpoint inhibitors in patients with ovarian cancer and expands on the questions that need to be answered to potentially improve the activity of these agents in this patient population.

Heather R. Williams, MD, discusses the evolution of the ovarian cancer treatment paradigm over the past several decades, as well as the importance of continuing to investigate individualized treatment approaches in this population to expand therapeutic options after disease recurrence.

Martin Cannon, PhD, discusses explanations for the lack of success with immune checkpoint inhibitors in ovarian cancer, and how to potentially improve responses to immunotherapy approaches in this tumor type.

The addition of tumor treating fields to paclitaxel did not result in a statistically significant improvement in overall survival vs paclitaxel alone in patients with platinum-resistant ovarian cancer, failing to meet the primary end point of the phase 3 ENGOT-ov50/GOG-3029/INNOVATE-3 trial.

Maintenance therapy with the PARP inhibitor niraparib prolonged progression-free survival vs placebo in patients with newly diagnosed advanced ovarian cancer.

Heather R. Williams, MD, discusses the mechanism of action of antibody-drug conjugates and ADC targets under investigation in patients with ovarian cancer.

Heather R. Williams, MD, discusses ocular toxicities associated with antibody-drug conjugates and strategies for managing these toxicities in patients with ovarian cancer.

Martin Cannon, PhD, discusses the phase 1 investigation of the Th17 dendritic cell vaccine in ovarian cancer, and how it could potentially improve suboptimal responses when treated with immunotherapy alone in this population.

Michael J. Birrer, MD, PhD, discusses how the expansion of antibody-drug conjugates can address the need for more effective regimens in platinum-resistant ovarian cancer.

Whitney S. Graybill, MD, MS, presents data from an analysis of the phase 3 PRIMA trial that looked to identify baseline characteristics associated with long-term progression-free survival with niraparib in patients with advanced ovarian cancer.

Kathleen N. Moore, MD, MS, discusses the eligibility criteria for the ongoing, first-in-human, phase 1/2 study of ubamatamab, a MUC16- and CD3-targeted bispecific antibody, alone or in combination with cemiplimab in patients with recurrent ovarian cancer.

Heather R. Williams, MD, discusses the importance of further exploring the use of antibody drug conjugates in ovarian cancer, specifically highlighting the investigation of mirvetuximab soravtansine in this population.
























































