GYNECOLOGIC CANCERS

The FDA pushed back its the Biologic License Application filing for the potential approval of balstilimab as treatment of recurrent/metastatic cervical cancer.

In an interview with Targeted Oncology during the 2020 Association for Molecular Pathology Annual Meeting, Ozge Ceyhan-Birsoy, PhD, discussed genetic testing methods for patients with hereditary predisposition and the molecular research underway at MSKCC to improve testing in this patient population.

Ursula Matulonis, MD, took stock of the role for immunotherapy agents in the treatment landscape for ovarian, recurrent/advanced endometrial, and recurrent/advanced cervical cancers.

Several late-phase results were shared during the European Society of Medical Oncology Virtual Congress in gynecologic malignancies, but the data presented generated excitement about the number of novel options for patients after initial treatment.

Robert L. Coleman, MD, discusses the next steps for tisotumab vedotin following the presentation of findings from the phase 2 innovaTV 204/GOG-3023/ENGOT-cx6 study in patients with previously treated recurrent or metastatic cervical cancer.

In patients with newly diagnosed stage III/IV ovarian cancer, adding atezolizumab to a backbone combination of bevacizumab and chemotherapy did not improve progression-free survival, missing the primary end point of the phase 3 IMagyn050/GOG 3015/ENGOT-OV39 trial presented during the virtual 2020 European Society of Medical Oncology Congress.

Patients with epithelial ovarian cancer treated with weekly dose-dense chemotherapy in the ICON8 clinical trial experienced similar progression-free survival and overall survival as patients treated with the standard-of-care.

In the phase 2 single-arm innovaTV 204 trial, treatment with tisotumab vedotin led to an objective response rate (ORR) of 24% (95% CI, 15.9%-33.3%) in patients with recurrent and/or metastatic cervical cancer who were previously treated with doublet chemotherapy and bevacizumab (Avastin). The encouraging result was announced during a presentation at the 2020 European Society of Medical Oncology (ESMO) Virtual Congress.

Patient-reported outcomes data showed the quality of life was not reduced with niraparib in patients with ovarian, primary peritoneal, or fallopian tube cancer compared with placebo.

In the phase 1 GARNET trial, durable antitumor activity was observed with dostarlimab in patients with advanced or recurrent DNA mismatch repair deficient and proficient endometrial cancer. The disease control rate was promising and the safety profile of the agent was tolerable, according to results presented during the 2020 European Society of Medical Oncology Virtual Congress.

In patients with recurrent/metastatic cervical cancer, the PD-1 inhibitor balstilimab monotherapy or combined with the CTLA-4 inhibitor zalifrelimab demonstrated promising objective response rates no matter the patients PD-L1 status, plus a tolerable safety profile, according to data from 2 independent phase 2 trials presented during the 2020 ESMO Virtual Congress.

Leslie M. Randall, MD, discussed the case of a 49-year-old African American patients with BRCA-mutated ovarian cancer.

Ronald D. Alvarez, MD, MBA, weighs the pros and cons of adding bevacizumab to olaparib as treatment of a 69-year-old male patients with BRCA-mutant ovarian cancer.

The case of a 49-year-old African American woman with ovarian cancer was discussed during a virtual Case Based Peer Perspective event led by Matthew L. Anderson, MD, PhD.

“What we’re trying to do is move toward more personalized precision medicine based on what actually happens inside the tumor."

The FDA has granted a fast track designation to a novel antibody-drug conjugate for the treatment of patients with platinum-resistant high-grade serous ovarian cancer who have received up to 3 prior lines of systemic therapy, or for patients who previously received 4 lines of systemic therapy regardless of their platinum status.

The expanded version of the BD Onclarity HPV Assay received approval for a pre-market approval supplement from the FDA, making it the only assay approved right now that individually identifies and reports human papillomavirus genotypes 31, 51, 52, 33/58, 35/39/68, and 56/59/66, as well as the standard 16,18, and 45.

A pathogenic germline mutation rate of about 5% has been identified in women who had a family history of breast or ovarian cancer but no personal history of either disease.

The first randomized study of an ATR inhibitor in any malignancy demonstrated the benefit of berzosertib added to gemcitabine as treatment of patients with platinum-resistant high-grade serous ovarian cancer, according to a recently published study.

In an interview with Targeted Oncology, Joyce F. Liu, MD, MPH, discussed the details of the phase 2 study of adavosertib in recurrent uterine serous carcinoma and the implications of this research for clinical practices.

According to investigators on the phase 2 I-SPY 2 study, the addition durvalumab plus olaparib to treatment with neoadjuvant paclitaxel led to better pathologic complete response rates in patients with high-risk, HER2-negative stage II/III breast cancer compared with paclitaxel alone.

Leslie M. Randall, MD, MAS, discussed the treatment regimens available for an African American patient with ovarian cancer.

Bradley Monk, MD, discusses the phase 1b/2 innovaTV 205 trial in patients with recurrent or metastatic cervical cancer.

The addition of trastuzumab to chemotherapy in patients with uterine serous carcinoma had superior outcome compared with chemotherapy alone.

"Available therapies upon progression after first-line chemotherapy in recurrent or metastatic cervical cancer are limited, and there is a significant unmet need for new treatment options."

With multiple treatment options available in the ovarian cancer landscape, experts are now looking for an answer to the challenging question of optimal sequencing.

“Cervical cancer screening rates are suboptimal among Asian American women, despite considerable efforts to improve Pap test screening."

“We are starting to see more and more patients with recurrent ovarian cancer, we’re treating them much more aggressively in the up-front setting, and we have to face PARP inhibitor resistance in the future.”

Mansoor R. Mirza, MD, discusses the results of the PRIMA study of niraparib in patients with advanced ovarian cancer and the evaluation of the starting dose in these patients.

In the treatment landscape for advanced cervical cancer, no approved options exist for patients after first-line treatment. Based on phase 2 data, camrelizumab plus apatinib is showing promise.