GYNECOLOGIC CANCERS
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The phase III JAVELIN Ovarian PARP 100 study has been discontinued, according to Merck KGaA and Pfizer, the companies that collaborated on the trial.<sup> </sup>The ongoing trial was investigating the efficacy and safety of avelumab in combination with chemotherapy followed by maintenance avelumab in combination with talazoparib in patients with locally advanced or metastatic ovarian cancer.
Olaparib combined with neratinib may be a novel treatment option for patients with HER2-positive, homologous recombination–proficient ovarian cancer tumors that are resistant to chemotherapy, preclinical findings presented during the 2019 SGO Annual Meeting showed.<br />
Neratinib demonstrated durable responses and disease control and a manageable safety profile in patients with metastatic <em>HER2</em>-mutant cervical cancer, according to results from the ongoing phase II SUMMIT basket trial.
Women with recurrent ovarian cancer treated with the combination of pembrolizumab, bevacizumab, and metronomic cyclophosphamide had a 95% disease control rate and a 40% overall response rate, according to findings from an open-label phase II study presented during the 2019 SGO Annual Meeting.
Activity was seen with lenvatinib plus a weekly dose of paclitaxel in patients with recurrent endometrial and platinum-resistant epitherlial ovarian cancer, according to a presentation at the 50th SGO Annual Meeting. The combination resulted in a 65% overall response rate in a phase I trial.
Patients with high-risk ovarian cancer being treated with niraparib experienced a decrease in adverse events when treated with a 200- or 300-mg individualized starting dose based on bodyweight and platelet count compared with patients who received a fixed starting dose of 300 mg, according to data from a recent analysis of the ongoing ENGOT-OV26/PRIMA study.
Repeated use of PARP inhibitors may be a beneficial treatment strategy in the future for women with recurrent epithelial ovarian cancer, according to the results of a retrospective, multi-institutional study presented at the 2019 SGO Annual Meeting. The findings suggested that prior exposure to PARP inhibition may not lead to resistance, which could lead to increased use of repeat PARP treatment going forward.
Treatment with maintenance niraparib led to extended progression-free survival time in patients with recurrent ovarian cancer without the patients experiencing symptoms or toxicity compared with placebo, according to results of an analysis from the phase III ENGOT-OV16/NOVA trial. In patients with germline <em>BRCA</em>-mutated disease, the benefit was increased 4-fold and in patients non–germline <em>BRCA</em>-mutated ovarian cancer the benefit was increased 2-fold.
Ahead of the 50th Annual SGO Meeting, Shannon Westin, MD discussed the key takeaways from a case chat and highlighted some data she is looking forward to at the meeting for patients with recurrent ovarian cancer. She also highlighted other data that will play an important part in this treatment landscape and for patients with recurrent cervical cancer.
The healthcare community is still awaiting a response from the Centers for Medicare & Medicaid Services to the opposition of the agency’s proposal to substantially revise the Medicare Part D protected drug classes.
Platinum-Resistant Advanced Ovarian Cancer
Overtreating men 70 years or older with prostate cancer cost Medicare more than $1.2 billion from 2004 to 2007, according to the results of a retrospective study using the Surveillance, Epidemiology, and End Results–Medicare linked database.
Identifying the inflamed tumors that are most likely to respond favorably to immunotherapeutics and, conversely, finding ways to treat noninflamed tumors are essential for successful application of immunotherapy in endometrial cancer, according to a presentation at the 2019 Society of Gynecologic Oncology Annual Winter Meeting.
The phase III FORWARD I trial fell short of its primary endpoint, as findings showed the antibody-drug conjugate mirvetuximab soravtansine did not result in a progression-free survival improvement compared with chemotherapy in patients with folate receptor alpha–positive, platinum-resistant ovarian cancer and in an overall patient population.
According to Huma Q. Rana, MD, genetic testing provides valuable benefit in the treatment landscape of gynecologic cancers. It can inform physicians of the individual and familial risk for developing a malignancy, alert patients of potential screening and preventative measures, and guide selection of potential targeted therapies.
Advances in checkpoint inhibitor therapy have gained speed in cancer care; however, ovarian cancer has yet to see any approved indications for immunotherapy agents, said Lana E. Kandalaft, PharmD, PhD, to an audience at the European Society for Medical Oncology 2018 Immuno-Oncology Congress.
Data from a retrospective study suggests an adjuvant gastrointestinal-based chemotherapy regimen is more beneficial than one that is gynecologic-based in patients with mucinous ovarian cancer, said Katherine C. Kurnit, MD.
In an interview with <em>Targeted Oncology</em> during the 2019 SGO Annual Winter Meeting, Shannon Westin, MD, discussed the advances seen with PARP inhibitors in ovarian cancer, novel investigational agents, and the importance of molecular testing.
A look back at all the FDA news in oncology from the month of January 2019, including several new approvals, breakthrough therapy designations, and a partial clinical hold.
Targeted therapy has effectively been established as an option for patients with ovarian cancers. However, beyond PARP inhibition in the <em>BRCA</em>-mutated or homologous recombination deficient population, questions remain about how to best treat these patients, Ramez N. Eskander, MD, said at the 2019 SGO Annual Winter Meeting.