Tesaro Highlights Benefits of Maintenance Therapy Zejula During Ovarian Cancer Awareness Month
Published: Sep 25, 2018 By Alex Keown
In 2015 Anne was diagnosed with stage III ovarian cancer. The diagnosis was made after she wound up in the emergency room complaining of severe back pain.
The diagnosis came as a complete shock and Anne immediately began a treatment regimen that included surgery. Months later she relapsed and was forced to continue treatment. Typically, when a woman has a recurrence of ovarian cancer, it is considered incurable. But, last year, Anne was told she was a good candidate for a newly-approved maintenance therapy that could halt or delay progression of the disease – Tesaro’s Zejula.
Formerly known as Niraparib, Zejula is an oral, once-daily PARP inhibitor used as maintenance treatment for ovarian cancer. It was the first PARP inhibitor to be approved by the U.S. Food and Drug Administration (FDA) that does not require BRCA mutation or other biomarker testing.
Since being placed on Zejula, Anne said she has something of a new lease on life. Her illness is under control and she’s been able to return to work – something she did not think was going to be possible.
Anne, along with Dr. Robert Holloway, the medical director of the Gynecologic Oncology Program at Florida Hospital, was part of an ovarian cancer awareness media blitz Tesaro conducted to highlight National Ovarian Cancer Awareness month.
Speaking to BioSpace, Holloway said there are a number of new treatment options for women with advanced ovarian cancer who have had a recurrence and responded to therapy to help them maintain remission. Holloway specifically pointed to Tesaro’s Zejula and said the once-per-day therapy is helping women maintain remission and and improve longevity and outcomes. Until Zejula, Holloway said, many patients had to go through a “wait and see” approach to their treatment. About 85 percent of patients went through a recurrence or relapse of disease, which required more chemotherapy or other treatments, Holloway said. When Zejula was approved last year though, ovarian cancer patients were able to benefit from the maintenance therapy and keep their cancers at bay.
“This is something that really benefits patients in the long run,” Holloway said.
Ovarian cancer is the fifth leading cause of cancer-related deaths in the United States. It is estimated that this year there will be more than 22,000 women in the U.S. diagnosed with the disease and about 14,000 disease-related deaths. The vast majority of diagnoses, about 80 percent, are found at an advanced stage.
Since the approval of Zejula last year, there has been significant movement in the treatment of ovarian cancer. The following are a few highlights from select company pipelines.
In June, Genentech received the green light from the U.S. Food and Drug Administration for Avastin (bevacizumab) as a treatment for stage III or stage IV ovarian cancer. The FDA approved Avastin in combination with chemotherapy followed by Avastin alone for the treatment of those cancer patients who have undergone initial surgical resection. According to the trial data that led to the regulatory approval, women who received Avastin in combination with chemotherapy, and continued use of Avastin alone, had a median progression-free survival of 18.2 months compared to 12 months in women who received chemotherapy alone.
Also in June, AstraZeneca and Merck revealed positive Phase III results from a trial testing Lynparza (olaparib) in BRCA-mutated (BRCAm) advanced ovarian cancer. Lynparza, also a PARP inhibitor, is being studied as a first-line maintenance therapy. The data showed patients treated with Lynparza demonstrated statistically significant and clinically meaningful improvement in progression-free survival compared to those receiving placebo. Lynparza is also being tested in another Phase III trial in combination with bevacizumab as first-line maintenance therapy for women with newly diagnosed advanced ovarian cancer, regardless of BRCA status. Data from that trial is expected in 2019.
In April West Lafayette, Indiana-based On Target Laboratories dosed the first patient in the Phase III trial of OTL38 in detecting ovarian cancer. As BioSpace previously reported, OTL38 is a ligand that targets folate receptors that appear in various types of cancers. OTL38 is injected into patients and includes an infrared dye that allows surgeons to visually identify cancer cells that can guide them in removing the cancer tissue.
Massachusetts-based ImmunoGen in March announced positive results from its FORWARD II trial that showed the combination of mirvetuximab soravtansine and Merck’s Keytruda yielded positive results in platinum-resistant epithelial ovarian cancer. Then in June, the FDA granted Fast Track designation to Immunogen’s mirvetuximab soravtansine for patients with medium to high folate receptor alpha (FRα)-positive platinum-resistant ovarian cancer who received at least one, but no more than three prior systemic treatment regimens. On its own, mirvetuximab soravtansine is being evaluated in a Phase III trial as a stand-alone treatment.
While Holloway noted there has been a significant improvement in treatment options for ovarian cancer patients, he said little headway has been made in the diagnosis of the disease. There has been some new understanding that there is a genetic component to ovarian cancer, which means women who have a family member diagnosed with the disease should proactively work with their doctors to watch for signs and symptoms of the disease.
“We’re hopeful for a blood test or other kind of test, but that’s not been brought forth yet,” Holloway said.