Stenoparib wins FDA fast track status for advanced ovarian cancer
Drug is alternative to platinum-based medications that some may not tolerate
The U.S. Food and Drug Administration (FDA) has given fast track status to stenoparib, an experimental treatment Allarity Therapeutics has been testing for advanced ovarian cancer.
The designation, granted to drugs that may meet a serious medical need, allows closer and more frequent communication with the FDA and may give access to faster pathways toward its approval, such as accelerated, priority or rolling review, if the treatment meets certain criteria.
“We are very pleased that the FDA has granted fast track designation to stenoparib,” Thomas Jensen, CEO of Allarity, said in a company press release. “We look forward to engaging closely with the FDA as we advance this program.”
A type of gynecological cancer, ovarian cancer develops in the reproductive organs that produce eggs in women. It’s often treated with medications that contain platinum, such as cisplatin and carboplatin, which can make tumors smaller and slow their growth. Some women can’t be treated with platinum-based medications due to other health problems or hypersensitivity to the metal, however. Others become resistant, meaning their cancer stops responding to treatment.
What is stenoparib?
Stenoparib may offer an alternative, and receiving fast track designation “underscores the significant unmet need facing women with advanced ovarian cancer and reflects the potential of stenoparib to meaningfully improve treatment outcomes,” Jensen said.
First developed by Eisai as E7449 and later known as 2X-121, stenoparib is an oral small molecule that blocks both the PARP1/2 and tankyrase 1/2 enzymes, which are involved in the growth of a number of cancers. Blocking the enzymes is expected to stop tumors from growing.
A Phase 1 clinical trial (NCT01618136) showed stenoparib as an add-on treatment was well tolerated and prolonged survival in patients with solid cancers, including five with ovarian cancer, and Allarity is now enrolling patients in a Phase 2 clinical study (NCT03878849).
The trial’s main goal is to identify the optimal dose of stenoparib, given on its own at 600 or 800 mg daily as hard gelatin capsules, for women with advanced, recurrent ovarian cancer who can’t be treated with platinum-based medications or have become resistant to them. Several patients have been receiving treatment since June.
The researchers will also evaluate the clinical benefit of stenoparib, along with changes in progression-free and overall survival, disease control, and objective response rates from the start of the study up to about two years of treatment.
For the study, Allarity has used its Drug Response Predictor (DRP) platform to select patients who, based on their cancer’s genetic profile, would be more likely to benefit from stenoparib. DRP also lets researchers identify biomarkers of response or resistance to treatment.
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