Stenoparib may improve survival in hard-to-treat ovarian cancer: Data
Median survival time in trial estimated to likely be longer than two years
The experimental therapy stenoparib (2X-121) may help extend survival in people with hard-to-treat ovarian cancer, according to new clinical trial data announced by the therapy’s developer, Allarity Therapeutics.
The company presented the findings earlier this month at the American Association for Cancer Research’s (AACR) 7th Biennial Special Conference on Ovarian Cancer in a poster titled “2X-121- a novel, dual inhibitor of PARP and tankyrase- shows promising clinical benefit in a phase 2 trial in advanced, recurrent ovarian cancer patients (NCT#03878849).”
“These emerging clinical results presented at the AACR Special Conference on Ovarian Cancer suggest that stenoparib may offer meaningful extended survival benefit for patients with advanced, platinum-resistant ovarian cancer (PROC) — a population with historically poor outcomes and limited treatment options,” Thomas Jensen, Allarity’s CEO, said in a company press release.
Stenoparib designed to block activity of 2 molecular pathways
Ovarian cancer is a form of gynecological cancer that begins in the ovaries, though in some cases, it can also originate in the fallopian tubes or peritoneum. Standard first-line treatment normally involves platinum-based chemotherapies, but patients whose cancers develop resistance to platinum agents have limited options.
Stenoparib is an oral therapy designed to block the activity of two molecular pathways: the PARP pathway, which is involved in DNA repair, and the WNT pathway, which drives cell growth and development. By simultaneously inhibiting both pathways, the therapy aims to prevent cancer cells from growing and promote the accumulation of DNA damage in those cells, ultimately leading to cancer cell death.
Allarity is sponsoring a Phase 2 clinical trial (NCT03878849) testing stenoparib in adults with advanced platinum-resistant ovarian cancer.
We are particularly excited that the median overall survival in this trial has not yet been reached and exceeds 25 months — that’s nearly 10 months longer than the [median overall survival] reported for the most recent FDA approvals and advances in therapy for PROC patients.
The presentation at the AACR conference included survival data from 15 patients given twice-daily stenoparib. With a median follow-up time of 22 months, results showed that the median overall survival time has not yet been reached — in other words, most of the patients are still alive. Statistical analyses estimate that the median survival time in the trial is likely to be longer than two years.
To put that in context, according to Allarity, median overall survival time with chemotherapy alone is usually about a year in this patient population. Recently approved therapies have reported slightly longer survival times, but median overall survival is usually less than 1.5 years, according to the company.
“We are particularly excited that the median overall survival in this trial has not yet been reached and exceeds 25 months — that’s nearly 10 months longer than the [median overall survival] reported for the most recent FDA approvals and advances in therapy for PROC patients,” Jensen said.
Phase 2 trial still recruiting participants
Allarity reports that stenoparib has shown benefits in patients who are heavily pretreated or who don’t carry a mutation in the BRCA gene, which Jensen said “underscores stenoparib’s unique mechanism of action as a dual inhibitor of both PARP and the WNT pathway.” According to the company, therapies to block only the PARP pathway have historically shown limited benefits in ovarian cancer patients who don’t carry a BRCA mutation.
The Phase 2 trial is still recruiting participants at sites in Oklahoma City and Seattle. Earlier this year, the company announced a new protocol for the study aimed at supporting future studies that could serve as the basis for applications seeking approval.
“We look forward to further exploring the game-changing potential of stenoparib through the ongoing enrollment of patients in our new Phase 2 trial protocol expressly enrolling PROC or platinum-ineligible patients,” Jensen said. “These data will help deepen and solidify the durable clinical benefit and extended overall survival stenoparib may provide and will support our attempts to accelerate stenoparib toward FDA [U.S. Food and Drug Administration] approval.”
The FDA recently granted fast track status to stenoparib. This designation aims to speed the development of therapies that have the potential to fill unmet needs for serious medical diseases.
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