Stenoparib Receives FDA Fast Track Designation in Advanced Ovarian Cancer

The novel treatment was evaluated in a phase 2 trial and saw a clinical benefit in patients with advanced ovarian cancer.

The FDA has granted fast track designation to stenoparib (2X-121) for patients with advanced ovarian cancer, according to a press release from Allarity Therapeutics.¹

Stenoparib, a dual PARP and WNT pathway inhibitor, is orally available. This treatment is unique in the fact that it inhibits PART and blocks WNT pathway activation.

“We are pleased that the FDA has granted fast track designation to stenoparib,” Thomas Jensen, chief executive officer of Allarity Therapeutics, said in the press release.¹ “This recognition underscores the significant unmet need facing women with advanced ovarian cancer and reflects the potential of stenoparib to meaningfully improve treatment outcomes. We look forward to engaging closely with the FDA as we advance this program.”

In June 2025, the drug’s developer announced that a second patient had received stenoparib and enrolled in a phase 2 trial that was evaluating patients with advanced, recurrent, platinum-resistant, or platinum-ineligible ovarian cancer.² Previous results showed patients who were dosed twice daily with stenoparib achieved a durable clinical benefit with favorable tolerability.

Additionally, the Drug Response Predictor-DRP® Companion Diagnostic, has been shown to provide a statistically significant prediction of clinical treatment outcomes across clinical studies. Of note, when patients are screened prior to treatment, they have a better likelihood of responding to a specific drug.

In May 2024, Allarity Therapeutics announced the early discontinuation of a phase 2 trial (NCT03878849) evaluating stenoparib.³ The trial of stenoparib twice daily showed clinical benefit that included tumor shrinkage and long-term disease stability. In the press release, the company noted the results showed clear clinical proof regarding stenoparib use in this population, which will allow the company the work on developing a follow-up trial with FDA-regulatory intent.

"Based on the substantial clinical benefit observed in the early stages of the trial, we have achieved proof of concept results that surpassed our initial expectations and provided the critical insights we were seeking," Thomas Jensen, chief executive officer of Allarity Therapeutics, said in the press release.¹ "Concluding the trial now is the most effective way to re-allocate our financial resources to develop a follow-on trial with the fastest route to regulatory submission for stenoparib. The patients enrolled in this trial are heavily pretreated, having undergone multiple prior treatments, often including PARP inhibitors. It is highly noteworthy that stenoparib, used in patients selected with the DRP® [companion diagnostic], has delivered sustained clinical benefit for such patients who are heavily pre-treated in the trial.”

The phase 2 trial is estimated to enroll 40 patients.⁴ The primary end point was to evaluate the optimal dose of stenoparib as a single agent and as a 600 mg dose vs an 800 mg daily dose. The secondary end point included the clinical benefit rate, progression-free survival, overall survival, disease control rate, and objective response rate.

Patients were either given 600 mg of stenoparib with 200 mg in the morning plus 400 mg in the evening or 800 mg with 400 mg in the morning plus 400 mg in the evening.

Patients were included in the trial if they had histologically or cytologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal cancer; platinum-resistant disease; no more than 1 line of therapy in the platinum-resistant or platinum-ineligible setting; and have measurable disease by CT or MRI.

Patients were excluded if they had platinum-refractory disease, concurrent chemotherapy, another malignancy apart from any stage I or II cancer deemed cured by the investigator, or active infection that required parenteral or oral antibiotics.

References

1. Allarity Therapeutics granted FDA fast track designation for stenoparib for the treatment of advanced ovarian cancer. News release. Allarity Therapeutics. August 26, 2025. Accessed August 26, 2025. https://tinyurl.com/2zz8v6mt
2. Allarity Therapeutics announces dosing of second patient in new phase 2 trial of stenoparib in advanced ovarian cancer. News release. Allarity Therapeutics. June 27, 2025. Accessed August 26, 2025. https://tinyurl.com/2s4yvz84
3. Allarity Therapeutics’ stenoparib shows clear clinical benefit and achieves significant milestone with early conclusion of phase 2 trial in advanced ovarian cancer. News release. Allarity Therapeutics. May 2, 2024. Accessed August 26, 2025. https://tinyurl.com/duwr9sp3
4. Investigation of the anti-tumor effect of 2x-121 in patients with recurrent, advanced ovarian cancer. ClinicalTrials.gov. Updated May 8, 2025. Accessed August 26, 2025. https://tinyurl.com/mrync6ky