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Allarity Therapeutics Halts Ovarian Cancer Trial on Better-Than-Expected Results

NEW YORK – Allarity Therapeutics on Thursday said it is discontinuing a Phase II trial of its PARP inhibitor stenoparib in ovarian cancer because the treatment has shown clear clinical benefit, providing sufficient proof of concept to accelerate its plans for a registrational trial.

In the Phase II trial, Allarity has been evaluating stenoparib as a monotherapy in about 60 patients with advanced ovarian cancer who have received two or more previous chemotherapy regimens, including potential treatment with other PARP inhibitors. Investigators used Allarity's companion diagnostic, the Drug Response Predictor (DRP), to select patients with the highest likelihood of deriving clinical benefit from stenoparib. Although the trial is being terminated, treatment of patients already enrolled will continue.

In early results reported in March, one of the five evaluable patients in the trial had a complete response and the other four had stable disease. The patient with a complete response had been on treatment for 10 months, and all five had experienced a clinical benefit for at least 20 weeks.

The tumor-agnostic DRP examines mRNA expression profiles from patient biopsies to identify those with a high likelihood of benefiting from a specific drug. It can be used across tumor types and is patented for more than 70 anti-cancer drugs.

"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 that we were seeking," Allarity CEO Thomas Jensen said in a statement. "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 Boston-based company recently reorganized its pipeline to focus solely on stenoparib, deprioritizing two other clinical programs.