Business
Allarity’s Early Phase 2 Stenoparib Data Indicates Clinical Benefit in Women with Advanced Ovarian Cancer Selected with DRP® Companion Diagnostic
All evaluable participants, with prior PARP inhibitor therapy and chemotherapy, showed significant tumor shrinkage including one complete response Early data
About this update from Allarity Therapeutics, Inc.
[{"type":"text","content":" All evaluable participants, with prior PARP inhibitor therapy and chemotherapy, showed significant tumor shrinkage including one complete response Early data follows Phase 2 dose optimization change from once-daily to twice-daily Boston (December 5, 2023) — Allarity Therapeutics, Inc. (“Allarity” or the “Company”) (Nasdaq: ALLR), a clinical-stage pharmaceutical company developing novel oncology therapeutics together with drug-specific DRP® companion diagnostics for personalized cancer care, today announced encouraging initial results from its ongoing Phase 2 clinical trial evaluating the efficacy of its PARP inhibitor, stenoparib, in women with advanced ovarian cancer (AOC). Of the five evaluable patients included in the initial data analysis, one patient experienced a complete response and the other four demonstrated stable disease. Investigators prescreened women with AOC using Allarity’s DRP®-Stenoparib CDx, a complex transcriptomic signature comprising 414 mRNA biomarkers indicative of response/resistance to the drug. Each woman was assigned a DRP®-score, and those with scores above 50%, which suggested a higher likelihood of benefiting from treatment with stenoparib, were selected for treatment. Selected patients received stenoparib in a twice daily (BID) dosing regimen (200 mg morning, 400 mg evening) under a change in protocol, implemented earlier in the year, from prior once-daily dosing of 600 mg. Allarity implemented the protocol change to optimize the drug exposure taking into account the half-life of stenoparib in patients. Of the 22 patients screened with the DRP®-Stenoparib CDx, 17 DRP® positive patients were identified. Eleven women have entered treatment, and among the five evaluable participants assessed up to the data evaluation cut-off, there were early signs of clinical benefit in all cases: One patient experienced a complete response (CR) by scan (to be confirmed by second scan) and by decreased levels of CA125 (a biomarker of AOC).One patient experienced stable disease with tumor shrinkage of 19%.One patient experienced stable disease for more than 24 weeks with tumor shrinkage of 11%.Two patients experienced stable disease with tumor shrinkage of 8%. All five patients had previously been treated with another PARP inhibitor. All five patients remain in treatment with stenoparib and the four that did not ha...