On September 22, 2025 Allarity Therapeutics, Inc. ("Allarity" or the "Company") (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib (2X-121)—a differentiated, dual PARP and WNT pathway inhibitor, reported that Dr Jeremy Graff, President and Chief Development Officer for Allarity Therapeutics, presented new and updated clinical data from the ongoing Phase 2 clinical trial in advanced ovarian cancer patients at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 7th Biennial Special Conference on Ovarian Cancer, held September 19–21, 2025, at the Grand Hyatt Denver in Denver, Colorado (Press release, Allarity Therapeutics, SEP 22, 2025, View Source [SID1234656153]). The poster is available via the Scientific Publications section of the Company’s website.
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The presentation showcased the first Kaplan-Meier analysis for median Overall Survival (mOS) from the Company’s ongoing Phase 2 trial that enrolled patients with advanced ovarian cancer, all of whom had either platinum-resistant or refractory disease and had tumors showing a Stenoparib-specific Drug Response Predictor (DRP) score above 50. Notably, these data provide the first evidence that stenoparib, when given twice daily, may extend patient survival. The mOS has not been formally reached yet and now exceeds 25 months. Two patients actively remain on therapy now more than 24 months, with one of these two patients carrying a wild-type BRCA gene—a genetic background that typically precludes benefit from PARP inhibitors. Notably, one patient with primary platinum-refractory disease remains alive more than two years after enrollment—a clinical outcome that is highly uncommon in this population.
"These emerging clinical results presented at the AACR (Free AACR Whitepaper) 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," said Thomas Jensen, Chief Executive Officer of Allarity Therapeutics. "Importantly, the durability of clinical benefit—including in BRCA wild-type and heavily pre-treated patients—underscores stenoparib’s unique mechanism of action as a dual inhibitor of both PARP and the WNT pathway. Given the FDA’s recent proclamations emphasizing the need to assess Overall Survival, 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 mOS reported for the most recent FDA approvals and advances in therapy for PROC patients. 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. 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 approval."
A preliminary Kaplan-Meier (K-M) analysis of overall survival presented at this conference indicates that mOS has not yet been reached, with the current K-M estimate now exceeding 25 months, based on a median follow-up time of nearly 22 months. For context, the most recent clinical advances and FDA approved therapies for the treatment of PROC patients have shown mOS of approximately 16-16.5 months, an improvement versus the 11.5-13 months mOS of standard chemotherapy. This underscores stenoparib’s potential to meaningfully improve patient outcomes and dovetails with the FDA’s recently published draft guidance (Approaches to Assessment of Overall Survival in Oncology Clinical Trials, August 2025), which reaffirms overall survival as the most meaningful and objective endpoint for oncology drug approval.
The study population includes heavily pre-treated patients, many of whom had previously received PARP inhibitors, chemotherapy, immunotherapy, and antibody-drug conjugates (ADCs). Stenoparib continues to show a favorable safety profile, with significantly less myelotoxicity than typically observed with earlier-generation PARP inhibitors. This is especially relevant in light of the 2022 market withdrawal of first-generation PARP inhibitors in heavily pre-treated ovarian cancer, due to lack of demonstrated long-term survival benefit—emphasizing the need for therapies that may meaningfully extend overall survival. Moreover, the updated clinical data continue to show that stenoparib may provide clinical benefit in patients regardless of BRCA status, possibly reflecting the dual inhibition of PARP1/2 and the WNT pathway and distinguishing stenoparib from 1st generation PARP inhibitors.
About Stenoparib/2X-121
Stenoparib is an orally available, small-molecule dual-targeted inhibitor of PARP1/2 and tankyrase 1/2. At present, tankyrases are attracting significant attention as emerging therapeutic targets for cancer, principally due to their role in regulating the WNT signaling pathway. Aberrant WNT/β-catenin signaling has been implicated in the development and progression of numerous cancers. By inhibiting PARP and blocking WNT pathway activation, stenoparib’s unique therapeutic action shows potential as a promising therapeutic for many cancer types, including ovarian cancer. Allarity has secured exclusive global rights for the development and commercialization of stenoparib, which was originally developed by Eisai Co. Ltd. and was formerly known under the names E7449 and 2X-121. Allarity has two ongoing Phase 2 trial protocols for stenoparib in Ovarian Cancer patients. In the first, patients who had had 2+ lines of therapy were enrolled on stenoparib and given drug twice daily. This protocol has been closed to further enrollment but continues for the enrolled patients who are still receiving benefit from stenoparib administration. The updated data from this study were presented at this AACR (Free AACR Whitepaper) special conference on advances in Ovarian Cancer. Note that, as these data are from an ongoing trial, analyses may change as the study fully matures. An amended protocol designed expressly to capitalize on the emerging clinical experience with stenoparib in platinum resistant patients began enrolling patients this summer. This amended protocol enrolls only platinum resistant or platinum-ineligible patients and is designed to accelerate the clinical development of stenoparib toward FDA approval.
About the Drug Response Predictor – DRP Companion Diagnostic
Allarity uses its drug-specific DRP to select those patients who, by the gene expression signature of their cancer, may have a high likelihood of benefiting from a specific drug. By screening patients before treatment, and only treating those patients with a sufficiently high, drug-specific DRP score, the therapeutic benefit rate may be enhanced. The DRP method builds on the comparison of sensitive vs. resistant human cancer cell lines, including transcriptomic information from cell lines, combined with clinical tumor biology filters and prior clinical trial outcomes. DRP is based on messenger RNA expression profiles from patient biopsies. The DRP platform has shown an ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients across dozens of clinical studies (both retrospective and prospective). The DRP platform, which may be useful in all cancer types and is patented for dozens of anti-cancer drugs, has been extensively published in the peer-reviewed literature.