CatalYm to Present Phase 2 Bladder Cancer Trial Results at ESMO Congress

CatalYm will present primary results from its Phase 2 GDFATHER-NEO trial at ESMO Congress 2025. The trial investigates visugromab, a GDF-15 neutralizing antibody, in combination with nivolumab in muscle-invasive bladder cancer patients. Additionally, a second oral presentation will cover long-term follow-up data from the GDFATHER-01 Phase 1/2 trial demonstrating deep and durable remissions in heavily pretreated cancer patients.

Allarity Therapeutics, Inc. (NASDAQ: ALLR) has announced significant clinical data from its ongoing Phase 2 trial of stenoparib (2X-121) for advanced ovarian cancer patients at the American Association for Cancer Research (AACR) 7th Biennial Special Conference on Ovarian Cancer, held September 19–21, 2025, in Denver, Colorado. The data presented at the conference highlight the potential of stenoparib as a dual PARP and WNT pathway inhibitor, demonstrating a median Overall Survival (mOS) exceeding 25 months for patients with platinum-resistant or refractory ovarian cancer.

The trial enrolled patients with advanced ovarian cancer who had either platinum-resistant or refractory disease and showed a Stenoparib-specific Drug Response Predictor (DRP®) score above 50. The Kaplan-Meier analysis, which was the first to report median Overall Survival from the trial, indicated that the mOS has not yet been reached and currently exceeds 25 months. Notably, two patients have been on therapy for more than 24 months, including one with a wild-type BRCA gene—a genetic background that typically precludes benefit from PARP inhibitors. The data also showed clinical benefit in patients with both BRCA wild-type and BRCA mutant genetics.

Thomas Jensen, Chief Executive Officer of Allarity Therapeutics, commented on the significance of the findings, stating, “These emerging clinical results suggest that stenoparib may offer meaningful extended survival benefit for patients with advanced, platinum-resistant ovarian cancer—a population with historically poor outcomes and limited treatment options.” Jensen further emphasized the durability of clinical benefit, including in heavily pre-treated patients and those with BRCA wild-type status, underscoring stenoparib’s unique mechanism of action as a dual inhibitor of both PARP and the WNT pathway.

The median Overall Survival of 25 months reported in the trial is nearly 10 months longer than the mOS reported for the most recent FDA approvals and advances in therapy for platinum-resistant ovarian cancer patients. This underscores stenoparib’s potential to meaningfully improve patient outcomes and aligns with the FDA’s recent guidance on the assessment of Overall Survival as the most meaningful and objective endpoint for oncology drug approval.

Allarity Therapeutics has two ongoing Phase 2 trial protocols for stenoparib in ovarian cancer patients. The first protocol, which enrolled patients who had received 2+ lines of therapy, has been closed to further enrollment but continues for the enrolled patients who are still receiving benefit from stenoparib administration. An amended protocol, designed to enroll only platinum-resistant or platinum-ineligible patients, began enrolling patients this summer to accelerate the clinical development of stenoparib toward FDA approval.

The company’s DRP® technology was used to select patients with a high likelihood of benefiting from stenoparib, enhancing the therapeutic benefit rate. The DRP® platform, which has shown statistically significant predictions of clinical outcomes across dozens of clinical studies, was used to identify patients with a sufficiently high DRP score.

Allarity Therapeutics is committed to addressing significant unmet medical needs in cancer treatment and is headquartered in the U.S. with a research facility in Denmark. For more information, visit www.allarity.com.