Allarity Therapeutics Announces Presentation of Phase 2 Clinical Data from Ongoing Trial in Advanced Ovarian Cancer Patients at the 2025 Annual Meeting for the Society of Gynecologic Oncology
Allarity Therapeutics (NASDAQ: ALLR) presented new Phase 2 clinical data for stenoparib in advanced ovarian cancer at the SGO 2025 Annual Meeting. The trial focused on heavily pre-treated patients, with 14 out of 15 participants being platinum-resistant and one having primary platinum-refractory disease.
Key findings show that five patients maintained therapy beyond 4 months, with four exceeding 20 weeks. Notable outcomes include:
- One patient achieved a confirmed complete response lasting over 10 months
- Two patients remain on therapy after 17+ months
- The platinum-refractory patient stayed on therapy beyond 40 weeks
Significantly, stenoparib showed benefit in patients without BRCA mutations, potentially due to its unique dual mechanism inhibiting both PARP and Wnt pathway. The drug demonstrated good tolerability without typical bone marrow toxicity seen in first-generation PARP inhibitors.
Allarity Therapeutics (NASDAQ: ALLR) ha presentato nuovi dati clinici della Fase 2 per stenoparib nel cancro ovarico avanzato durante l'Annual Meeting SGO 2025. Lo studio si è concentrato su pazienti con precedenti trattamenti intensivi, con 14 su 15 partecipanti resistenti al platino e uno con malattia primaria refrattaria al platino.
I risultati chiave mostrano che cinque pazienti hanno mantenuto la terapia oltre 4 mesi, con quattro che hanno superato le 20 settimane. I risultati notevoli includono:
- Un paziente ha raggiunto una risposta completa confermata della durata di oltre 10 mesi
- Due pazienti sono rimasti in terapia dopo oltre 17 mesi
- Il paziente refrattario al platino ha continuato la terapia per oltre 40 settimane
Significativamente, stenoparib ha mostrato benefici nei pazienti senza mutazioni BRCA, potenzialmente grazie al suo unico meccanismo duale che inibisce sia PARP che la via Wnt. Il farmaco ha dimostrato una buona tollerabilità senza la tipica tossicità midollare osservata negli inibitori PARP di prima generazione.
Allarity Therapeutics (NASDAQ: ALLR) presentó nuevos datos clínicos de Fase 2 para stenoparib en cáncer de ovario avanzado en la Reunión Anual SGO 2025. El ensayo se centró en pacientes con tratamientos previos intensivos, con 14 de 15 participantes siendo resistentes al platino y uno con enfermedad primaria refractaria al platino.
Los hallazgos clave muestran que cinco pacientes mantuvieron la terapia más allá de 4 meses, con cuatro superando las 20 semanas. Los resultados notables incluyen:
- Un paciente logró una respuesta completa confirmada que duró más de 10 meses
- Dos pacientes permanecen en terapia después de más de 17 meses
- El paciente refractario al platino continuó la terapia más de 40 semanas
Significativamente, stenoparib mostró beneficios en pacientes sin mutaciones BRCA, potencialmente debido a su único mecanismo dual que inhibe tanto PARP como la vía Wnt. El fármaco demostró buena tolerabilidad sin la típica toxicidad de médula ósea observada en los inhibidores de PARP de primera generación.
Allarity Therapeutics (NASDAQ: ALLR)는 SGO 2025 연례 회의에서 진행성 난소암에 대한 stenoparib의 2상 임상 데이터를 발표했습니다. 이 시험은 15명의 참가자 중 14명이 백금 내성이며 1명이 1차 백금 불응성 질환을 가진 중증 치료 환자에 초점을 맞췄습니다.
주요 결과는 다섯 명의 환자가 4개월 이상 치료를 유지했다는 것을 보여주며, 네 명은 20주를 초과했습니다. 주목할 만한 결과는 다음과 같습니다:
- 한 환자가 10개월 이상 지속된 확인된 완전 반응을 달성했습니다
- 두 명의 환자가 17개월 이상 치료를 계속하고 있습니다
- 백금 불응성 환자가 40주 이상 치료를 지속했습니다
특히 stenoparib는 BRCA 변이가 없는 환자에게도 이점을 보여주었으며, 이는 PARP와 Wnt 경로를 모두 억제하는 독특한 이중 메커니즘 덕분일 수 있습니다. 이 약물은 1세대 PARP 억제제에서 보이는 전형적인 골수 독성 없이 좋은 내약성을 나타냈습니다.
Allarity Therapeutics (NASDAQ: ALLR) a présenté de nouvelles données cliniques de phase 2 pour le stenoparib dans le cancer de l'ovaire avancé lors de la réunion annuelle SGO 2025. L'essai s'est concentré sur des patients ayant subi de nombreux traitements, avec 14 sur 15 participants étant résistants au platine et un ayant une maladie primaire réfractaire au platine.
Les résultats clés montrent que cinq patients ont maintenu la thérapie au-delà de 4 mois, dont quatre ont dépassé les 20 semaines. Les résultats notables incluent:
- Un patient a atteint une réponse complète confirmée durant plus de 10 mois
- Deux patients restent en thérapie après plus de 17 mois
- Le patient réfractaire au platine est resté en thérapie au-delà de 40 semaines
De manière significative, le stenoparib a montré des bénéfices chez les patients sans mutations BRCA, probablement grâce à son mécanisme unique à double action inhibant à la fois PARP et la voie Wnt. Le médicament a démontré une bonne tolérance sans la toxicité médullaire typique observée avec les inhibiteurs de PARP de première génération.
Allarity Therapeutics (NASDAQ: ALLR) präsentierte neue klinische Daten der Phase 2 für Stenoparib bei fortgeschrittenem Eierstockkrebs auf der SGO-Jahrestagung 2025. Die Studie konzentrierte sich auf stark vorbehandelte Patienten, wobei 14 von 15 Teilnehmern platinresistent waren und einer eine primäre platinrefraktäre Erkrankung hatte.
Wichtige Ergebnisse zeigen, dass fünf Patienten die Therapie über 4 Monate aufrechterhielten, wobei vier über 20 Wochen hinausgingen. Bemerkenswerte Ergebnisse umfassen:
- Ein Patient erreichte eine bestätigte komplette Remission, die über 10 Monate anhielt
- Zwei Patienten bleiben nach mehr als 17 Monaten in Therapie
- Der platinrefraktäre Patient blieb über 40 Wochen in Therapie
Signifikant zeigte Stenoparib Vorteile bei Patienten ohne BRCA-Mutationen, möglicherweise aufgrund seines einzigartigen dualen Mechanismus, der sowohl PARP als auch den Wnt-Weg hemmt. Das Medikament zeigte eine gute Verträglichkeit ohne die typische Knochenmarkstoxizität, die bei PARP-Inhibitoren der ersten Generation beobachtet wird.
- Complete response achieved in one patient lasting over 10 months
- Two patients still on therapy after 17+ months
- Effective in both BRCA-mutant and non-mutant patients, expanding potential patient population
- Better tolerability profile compared to first-generation PARP inhibitors
- Unique dual mechanism of action (PARP/Wnt pathway inhibition)
- Some patients with very advanced disease progressed very quickly
- Heterogeneous patient population makes direct comparison to earlier studies impossible
- Trial to heavily pre-treated patients with 3+ prior therapies
Insights
Allarity Therapeutics' Phase 2 data for stenoparib in advanced ovarian cancer represents a meaningful clinical development in a challenging treatment landscape. The trial results demonstrate durable clinical benefit in platinum-resistant and refractory patients with therapeutic options, showing notable staying power with 5 patients remaining on therapy beyond 4 months, including a confirmed complete response lasting over 10 months.
What's particularly significant is stenoparib's efficacy in BRCA wild-type patients - a larger population typically unresponsive to first-generation PARP inhibitors. This suggests the drug's dual inhibition of both PARP and Wnt pathways provides a differentiated mechanism of action with broader applicability. The tolerability profile, notably the absence of typical bone marrow toxicity, could allow for longer treatment duration and improved quality of life.
The company's strategic decision to advance a narrower, more focused protocol targeting platinum-resistant patients who have progressed through only one additional line of therapy represents an optimized development pathway. By excluding patients with massive ascites who may progress rapidly, Allarity appears to be refining its approach to maximize success rates in subsequent trials - a calculated step toward potential regulatory approval for this dual-mechanism inhibitor in an area of significant unmet need.
Allarity's stenoparib data represents a potential commercial opportunity in the competitive ovarian cancer market where novel mechanisms are desperately needed. The reported clinical benefit in both BRCA-mutant and BRCA wild-type populations is commercially significant, as it substantially expands the potential patient population beyond the BRCA-mutant segment targeted by first-generation PARP inhibitors.
The durability signals - with two patients remaining on therapy beyond 17 months - indicate potential for meaningful progression-free survival advantages if confirmed in larger studies. This differentiation through dual PARP/Wnt inhibition could provide Allarity with a competitive edge in a market where most approved PARP inhibitors face increasing competition and patent cliffs.
The improved safety profile, particularly the absence of severe bone marrow toxicity, addresses a significant limitation of current PARP inhibitors that often require dose reductions or treatment discontinuations. For Allarity, a
- The Annual Meeting is the foremost educational and scientific
event for gynecologic oncologists - Stenoparib has shown clinical benefit in heavily pre-treated patients, including those with platinum-resistant and refractory ovarian cancer
- Findings may reflect stenoparib’s dual PARP/Wnt pathway inhibition
Boston (March 17, 2025)—Allarity Therapeutics, Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib—a differentiated dual PARP/Wnt pathway inhibitor— announced the presentation of new clinical data from its ongoing Phase 2 trial with stenoparib monotherapy in advanced Ovarian Cancer at the Society of Gynecologic Oncology (SGO) 2025 Annual Meeting on Women’s Cancer, held March 14-17 in Seattle, Washington. SGO is the world’s premier organization for professionals working to lessen the impact of gynecologic cancers, and the Annual Meeting on Women’s Cancer is the premier educational and scientific event for gynecologic oncologists and others dedicated to advancing gynecologic cancer care.
The poster presentation, titled "A Phase II Trial of Stenoparib (2X-121): A Novel Dual Tankyrase and PARP Inhibitor in Advanced, Recurrent Ovarian Cancer," will be presented by Dr. Fernanda B. Musa, MD, MS, Director of Clinical Trials in Gynecologic Oncology, Providence-Swedish Cancer Institute.
- Session: Poster Tour Group 14: Clinical Trials Impacting Future Therapies
- Date/Time: Monday, March 17, 10:30 a.m. PST
The poster presents data from the first Phase 2 study of stenoparib in advanced ovarian cancer and the first stenoparib study ever to dose twice daily. The study exclusively enrolled patients who had been previously treated with three or more lines of therapy and included patients with especially difficult-to-treat disease. Fourteen of the fifteen enrolled were platinum-resistant, while one patient had primary platinum-refractory disease that did not respond to first-line chemotherapy. There are very few effective treatment options for patients with platinum-resistant and refractory ovarian cancer, who unfortunately tend to have their disease recur within an average of three months. In this study, five patients stayed on therapy longer than four months, with four of these staying on beyond 20 weeks. Importantly, one patient showed a confirmed complete response (i.e., absence of measurable disease) that lasted more than 10 months. The patient with primary platinum-refractory disease remained on therapy beyond 40 weeks. Two patients remain on therapy currently—now more than 17 months.
The data also revealed significant clinical benefit in patients who typically do not get benefit from first-generation PARP inhibitors—those without mutations in the DNA repair gene, BRCA. One of the two patients still on therapy, now more than 17 months, did not have a BRCA mutation or other deficit in homologous DNA repair. Benefit in these BRCA wild-type patients may reflect the unique, dual therapeutic action of stenoparib in inhibiting not only PARP but also the Wnt pathway—a pathway activated in ovarian, colon, and other advanced cancers.
Key Findings:
- First study to dose stenoparib twice daily optimizing inhibition of PARP and Tankyrase across every 24-hour period.
- First stenoparib study to show potential durable clinical benefit in platinum-resistant and refractory patients.
- Data continue to show that stenoparib is well-tolerated and does not elicit the bone marrow toxicity typical of first-generation PARP inhibitors.
- Study shows clinical benefit across distinct genetic backgrounds including in both BRCA-mutant patients and in BRCA wild-type (non-mutated) patients, a larger patient group than those with BRCA mutation.
- Study supports the unique mechanism of action for stenoparib, which inhibits PARP and the Wnt oncogenic pathway.
- Study sets the stage for the newly announced protocol to evaluate stenoparib monotherapy dosed twice daily in platinum-resistant patients.
Dr. Fernanda B. Musa, MD, MS, site investigator for the study, commented, “This remains a challenging disease with limited therapies for patients who have already undergone many prior lines of treatment and who have been declared platinum-resistant or platinum-refractory. The findings from this study suggest that stenoparib may offer a new, well-tolerated therapeutic approach for a broader group of patients, including those with BRCA wild-type disease, who historically have had fewer options. It is a privilege to present these data at SGO 2025 and to share our findings with esteemed colleagues dedicated to advancing gynecologic oncology research.”
Thomas Jensen, Chief Executive Officer of Allarity Therapeutics, stated, “These results are foundational for us as they show stenoparib monotherapy can provide durable clinical benefit to very heavily pre-treated patients, both platinum-resistant and refractory. These data also show clinical benefit in patients both with and without BRCA mutations, or defects in homologous DNA damage repair, and may reflect the unique dual action of stenoparib on both PARP and Tankyrase targets. The data also continue to show that stenoparib is well-tolerated and does not show the bone marrow toxicity of earlier PARP inhibitors. All in all, the results of this exploratory phase 2 study have helped us to craft a new protocol designed with Dr. Fernanda Musa, Dr. Kathleen Moore, and other ovarian cancer thought leaders that will deepen and enrich our understanding of stenoparib’s durable clinical benefit—even in heavily pre-treated patients, enhance our understanding of its unique mechanism of action and accelerate the advance of stenoparib toward regulatory approval.”
Given the relatively heterogeneous patient population in this study, there are no direct comparisons to earlier studies. Importantly, this exploratory trial allowed enrollment of patients with very advanced disease, including massive ascites, following multiple prior lines of therapy. Some of these patients progressed very quickly in the study. The recently announced phase 2 protocol trial was expressly designed to narrow in on patients with platinum-resistant disease who have progressed through only a single, additional line of chemotherapy after the emergence of platinum resistance and who are without active evidence of ascites.
The poster presentation will be available on March 17 at 7:00 a.m. CT on Allarity’s website under the Scientific Publications section.
About Stenoparib
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.
About Allarity Therapeutics
Allarity Therapeutics, Inc. (NASDAQ: ALLR) is a clinical-stage biopharmaceutical company dedicated to developing personalized cancer treatments. The Company is focused on development of stenoparib, a novel PARP/tankyrase inhibitor for advanced ovarian cancer patients, using its DRP® technology to develop a companion diagnostic that can be used to select those patients expected to derive the greatest clinical benefit from stenoparib. Allarity is headquartered in the U.S., with a research facility in Denmark, and is committed to addressing significant unmet medical needs in cancer treatment. For more information, visit www.allarity.com.
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Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements provide the Company’s current expectations or forecasts of future events. The words “anticipates,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predicts,” “project,” “should,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements include, but are not limited to, expectations regarding the presentation of stenoparib Phase 2 trial data at the SGO 2025 Annual Meeting and its potential implications for future clinical development. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to multiple risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, to the successful delivery and reception of the stenoparib Phase 2 data presentation at the SGO 2025 Annual Meeting and its impact on ongoing and planned trials. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in our Form S-1/A registration statement filed on April 17, 2024, our Form 10-K annual report on file with the Securities and Exchange Commission (the “SEC”) and our Form 10-Q quarterly report filed with the SEC on November 14, 2024, available at the SEC’s website at www.sec.gov, and as well as discussions of potential risks, uncertainties and other important factors in the Company’s subsequent filings with the SEC. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information unless required by law.
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Company Contact:
investorrelations@allarity.com
Media Contact:
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tsp@carrotize.com
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FAQ
What are the key results from Allarity's (ALLR) Phase 2 stenoparib trial in ovarian cancer?
How does stenoparib's effectiveness compare in BRCA mutant vs non-mutant ovarian cancer patients?
What distinguishes stenoparib from first-generation PARP inhibitors in ovarian cancer treatment?
What is the significance of stenoparib's twice-daily dosing in the Phase 2 trial?
