Allarity Therapeutics Presents New Phase 2 Clinical Data for Stenoparib/2X-121 Showing Landmark Median Overall Survival Has Now Surpassed 25 Months
Allarity Therapeutics (NASDAQ: ALLR) has presented groundbreaking Phase 2 clinical data for stenoparib/2X-121 at the AACR Special Conference on Ovarian Cancer. The trial's Kaplan-Meier analyses revealed that median Overall Survival (mOS) has exceeded 25 months in platinum-resistant and refractory ovarian cancer patients.
Key highlights include two patients continuing therapy beyond 24 months, including one with wild-type BRCA gene. The drug shows clinical benefits regardless of BRCA status, distinguishing it from first-generation PARP inhibitors. Notably, stenoparib's mOS of >25 months significantly outperforms recent FDA-approved therapies' mOS of 16-16.5 months for platinum-resistant ovarian cancer (PROC) patients.
The drug demonstrates a favorable safety profile with reduced myelotoxicity compared to earlier PARP inhibitors, and its dual inhibition of PARP1/2 and WNT pathway shows promise for broader patient benefit.
Allarity Therapeutics (NASDAQ: ALLR) ha presentato dati clinici innovativi di fase 2 per stenoparib/2X-121 alla conferenza speciale AACR sul cancro ovarico. Le analisi di Kaplan-Meier dello studio hanno mostrato che la mediana della sopravvivenza globale (mOS) ha superato i 25 mesi nei pazienti con cancro ovarico resistente al platino e refrattario.
Principali highlight includono due pazienti che continuano la terapia oltre i 24 mesi, incluso uno con gene BRCA di tipo wild-type. Il farmaco mostra benefici clinici indipendentemente dallo stato di BRCA, distinguendosi dai PARP inibitori di prima generazione. Da notare, la mOS di stenoparib >25 mesi supera significativamente la mOS delle terapie recentemente approvate dalla FDA, che si attestano a 16–16,5 mesi per i pazienti PROC.
Il farmaco mostra un profilo di sicurezza favorevole con una mielotossicità ridotta rispetto ai precedenti inibitori di PARP, e la sua doppia inibizione di PARP1/2 e della via WNT lascia intravedere benefici per una gamma più ampia di pazienti.
Allarity Therapeutics (NASDAQ: ALLR) ha presentado datos clínicos innovadores de fase 2 para stenoparib/2X-121 en la Conferencia Especial de AACR sobre cáncer de ovario. Los análisis de Kaplan-Meier del ensayo mostraron que la mediana de supervivencia global (mOS) superó los 25 meses en pacientes con cáncer de ovario resistente al platino y refractario.
Aspectos clave: dos pacientes continúan la terapia más allá de los 24 meses, incluido uno con BRCA de tipo salvaje. El fármaco muestra beneficios clínicos independientemente del estado de BRCA, lo que lo distingue de los inhibidores de PARP de primera generación. Notablemente, mOS de stenoparib >25 meses supera significativamente el mOS de 16-16,5 meses de terapias aprobadas por la FDA recientemente para pacientes PROC.
El fármaco presenta un perfil de seguridad favorable con menor mielotoxicidad frente a inhibidores de PARP anteriores, y su inhibición doble de PARP1/2 y de la vía WNT promete beneficios para un grupo más amplio de pacientes.
Allarity Therapeutics(NASDAQ: ALLR)가 AACR 특별회의에서 난소암에 대한 stenoparib/2X-121의 혁신적인 2상 임상 데이터를 제시했습니다. 연구의 Kaplan-Meier 분석에 따르면 표준화된 Overall Survival(mOS)이 25개월을 넘었다고 합니다.
핵심 하이라이트로는 24개월 이상 치료를 지속하는 두 명의 환자들이 포함되며, BRCA 유전자가 정상인 환자도 포함됩니다. BRCA 상태와 무관하게 임상적 이점을 보이며, 1세대 PARP 억제제와 차별화됩니다. 특히 stenoparib의 mOS가 25개월 이상으로 FDA 승인 최근 치료법들의 PROC 환자에서의 mOS 16~16.5개월을 크게 상회합니다.
약물은 안전성 프로파일이 우수하고, 이전 PARP 억제제에 비해 골수독성도 낮으며, PARP1/2와 WNT 경로의 이중 억제가 더 넓은 환자군의 이익으로 이어질 가능성이 있습니다.
Allarity Therapeutics (NASDAQ: ALLR) a présenté des données cliniques révolutionnaires de phase 2 pour le stenoparib/2X-121 lors de la conférence spéciale AACR sur le cancer de l’ovaire. Les analyses de Kaplan-Meier de l’essai ont révélé que la médiane de survie globale (mOS) a dépassé 25 mois chez les patientes atteintes d’un cancer de l’ovaire résistant au platine et réfractaire.
Points clés : deux patientes poursuivent le traitement au-delà de 24 mois, dont une porte le BRCA en statut sauvage. Le médicament montre des bénéfices cliniques indépendamment du statut BRCA, ce qui le distingue des inhibiteurs de PARP de première génération. Fait notable, le mOS du stenoparib >25 mois dépasse largement le mOS des thérapies récemment approuvées par la FDA pour les patientes PROC, à 16–16,5 mois.
Le médicament présente un profil de sécurité favorable avec une myélotoxicité réduite par rapport aux premiers inhibiteurs de PARP, et son inhibition double de PARP1/2 et de la voie WNT laisse entrevoir des bénéfices pour un plus grand nombre de patientes.
Allarity Therapeutics (NASDAQ: ALLR) hat bahnbrechende Phase-2-Daten zu stenoparib/2X-121 auf der AACR-Sonderkonferenz zum Ovarialkarzinom präsentiert. Die Kaplan-Meier-Analysen der Studie zeigten, dass die mediane Gesamtüberlebenszeit (mOS) bei platinresistenten und refraktären Ovarialkrebspatientinnen 25 Monate überstieg.
Wichtige Highlights: zwei Patientinnen setzen die Therapie über 24 Monate fort, darunter eine mit BRCA-Wildtyp. Das Medikament zeigt klinische Vorteile unabhängig vom BRCA-Status und unterscheidet sich damit von PARP-Inhibitoren der ersten Generation. Bemerkenswert übertrifft der mOS von stenoparib mit >25 Monaten die mOS der jüngsten FDA-zugelassenen Therapien für PROC-Patientinnen deutlich (16–16,5 Monate).
Das Medikament weist ein günstiges Sicherheitsprofil mit reduzierter Myelotoxicität im Vergleich zu früheren PARP-Inhibitoren auf, und seine doppelte Hemmung von PARP1/2 sowie der WNT-Weg verspricht Vorteile für eine breitere Patientengruppe.
Allarity Therapeutics (NASDAQ: ALLR) قدمت بيانات كلاينية من المرحلة الثانية رائدة لـ stenoparib/2X-121 في المؤتمر الخاص للجمعية الأمريكية لعلم السرطان حول سرطان المبيض. كشفت تحليلات كابلان-مير للصلابة أن وسيط البقاء على قيد الحياة الإجمالي (mOS) قد تجاوز 25 شهراً لدى مرضى سرطان المبيض المقاوم للبلاتين والمتراجع عن العلاج.
النقاط الأساسية: اثنان من المرضى يستمران في العلاج لأكثر من 24 شهراً، من بينهما مريض يحمل BRCA بالنوع البري. الدواء يُظهر فائدة سريرية بغض النظر عن حالة BRCA، وهذا يميزه عن مثبطات PARP من الجيل الأول. من الجدير بالذكر أن mOS لـ stenoparib الذي يتجاوز 25 شهراً يتفوق بشكل ملحوظ على mOS العلاجات المعتمدة مؤخراً من FDA لمرضى PROC، حيث تبلغ 16-16.5 شهراً.
يُظهر الدواء ملف سلامة مفضل مع انخفاض في سمّية نخاعية مقارنة بمثبطات PARP السابقة، كما أن تثبيط PARP1/2 ومسار WNT معاً يعد بمنافع لأوسع فئة من المرضى.
Allarity Therapeutics (NASDAQ: ALLR) 在 AACR 乳腺卵巢癌特別会议上公布了 stenoparib/2X-121 的开创性二期临床数据。研究的 Kaplan-Meier 分析显示，在铂耐受性和难治性卵巢癌患者中，总体生存期中位数（mOS）已超过 25 个月。
要点包括：两名患者治疗持续超过 24 个月，其中一名携带 BRCA 基因野生型。该药对 BRCA 状态无关，显示出临床获益，与第一代 PARP 抑制剂区分开来。值得注意的是，stenoparib 的 mOS（>25 个月）显著超过最近 FDA 批准治疗在 PROC 患者中的 mOS 16–16.5 个月。该药物显示出有利的安全性特征，与早期 PARP 抑制剂相比，骨髓抑制性降低，并且其对 PARP1/2 与 WNT 通路的双重抑制显示出更广泛患者获益的前景。
- Median Overall Survival (mOS) exceeds 25 months, nearly 10 months longer than recent FDA-approved therapies
- Clinical benefits shown in both BRCAwt and BRCAmut patients, expanding potential patient population
- Two patients remain on therapy for over 24 months, including one with platinum-refractory disease
- Favorable safety profile with significantly less myelotoxicity than first-generation PARP inhibitors
- Median Overall Survival has not been formally reached yet
- Trial is still in Phase 2, requiring further studies before potential FDA approval
Insights
Allarity's stenoparib shows impressive 25+ month survival in platinum-resistant ovarian cancer, outperforming current standards by ~9 months.
The new Phase 2 data for stenoparib (2X-121) represents a potentially significant advancement in treating platinum-resistant ovarian cancer (PROC). The median Overall Survival (mOS) exceeding 25 months is particularly noteworthy when compared to the current standard of care and recently approved therapies, which typically achieve only 16-16.5 months mOS. This 9-month survival advantage could be clinically meaningful in this difficult-to-treat patient population.
What makes these results especially compelling is the drug's efficacy across both BRCA-mutated and BRCA wild-type patients. Traditional PARP inhibitors primarily benefit patients with BRCA mutations, but stenoparib's dual mechanism as both a PARP inhibitor and WNT pathway inhibitor appears to extend its utility to a broader patient population. This is evidenced by a BRCA wild-type patient remaining on therapy for over 24 months.
The durability of response is also remarkable, with two patients continuing treatment beyond 24 months, and a platinum-refractory patient (typically with very poor prognosis) surviving more than two years post-enrollment. The favorable safety profile with reduced myelotoxicity compared to first-generation PARP inhibitors addresses a significant limitation that led to market withdrawals in 2022.
The patient selection strategy using the Stenoparib-specific Drug Response Predictor (DRP®) score may be contributing to these positive outcomes by identifying patients most likely to benefit. While these results are promising, it's important to note that the sample size appears limited, and the final mOS has not yet been formally reached. The ongoing enrollment in their new Phase 2 protocol will be crucial to confirm these findings and potentially support accelerated FDA approval efforts.
- Kaplan-Meier analyses show for the first time that median Overall Survival exceeds 25 months for Platinum Resistant
and Refractory Ovarian Cancer Patients receiving stenoparib/2X-121 twice daily
- Two patients continue on therapy now more than 24 months
- Clinical Benefit Evident in patients with BRCAwt as well as BRCAmut genetics
- Data presented at the American Association for Cancer Research (AACR)
7th Biennial Special Conference on Ovarian Cancer, Denver CO
TARPON SPRINGS, Fla., 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—today announced 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) 7th Biennial Special Conference on Ovarian Cancer, held September 19–21, 2025, at the Grand Hyatt Denver in Denver, Colorado. The poster is available via the Scientific Publications section of the Company’s website.
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 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 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.
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, statements regarding the potential efficacy, safety, clinical benefit, and regulatory advancement of stenoparib (2X-121); the Company’s expectations for its ongoing and future clinical trials, including patient enrollment and data readouts; and the potential for FDA approval or other regulatory milestones. 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, risks related to clinical development, including the risk that future clinical results may not be consistent with prior data; delays or difficulties in patient enrollment; the Company’s reliance on third parties to conduct its trials; regulatory decisions by the FDA or other authorities; the Company’s ability to obtain and maintain regulatory approvals; and the sufficiency of the Company’s capital resources and need for additional financing. 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 10-K annual report filed with the Securities and Exchange Commission (the “SEC”) on March 31, 2025, 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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Carrotize PR & Communications
+45 6062 9390
tsp@carrotize.com
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FAQ
What are the latest Phase 2 results for Allarity Therapeutics' stenoparib (ALLR)?
How does stenoparib's survival rate compare to other ovarian cancer treatments?
What makes Allarity's stenoparib different from other PARP inhibitors?
What is the safety profile of stenoparib in ovarian cancer treatment?
Can patients without BRCA mutations benefit from stenoparib treatment?
