Oncolytics Biotech® Announces Update for Potential First-Line Pancreatic Cancer Registration Study
Oncolytics Biotech (NASDAQ: ONCY) announced updates for its planned registration-directed clinical trial in first-line pancreatic ductal adenocarcinoma (PDAC). The company will meet with the FDA in mid-November 2025 to discuss study details.
The proposed trial features a three-arm design evaluating: 1) Gemcitabine + nab-paclitaxel (GnP) control, 2) GnP + pelareorep, and 3) GnP + pelareorep + checkpoint inhibitor. The study's primary endpoint is Overall Survival, with planned interim analysis for early efficacy assessment.
Previous post-hoc analysis showed pelareorep plus chemotherapy achieved 22% two-year survival rate compared to 9% with chemotherapy alone. The company aims to establish pelareorep as the first approved immunotherapy in first-line pancreatic cancer.
Oncolytics Biotech (NASDAQ: ONCY) ha fornito aggiornamenti sullo studio clinico pianificato per la prima linea di adenocarcinoma pancreatico duttale (PDAC). L'azienda incontrerà la FDA a metà novembre 2025 per discutere i dettagli dello studio.
Lo studio proposto prevede una progettazione a tre bracci che valuta: 1) controllo con Gemcitabina + nab-paclitaxel (GnP), 2) GnP + pelareorep e 3) GnP + pelareorep + inibitore del checkpoint. L’endpoint primario è la sopravvivenza globale, con un’analisi intermedia prevista per valutare l’efficacia precoce.
Un’analisi post-hoc precedente ha mostrato che pelareorep più chechemioterapia ha raggiunto una sopravvivenza a due anni del 22% rispetto al 9% con la chemioterapia da sola. L’azienda punta a stabilire pelareorep come prima immunoterapia approvata in prima linea per il cancro pancreatico.
Oncolytics Biotech (NASDAQ: ONCY) anunció actualizaciones sobre su ensayo clínico orientado a la aprobación en primera línea para el adenocarcinoma ductal pancreático (PDAC). La empresa se reunirá con la FDA a mediados de noviembre de 2025 para discutir los detalles del estudio.
El ensayo propuesto presenta un diseño de tres brazos que evalúa: 1) control con Gemcitabina + nab-paclitaxel (GnP), 2) GnP + pelareorep y 3) GnP + pelareorep + inhibidor del checkpoint. El objetivo primario del estudio es la Sobrevida Global, con un análisis interino previsto para evaluar la eficacia temprana.
Un análisis post-hoc previo mostró que pelareorep más quimioterapia logró una tasa de supervivencia a dos años del 22% frente al 9% con quimioterapia sola. La compañía pretende establecer pelareorep como la primera inmunoterapia aprobada en primera línea para el cáncer de páncreas.
Oncolytics Biotech (NASDAQ: ONCY)가 제1선 췌장관협샘종 PDAC에 대한 예정된 임상시험에 대한 업데이트를 발표했습니다. 회사는 2025년 11월 중순에 FDA와 만남에서 연구 세부사항을 논의할 예정입니다.
제안된 임상시험은 삼팔 디자인으로 구성되며, 1) 제미시타빈 + nab-파클리탁셀(GnP) 대조군, 2) GnP + pelareorep, 3) GnP + pelareorep + 체크포인트 억제제 를 평가합니다. 연구의 주요 평가 지표는 Overall Survival이며, 조기 효능 평가를 위한 중간 분석이 예정되어 있습니다.
이전의 후향 분석에서 pelareorep와 화학요법의 병용은 2년 생존율 22%를 보였고, 화학요법 단독은 9%였습니다. 회사는 pelareorep를 1선 췌장암에서 최초로 승인받는 면역치료제로 확립하는 것을 목표로 합니다.
Oncolytics Biotech (NASDAQ: ONCY) a publié des mises à jour sur son essai clinique dirigé vers l’enregistrement en première ligne pour l’adénocarcinome pancréatique ductal (PDAC). L’entreprise rencontrera la FDA à la mi-novembre 2025 pour discuter des détails de l’étude.
L’essai proposé présente une conception à trois bras évaluant : 1) contrôle Gemcitabine + nab-paclitaxel (GnP), 2) GnP + pelareorep et 3) GnP + pelareorep + inhibiteur de checkpoint. Le critère d’évaluation principal est la survie globale, avec une analyse intermédiaire prévue pour évaluer l’efficacité précoce.
Une analyse post-hoc précédente a montré que pelareorep + chimiothérapie a atteint une taux de survie à deux ans de 22% contre 9% avec la chimiothérapie seule. L’entreprise vise à établir pelareorep comme la première immunothérapie approuvée en première ligne pour le cancer du pancréas.
Oncolytics Biotech (NASDAQ: ONCY) gab Updates zu seiner geplanten registrierungsrelevanten klinischen Studie in der ersten Behandlungslinie beim pankreatischen duktalen Adenokarzinom (PDAC) bekannt. Das Unternehmen wird mitte November 2025 ein Treffen mit der FDA abhalten, um Studiendetails zu besprechen.
Die vorgeschlagene Studie sieht ein Drei-Arme-Design vor, das Folgendes bewertet: 1) Gemcitabin + nab-paclitaxel (GnP) als Kontrollgruppe, 2) GnP + pelareorep und 3) GnP + pelareorep + Checkpoint-Inhibitor. Als primärer Endpunkt gilt das Overall Survival, mit einer geplanten Zwischenanalyse zur frühen Wirksamkeitsbewertung.
Eine frühere Post-hoc-Analyse zeigte, dass pelareorep plus Chemotherapie eine 2-Jahres-Überlebensrate von 22% erreichte, verglichen mit 9% bei Chemotherapie allein. Das Unternehmen will pelareorep als erste zugelassene Immuntherapie in der ersten Linie beim pankreatischen Krebs etablieren.
Oncolytics Biotech (NASDAQ: ONCY) أعلنت عن تحديثات لبرنامجها التجريبي المعتمد للتسجيل في خط العلاج الأول لسرطان البنكرياس القنيوي القِشري (PDAC). ستلتقي الشركة مع FDA في منتصف نوفمبر 2025 لمناقشة تفاصيل الدراسة.
التجربة المقترحة تتمتع بـ
أظهرت تحليل بعد الحدث سابقًا أن pelareorep مع العلاج الكيميائي حقق معدل بقاء على قيد الحياة لمدة عامين 22% مقارنة بـ 9% مع العلاج الكيميائي وحده. تسعى الشركة إلى تثبيت Pelareorep كأول علاج مناعي معتمد في الخط الأول لسرطان البنكرياس.
Oncolytics Biotech (NASDAQ: ONCY)宣布了其计划用于第一线胰腺导管腺癌（PDAC）的注册相关临床试验更新。公司将于2025年11月中旬与FDA会面，讨论研究细节。
该提议的试验采用三臂设计，评估：1) 吉西他滨 + nab-紫杉醇（GnP）对照组，2) GnP + pelareorep，3) GnP + pelareorep + 检查点抑制剂。研究的主要终点为总体生存期，计划进行中期分析以评估早期疗效。
先前的事后分析显示，pelareorep 与化疗联合实现了
- Previous data showed significant improvement in two-year survival rate (22% vs 9%) with pelareorep
- Well-designed three-arm registration trial with potential for FDA approval
- Opportunity to become first approved immunotherapy for first-line pancreatic cancer
- FDA meeting still pending in November 2025
- Final trial design not yet approved by regulators
Insights
Oncolytics advances pelareorep toward registration trial for pancreatic cancer with impressive survival data supporting potential approval pathway.
The announcement of a registration-directed study design for pelareorep represents a significant milestone in Oncolytics' clinical development strategy. The proposed three-arm trial design is particularly noteworthy for its methodological robustness, incorporating both a control arm and two experimental arms that will evaluate pelareorep both with standard chemotherapy and with checkpoint inhibition.
Most compelling is the preliminary data supporting this trial - a
The selection of Overall Survival as the primary endpoint is strategically sound for regulatory purposes, as it represents the gold standard for oncology drug approvals. The planned interim efficacy analysis creates an opportunity for early signal detection that could accelerate development timelines if positive.
Pancreatic ductal adenocarcinoma remains among the deadliest cancers with minimal improvement in outcomes over decades. Standard gemcitabine/nab-paclitaxel therapy offers limited benefit. If successful, pelareorep would address a critical unmet need as potentially the first approved immunotherapy in first-line PDAC treatment - particularly significant as pancreatic cancer has historically been resistant to immunotherapeutic approaches.
Key Elements of the Proposed Registration Study
- Three-arm design - patients will be randomized to receive:
1. Gemcitabine + nab-paclitaxel (GnP) control arm.
2. GnP + pelareorep.
3. GnP + pelareorep + checkpoint inhibitor (CPI). - Primary endpoint: Overall Survival (OS).
- Statistical rigor: The trial will be powered to detect statistical significance between the investigational arms and the control arm.
- Planned interim analysis: An interim efficacy analysis will be incorporated to enable early assessment of potential clinical benefit.
This proposed design builds on a post-hoc, pooled clinical analysis, which found that the addition of pelareorep to chemotherapy achieved an approximate
"We are excited to advance this potential registration-directed study in first-line pancreatic cancer with a well-powered, three-arm design," said Jared Kelly, Chief Executive Officer of Oncolytics. "By evaluating pelareorep with chemotherapy and in combination with checkpoint inhibition, we expect to position this program to deliver meaningful data for patients and regulators alike. We believe that potential partners will recognize the possibility this trial design presents to establish pelareorep as the first approved immunotherapy in first-line pancreatic cancer - a transformative milestone in oncology."
About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an investigational intravenously delivered double-stranded RNA immunotherapeutic agent. Pelareorep has demonstrated encouraging results in multiple first-line pancreatic cancer studies, two randomized Phase 2 studies in metastatic breast cancer, and early-phase studies in anal and colorectal cancer. It is designed to induce anti-cancer immune responses by converting immunologically "cold" tumors "hot" through the activation of innate and adaptive immune responses.
The Company is advancing pelareorep in combination with chemotherapy and/or checkpoint inhibitors in metastatic pancreatic and breast cancers, of which both development programs have received Fast Track designation from the FDA, and other gastrointestinal tumors. Oncolytics is actively pursuing strategic partnerships to accelerate development and maximize commercial impact. For more about Oncolytics, please visit: www.oncolyticsbiotech.com or follow the Company on social media on LinkedIn and on X @oncolytics.
Forward-looking statements
This press release contains forward-looking statements, within the meaning of Section 21E of the
Company Contact
Jon Patton
Director of IR & Communication
jpatton@oncolytics.ca
Investor Relations for Oncolytics
Mike Moyer
LifeSci Advisors
+1-617-308-4306
mmoyer@lifesciadvisors.com
Media Contact for Oncolytics
Owen Blaschak
LifeSci Communications
oblaschak@lifescicomms.com
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SOURCE Oncolytics Biotech® Inc.
FAQ
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