Oncolytics Biotech® to Present Compelling New Efficacy and Safety Data in Anal and Pancreatic Cancers at 2025 ASCO GI Symposium
Oncolytics Biotech (NASDAQ: ONCY) has announced significant developments in their pelareorep-based cancer treatments, to be presented at the 2025 ASCO Gastrointestinal Cancers Symposium. The company reported compelling results in two key areas:
In anal cancer, the combination of pelareorep with checkpoint inhibitor atezolizumab showed a 33% objective response rate in twelve evaluable patients, significantly outperforming historical checkpoint inhibitor monotherapy rates of 10-24%. Notably, one patient maintained a complete response for over 15 months.
In pancreatic cancer, following previous positive results with gemcitabine and nab-paclitaxel combination, new safety data supports pelareorep's compatibility with modified FOLFIRINOX treatment. This expansion was supported by a $5 million PanCAN grant, and the Data Safety Monitoring Board has approved continued patient enrollment without modifications.
The GOBLET study's anal cancer cohort has met its Stage 1 efficacy criteria and is proceeding to Stage 2, enrolling 18 additional patients. The treatment shows promising tumor-infiltrating lymphocyte expansion in responding patients.
Oncolytics Biotech (NASDAQ: ONCY) ha annunciato sviluppi significativi nei trattamenti oncologici basati su pelareorep, che saranno presentati al Simposio ASCO sui Tumori Gastrointestinali 2025. L'azienda ha riportato risultati notevoli in due aree chiave:
Nel cancro anale, la combinazione di pelareorep con l'inibitore di checkpoint atezolizumab ha mostrato un tasso di risposta obiettiva del 33% in dodici pazienti valutabili, superando significativamente i tassi storici di monoterapia con inibitori di checkpoint, che si attestano tra il 10% e il 24%. È importante notare che un paziente ha mantenuto una risposta completa per oltre 15 mesi.
Per quanto riguarda il cancro pancreatico, dopo risultati positivi precedenti con la combinazione gemcitabina e nab-paclitaxel, nuovi dati sulla sicurezza supportano la compatibilità di pelareorep con il trattamento FOLFIRINOX modificato. Questa espansione è stata sostenuta da una sovvenzione di $5 milioni di PanCAN, e il Comitato per la Sicurezza dei Dati ha approvato l'iscrizione continua dei pazienti senza modifiche.
Il coorte di cancro anale dello studio GOBLET ha soddisfatto i criteri di efficacia della Fase 1 e sta procedendo alla Fase 2, arruolando ulteriori 18 pazienti. Il trattamento mostra un'espansione promettente dei linfociti infiltranti tumorali nei pazienti rispondenti.
Oncolytics Biotech (NASDAQ: ONCY) ha anunciado desarrollos significativos en sus tratamientos contra el cáncer basados en pelareorep, que se presentarán en el Simposio ASCO de Cánceres Gastrointestinales 2025. La empresa reportó resultados contundentes en dos áreas clave:
En cáncer anal, la combinación de pelareorep con el inhibidor de punto de control atezolizumab mostró una tasa de respuesta objetiva del 33% en doce pacientes evaluables, superando significativamente las tasas históricas de monoterapia con inhibidores de punto de control, que oscilan entre el 10% y el 24%. Cabe destacar que un paciente mantuvo una respuesta completa durante más de 15 meses.
En cuanto al cáncer pancreático, tras resultados positivos previos con la combinación de gemcitabina y nab-paclitaxel, nuevos datos de seguridad respaldan la compatibilidad de pelareorep con el tratamiento de FOLFIRINOX modificado. Esta expansión fue apoyada por una subvención de $5 millones de PanCAN, y el Comité de Monitoreo de Seguridad de Datos aprobó la continuación de la inscripción de pacientes sin modificaciones.
La cohorte de cáncer anal del estudio GOBLET ha cumplido con los criterios de eficacia de la Etapa 1 y está avanzando a la Etapa 2, reclutando 18 pacientes adicionales. El tratamiento muestra una prometedora expansión de linfocitos infiltrantes tumorales en los pacientes que responden.
온콜리틱스 바이오텍 (NASDAQ: ONCY)은 2025년 ASCO 소화기암 심포지엄에서 발표할 새로운 발전을 발표했습니다. 이 회사는 두 가지 주요 분야에서 주목할 만한 결과를 보고했습니다:
항문암의 경우, pelareorep와 체크포인트 억제제인 atezolizumab의 조합은 열두 명의 평가 가능한 환자에서 33%의 객관적 반응률을 보여주었으며, 기존 체크포인트 억제제 단독 치료의 10-24%를 크게 초과했습니다. 특히, 한 환자는 15개월 이상 완전한 반응을 유지했습니다.
췌장암의 경우, gemcitabine과 nab-paclitaxel 조합에서 긍정적인 결과를 바탕으로, 새로운 안전성 데이터는 pelareorep의 수정된 FOLFIRINOX 치료와의 호환성을 지원합니다. 이 확장은 PanCAN의 500만 달러 지원금으로 지원받았으며, 데이터 안전성 모니터링 위원회는 수정 없이 환자 모집을 계속할 것을 승인했습니다.
GOBLET 연구의 항문암 집단은 1단계 효능 기준을 충족하여 2단계로 나아가고 있으며, 18명의 추가 환자를 모집하고 있습니다. 치료는 반응하는 환자에서 종양 침윤 림프구의 증가 가능성을 보여줍니다.
Oncolytics Biotech (NASDAQ: ONCY) a annoncé des développements significatifs dans ses traitements contre le cancer basés sur pelareorep, qui seront présentés lors du Symposium ASCO sur les Cancers Gastro-intestinaux 2025. L'entreprise a rapporté des résultats convaincants dans deux domaines clés :
Dans le cas du cancer anal, la combinaison de pelareorep avec l'inhibiteur de point de contrôle atezolizumab a montré un taux de réponse objective de 33 % chez douze patients évaluables, dépassant ainsi de manière significative les taux de monothérapie avec inhibiteurs de point de contrôle historiques de 10 à 24 %. Il est à noter qu'un patient a maintenu une réponse complète pendant plus de 15 mois.
Pour le cancer du pancréas, après des résultats positifs antérieurs avec la combinaison gemcitabine et nab-paclitaxel, de nouvelles données de sécurité soutiennent la compatibilité de pelareorep avec le traitement FOLFIRINOX modifié. Cette expansion a été soutenue par une subvention de 5 millions de dollars de PanCAN, et le Conseil de Surveillance de la Sécurité des Données a approuvé la poursuite de l'inscription des patients sans modifications.
La cohorte de cancer anal de l'étude GOBLET a satisfait aux critères d'efficacité de la Phase 1 et passe à la Phase 2, recrutant 18 patients supplémentaires. Le traitement montre une expansion prometteuse des lymphocytes infiltrants tumoraux chez les patients répondants.
Oncolytics Biotech (NASDAQ: ONCY) hat bedeutende Entwicklungen in ihren auf pelareorep basierenden Krebstherapien bekannt gegeben, die auf dem ASCO-Symposium für gastrointestinalen Krebs 2025 präsentiert werden. Das Unternehmen berichtete über überzeugende Ergebnisse in zwei wichtigen Bereichen:
Bei Analkrebs zeigte die Kombination von pelareorep mit dem Checkpoint-Inhibitor Atezolizumab eine objektive Ansprechraten von 33% bei zwölf bewertbaren Patienten, was die historischen Monotherapiemethoden von Checkpoint-Inhibitoren mit Raten von 10-24% erheblich übertrifft. Bemerkenswert ist, dass ein Patient eine vollständige Remission von mehr als 15 Monaten aufrechterhalten hat.
Im Bereich Bauchspeicheldrüsenkrebs unterstützten neue Sicherheitsdaten die Verträglichkeit von pelareorep mit der modifizierten FOLFIRINOX-Behandlung, nach vorherigen positiven Ergebnissen mit der Kombination von Gemcitabin und nab-Paclitaxel. Diese Erweiterung wurde durch einen Zuschuss von 5 Millionen Dollar von PanCAN unterstützt, und das Data Safety Monitoring Board hat die fortgesetzte Patienteneinschreibung ohne Änderungen genehmigt.
Die Analkrebs-Kohorte der GOBLET-Studie hat die Wirksamkeitskriterien der Phase 1 erfüllt und schreitet zur Phase 2 fort, in der 18 zusätzliche Patienten eingeschlossen werden. Die Behandlung zeigt vielversprechende Expansion von tumor-infiltrierenden Lymphozyten bei den ansprechenden Patienten.
- None.
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Pelareorep combination therapy shows continued meaningful improvement over checkpoint inhibitors alone in anal cancer patients
Pelareorep-based therapy demonstrates strong safety profile with new chemotherapy regimen in pancreatic cancer patients
Thomas Heineman, M.D., Ph.D., Chief Medical Officer for Oncolytics Biotech, commented, "The posters that will be presented at the symposium later this week continue to show pelareorep's compelling potential in gastrointestinal cancers. In relapsed anal cancer, the efficacy signal that was initially reported continues to outperform historical control trials with the inclusion of additional patients. Importantly, the complete response we observed previously continued beyond the 12 months initially reported. Together, these results point to a clinically meaningful synergy between pelareorep and checkpoint inhibitors like atezolizumab. In pancreatic cancer, pelareorep previously demonstrated a strong efficacy signal when administered with gemcitabine, nab-paclitaxel and atezolizumab. Our new safety data indicate its ability to also be combined with modified FOLFIRINOX, thus expanding its potential to benefit patients with metastatic pancreatic cancer. We will continue to provide updates on the safety and efficacy of pelareorep-based combination therapy from these cohorts as they become available."
"I am quite pleased by these recent updates from the GOBLET study as they continue to provide potential new treatment options for patients in need of alternatives while maintaining a manageable safety profile," said Dirk Arnold, M.D., Ph.D., Director of Asklepios Tumorzentrum Hamburg, and primary investigator of the GOBLET trial. "I've been especially impressed with the ability of pelareorep-based therapies to work across multiple challenging cancer indications and with multiple standards of care, including chemotherapy and checkpoint inhibitors, so I look forward to additional data readouts that can help improve the treatment paradigm."
Abstract Number: 6
Title: GOBLET platform study: Preliminary safety and tumor response results for the relapsed anal carcinoma cohort in patients treated with pelareorep and atezolizumab.
Presentation Type: Poster
Session Title: Poster Session C: Cancers of the Colon, Rectum, and Anus
Session Date and Time: January 25, 2025, 7:00 - 7:55 a.m. PT
The fourth cohort of the GOBLET study is evaluating pelareorep combined with the checkpoint inhibitor atezolizumab in patients with second-line or later unresectable squamous cell carcinoma of the anal canal (SCCA). The treatment combination met the pre-defined efficacy success criteria for Stage 1 of its Simon two-stage design, and Stage 2 enrollment of 18 additional evaluable patients has begun. Updated results from this cohort show that four of twelve evaluable patients achieved a partial response for an objective response rate of
Abstract Number: 730
Title: GOBLET study: Results of the safety run-in for first-line metastatic pancreatic ductal adenocarcinoma (PDAC) patients treated with pelareorep + modified FOLFIRINOX +/- atezolizumab.
Presentation Type: Poster
Session Title: Poster Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract
Session Date and Time: January 24, 2025, 11:30 a.m. – 1:00 p.m. PT
A promising efficacy signal in metastatic pancreatic ductal adenocarcinoma (PDAC) was previously observed for the combination of pelareorep, gemcitabine, nab-paclitaxel, and atezolizumab. To expand the potential of pelareorep to benefit PDAC patients, and after discussion with key opinion leaders, a cohort was added to the GOBLET study to evaluate pelareorep combined with modified FOLFIRINOX (mFOLFIRINOX) both with and without atezolizumab. This cohort is being funded by a
Abstracts from the ASCO Gastrointestinal Cancers Symposium are currently available on the event website, which can be accessed by clicking here.
References
- Rao S, et al. Phase II study of retifanlimab in patients (pts) with squamous carcinoma of the anal canal (SCAC) who progressed following platinum-based chemotherapy. Annals of Oncology. 2020 September. doi: https://doi.org/10.1016/j.annonc.2020.08.2272.
- Marabelle A, et al. Pembrolizumab for previously treated advanced anal squamous cell carcinoma: results from the non-randomised, multicohort, multicentre, phase 2 KEYNOTE-158 study. Lancet Gastroenterol Hepatol. 2022 May;7(5):446-454. doi: 10.1016/S2468-1253(21)00382-4.
- Lonardi S, et al. Randomized phase II trial of avelumab alone or in combination with cetuximab for patients with previously treated, locally advanced, or metastatic squamous cell anal carcinoma: the
CARACAS study. J Immunother Cancer. 2021 November;9(11):e002996. doi: 10.1136/jitc-2021-002996. PMID: 34815354; PMCID: PMC8611452.
About GOBLET
The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 17 centers in
- Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic pancreatic cancer patients;
- Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients;
- Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients
- Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients; and
- Pelareorep in combination with mFOLFIRINOX with and without atezolizumab in newly diagnosed metastatic PDAC patients.
Any cohort meeting pre-specified efficacy criteria in Stage 1 may be advanced to Stage 2 and enroll additional patients.
About AIO
AIO-Studien-gGmbH (AIO) emerged from the study center of the medical oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally.
About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.
Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For further information, please visit: www.oncolyticsbiotech.com or follow the company on social media on LinkedIn and on X @oncolytics.
Tecentriq® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.
This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; our plans to provide updates on the safety and efficacy of pelareorep-based combinations therapy; our expectation that additional data from the fourth cohort of our Stage 2 GOBLET study will provide a sufficiently strong efficacy signal to move the treatment regimen into a registration-enabling study; our plans to advance pelareorep to registration-enabling studies for the treatment of breast and pancreatic cancers; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. We may incur expenses or delays relating to events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and
Company Contact
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FAQ
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