Oncolytics Biotech庐 Highlights Strong Efficacy and Translational Data in Metastatic Colorectal Cancer; Will Advance Regulatory Pathway Discussions
Oncolytics Biotech (NASDAQ: ONCY) reported significant clinical and translational data from three metastatic colorectal cancer (mCRC) studies for its immunotherapy drug pelareorep. In the REO 022 trial, pelareorep combined with FOLFIRI and bevacizumab showed remarkable results in KRAS mutant patients, achieving 16.6 months median progression-free survival (versus 5.7 months standard) and 27.0 months median overall survival (versus 11.2 months standard).
The GOBLET study's 3L mCRC Cohort 3, combining pelareorep with atezolizumab and TAS-102, met its efficacy endpoint with improved survival rates. Translational data from REO 022 and REO 013 studies confirmed pelareorep's mechanism of action, demonstrating viral replication and immune activation in tumors. The company plans to advance regulatory discussions and develop an investigator-sponsored trial for KRAS mutant mCRC patients.
Oncolytics Biotech (NASDAQ: ONCY) ha riportato dati clinici e traslazionali significativi provenienti da tre studi sul carcinoma colorettale metastatico (mCRC) per il suo immunoterapico pelareorep. Nel trial REO 022, pelareorep in combinazione con FOLFIRI e bevacizumab ha mostrato risultati notevoli nei pazienti con mutazione KRAS, raggiungendo una mediana di sopravvivenza libera da progressione di 16,6 mesi (contro 5,7 mesi dello standard) e una mediana di sopravvivenza globale di 27,0 mesi (contro 11,2 mesi dello standard).
Il braccio 3 del terzo linea (3L) dello studio GOBLET, che combinava pelareorep con atezolizumab e TAS-102, ha soddisfatto l'endpoint di efficacia mostrando tassi di sopravvivenza migliorati. I dati traslazionali dei trial REO 022 e REO 013 hanno confermato il meccanismo d'azione di pelareorep, evidenziando la replicazione virale e l'attivazione del sistema immunitario nei tumori. L'azienda intende avviare discussioni regolatorie e sviluppare uno studio sponsorizzato da investigatori per pazienti con mCRC e mutazione KRAS.
Oncolytics Biotech (NASDAQ: ONCY) inform贸 datos cl铆nicos y traslacionales significativos de tres estudios en c谩ncer colorrectal metast谩sico (mCRC) sobre su inmunoter谩pico pelareorep. En el ensayo REO 022, pelareorep combinado con FOLFIRI y bevacizumab mostr贸 resultados destacados en pacientes con mutaci贸n KRAS, alcanzando una supervivencia libre de progresi贸n mediana de 16,6 meses (frente a 5,7 meses est谩ndar) y una supervivencia global mediana de 27,0 meses (frente a 11,2 meses est谩ndar).
La cohorte 3 de 3L mCRC del estudio GOBLET, que combin贸 pelareorep con atezolizumab y TAS-102, cumpli贸 su objetivo de eficacia con tasas de supervivencia mejoradas. Los datos traslacionales de REO 022 y REO 013 confirmaron el mecanismo de acci贸n de pelareorep, demostrando replicaci贸n viral y activaci贸n inmune en los tumores. La compa帽铆a planea avanzar en las discusiones regulatorias y desarrollar un ensayo patrocinado por investigadores para pacientes con mCRC y mutaci贸n KRAS.
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Oncolytics Biotech (NASDAQ: ONCY) a publi茅 des donn茅es cliniques et translationnelles significatives issues de trois 茅tudes sur le cancer colorectal m茅tastatique (mCRC) concernant son immunoth茅rapeutique pelareorep. Dans l'essai REO 022, pelareorep associ茅 au FOLFIRI et au bevacizumab a montr茅 des r茅sultats remarquables chez les patients porteurs d'une mutation KRAS, avec une survie sans progression m茅diane de 16,6 mois (contre 5,7 mois pour le standard) et une survie globale m茅diane de 27,0 mois (contre 11,2 mois pour le standard).
La cohorte 3 en 3e ligne (3L) de l'茅tude GOBLET, combinant pelareorep avec atezolizumab et TAS-102, a atteint son crit猫re d'efficacit茅 avec des taux de survie am茅lior茅s. Les donn茅es translationnelles des 茅tudes REO 022 et REO 013 ont confirm茅 le m茅canisme d'action de pelareorep, d茅montrant une r茅plication virale et une activation immunitaire au sein des tumeurs. La soci茅t茅 pr茅voit d'avancer dans les 茅changes r茅glementaires et de d茅velopper un essai initi茅 par des investigateurs pour les patients mCRC porteurs d'une mutation KRAS.
Oncolytics Biotech (NASDAQ: ONCY) meldete bedeutende klinische und translationsbezogene Daten aus drei Studien zum metastasierten kolorektalen Krebs (mCRC) f眉r sein Immuntherapeutikum Pelareorep. Im REO 022-Studie zeigte Pelareorep in Kombination mit FOLFIRI und Bevacizumab bei KRAS-mutierten Patienten bemerkenswerte Ergebnisse und erreichte eine medianes progressionsfreies 脺berleben von 16,6 Monaten (gegen眉ber 5,7 Monaten Standard) und ein medianes Gesamt眉berleben von 27,0 Monaten (gegen眉ber 11,2 Monaten Standard).
Die 3.-Linien-Kohorte 3 der GOBLET-Studie, die Pelareorep mit Atezolizumab und TAS-102 kombinierte, erf眉llte ihren Wirksamkeitsendpunkt mit verbesserten 脺berlebenswerten. Translationsdaten aus REO 022 und REO 013 best盲tigten den Wirkmechanismus von Pelareorep und zeigten virale Replikation sowie Immunaktivierung in Tumoren. Das Unternehmen plant, regulatorische Gespr盲che voranzutreiben und eine von Forschern initiierte Studie f眉r KRAS-mutierte mCRC-Patienten zu entwickeln.
- Pelareorep showed 2.5x longer progression-free survival (16.6 vs 5.7 months) compared to standard treatment
- Overall survival more than doubled (27.0 vs 11.2 months) in KRAS mutant patients
- GOBLET study met predefined efficacy endpoint with improved survival rates
- Confirmed mechanism of action through viral replication and immune activation in tumors
- None.
Insights
Pelareorep shows remarkable 2.5x survival benefit in KRAS-mutant colorectal cancer with strong mechanistic validation, positioning for regulatory advancement.
The clinical data for pelareorep in metastatic colorectal cancer (mCRC) represents a potentially significant advancement in treating KRAS-mutant patients鈥攁 notoriously difficult-to-treat subgroup. The REO 022 trial showed pelareorep combined with FOLFIRI and bevacizumab achieved median PFS of 16.6 months versus 5.7 months with standard care, and median OS of 27.0 months versus 11.2 months鈥攁pproximately 2.5 times longer survival than current standard therapy.
What's particularly compelling is the translational data confirming pelareorep's mechanism of action in colorectal tumors. The virus demonstrably replicates within tumors and triggers immune activation, including dendritic cell maturation and CD8+ T cell recruitment. This immune conversion is critical because it transforms traditionally "cold" tumors into "hot" ones susceptible to immune attack, potentially explaining the dramatic survival improvements.
The GOBLET study results in third-line mCRC further validate pelareorep's efficacy, with the combination meeting predefined endpoints and achieving better disease control than historical benchmarks. The consistency across multiple trials strengthens the scientific case for pelareorep as a potential platform immunotherapy for GI cancers.
For context, KRAS mutations occur in approximately 40% of colorectal cancers and have historically predicted poor response to targeted therapies. The magnitude of benefit seen here鈥攊f confirmed in larger studies鈥攚ould represent one of the most significant advances in KRAS-mutant colorectal cancer treatment in years, addressing a major unmet medical need.
In KRAS mutant 2L mCRC, pelareorep delivers prolonged survival benefit with a median PFS and median OS approximately 2.5x the current standard of care
Translational data from multiple studies confirm pelareorep replication in CRC tumors and immune activation
Company to define regulatory pathway and advance potential IST in KRAS mutant CRC patient population
In the REO 022 trial, pelareorep in combination with FOLFIRI and bevacizumab achieved the following results in platinum refractory 2L mCRC KRAS mutant patients:
- Median progression-free survival ("PFS"): 16.6 months vs. 5.7 months with standard 2L regimen1
- Median overall survival ("OS"): 27.0 months vs. 11.2 months with standard 2L regimen1
In the GOBLET study's 3L mCRC Cohort 3, pelareorep combined with atezolizumab and TAS-102 met its predefined efficacy endpoint. The regimen achieved durable disease control and survival rates greater than historical benchmarks for 3L mCRC treated with TAS-102.
In the REO 022 trial and the REO 013 translational study, viral replication and immune activation were demonstrated in tumors from mCRC patients, including dendritic cell maturation and CD8+ T cell activation. These findings confirm pelareorep's mechanism of action, including its ability to modify mCRC tumors to be immune responsive and amenable to checkpoint inhibition.
"These studies validate pelareorep's mechanism of action and present a clear opportunity to accelerate the pursuit of a registration-enabled study in the underserved KRAS mutant subset of mCRC patients," said Jared Kelly, CEO of Oncolytics. "Given pelareorep's activity in this difficult-to-treat cancer and other RAS-mutated gastrointestinal ("GI") tumors, including metastatic pancreatic and anal cancers, we believe pelareorep is positioned to become the premier platform immunotherapy in the GI space."
"The efficacy data for pelareorep in the hard-to-treat KRAS mutant population of mCRC are very encouraging," said Dr. Sanjay Goel, professor and attending physician at Rutgers University. "We plan to initiate an investigator-sponsored trial to further explore pelareorep's promising potential in KRAS mutant mCRC, building on the robust immune activation demonstrated in REO 013 and the survival benefit seen in REO 022."
In addition to establishing an executable investigator-sponsored trial, the company plans to work with leading investigators and engage with regulators to define a clear path to registration in mCRC, including the design of a confirmatory study, leveraging the data in the KRAS mutant patient setting.
References:
1.听听听听听 Bennouna J. Lancet Oncol (14):29-37, 2013
About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered double-stranded RNA immunotherapeutic agent. Pelareorep has demonstrated promising 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 induces 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, both of which 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:听听or follow the Company on social media on 听and on X @.
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