Oncolytics Biotech® Reports Favorable Results for BRACELET-1 Breast Cancer Study Reinforcing Path to Funding of a Registration-Enabling Study
Oncolytics Biotech Inc. (NASDAQ: ONCY) reported positive results from its BRACELET-1 Phase 2 study evaluating pelareorep in HR+/HER2- advanced or metastatic breast cancer patients. Key findings include:
1. Median overall survival (OS) not reached in the pelareorep + paclitaxel arm, with over half of patients alive at study end.
2. Estimated median OS of at least 32 months for pelareorep + paclitaxel vs 18 months for paclitaxel alone.
3. Two-year survival rate of 64% for pelareorep + paclitaxel vs 33% for paclitaxel alone.
4. Median progression-free survival (PFS) of 12.1 months for pelareorep + paclitaxel vs 6.4 months for paclitaxel alone.
These results, along with the previous IND-213 study, support the potential of pelareorep-based combination therapy in advanced breast cancer. Oncolytics Biotech is now seeking funding for a registration-enabling study.
Oncolytics Biotech Inc. (NASDAQ: ONCY) ha riportato risultati positivi dal suo studio di Fase 2 BRACELET-1 che valuta pelareorep in pazienti con cancro al seno avanzato o metastatico HR+/HER2-. I principali risultati includono:
1. La sopravvivenza globale mediana (OS) non è stata raggiunta nel braccio pelareorep + paclitaxel, con oltre la metà dei pazienti ancora vivi al termine dello studio.
2. OS mediana stimata di almeno 32 mesi per pelareorep + paclitaxel rispetto a 18 mesi per paclitaxel da solo.
3. Tasso di sopravvivenza a due anni del 64% per pelareorep + paclitaxel rispetto al 33% per paclitaxel da solo.
4. Sopravvivenza libera da progressione mediana (PFS) di 12,1 mesi per pelareorep + paclitaxel rispetto a 6,4 mesi per paclitaxel da solo.
Questi risultati, insieme allo studio IND-213 precedente, sostengono il potenziale della terapia combinata a base di pelareorep nel cancro al seno avanzato. Oncolytics Biotech sta ora cercando finanziamenti per uno studio abilitante alla registrazione.
Oncolytics Biotech Inc. (NASDAQ: ONCY) reportó resultados positivos de su estudio de Fase 2 BRACELET-1 que evalúa pelareorep en pacientes con cáncer de mama avanzado o metastásico HR+/HER2-. Los hallazgos clave incluyen:
1. La mediana de supervivencia general (OS) no se alcanzó en el brazo de pelareorep + paclitaxel, con más de la mitad de los pacientes vivos al final del estudio.
2. Mediana de OS estimada de al menos 32 meses para pelareorep + paclitaxel frente a 18 meses para paclitaxel solo.
3. Tasa de supervivencia a dos años del 64% para pelareorep + paclitaxel frente al 33% para paclitaxel solo.
4. Mediana de supervivencia libre de progresión (PFS) de 12.1 meses para pelareorep + paclitaxel frente a 6.4 meses para paclitaxel solo.
Estos resultados, junto con el estudio IND-213 anterior, respaldan el potencial de la terapia combinada basada en pelareorep en el cáncer de mama avanzado. Oncolytics Biotech ahora busca financiamiento para un estudio que habilite el registro.
온콜리틱스 바이오텍(주) (NASDAQ: ONCY)는 HR+/HER2- 진행성 또는 전이성 유방암 환자에서 pelareorep를 평가하는 BRACELET-1 2상 연구에서 긍정적인 결과를 보고했습니다. 주요 발견은 다음과 같습니다:
1. pelareorep + paclitaxel 군에서 전반적인 생존율의 중앙값(OS)이 도달하지 않았으며 연구 종료 시 점검된 환자 중 절반 이상이 생존하고 있었습니다.
2. pelareorep + paclitaxel의 추정 중앙 OS는 최소 32개월로, paclitaxel 단독의 18개월과 비교됩니다.
3. pelareorep + paclitaxel의 2년 생존율은 64%로, paclitaxel 단독의 33%와 비교 됩니다.
4. pelareorep + paclitaxel의 중앙 진행없는 생존(PFS)은 12.1개월이며, paclitaxel 단독의 6.4개월과 비교됩니다.
이러한 결과는 이전 IND-213 연구와 함께 pelareorep 기반의 병용 요법이 진행성 유방암에서 잠재력을 지닌다는 것을 뒷받침합니다. 온콜리틱스 바이오텍은 현재 등록을 위한 연구 자금을 찾고 있습니다.
Oncolytics Biotech Inc. (NASDAQ: ONCY) a rapporté des résultats positifs de son étude de Phase 2 BRACELET-1 qui évalue pelareorep chez des patients atteints de cancer du sein avancé ou métastatique HR+/HER2-. Les principales conclusions incluent :
1. La survie globale médiane (OS) n'a pas été atteinte dans le bras pelareorep + paclitaxel, avec plus de la moitié des patients encore en vie à la fin de l'étude.
2. OS médiane estimée d'au moins 32 mois pour pelareorep + paclitaxel contre 18 mois pour paclitaxel seul.
3. Taux de survie à deux ans de 64 % pour pelareorep + paclitaxel contre 33 % pour paclitaxel seul.
4. Survie sans progression médiane (PFS) de 12,1 mois pour pelareorep + paclitaxel contre 6,4 mois pour paclitaxel seul.
Ces résultats, associés à l'étude IND-213 précédente, soutiennent le potentiel de la thérapie combinée à base de pelareorep dans le cancer du sein avancé. Oncolytics Biotech recherche maintenant un financement pour une étude facilitant l'enregistrement.
Oncolytics Biotech Inc. (NASDAQ: ONCY) meldete positive Ergebnisse aus der Phase-2-Studie BRACELET-1, die pelareorep bei Patienten mit HR+/HER2- fortgeschrittenem oder metastasiertem Brustkrebs evaluiert. Die wichtigsten Ergebnisse umfassen:
1. Die mediane Gesamtüberlebenszeit (OS) wurde in der pelareorep + Paclitaxel-Gruppe nicht erreicht, wobei über die Hälfte der Patienten am Ende der Studie noch lebte.
2. Geschätzte mediane OS von mindestens 32 Monaten für pelareorep + Paclitaxel im Vergleich zu 18 Monaten für Paclitaxel allein.
3. Zwei-Jahres-Überlebensrate von 64% für pelareorep + Paclitaxel im Vergleich zu 33% für Paclitaxel allein.
4. Median der progressionsfreien Überlebenszeit (PFS) von 12,1 Monaten für pelareorep + Paclitaxel im Vergleich zu 6,4 Monaten für Paclitaxel allein.
Diese Ergebnisse unterstützen zusammen mit der vorhergehenden IND-213-Studie das Potenzial der pelareorep-basierten Kombinationstherapie bei fortgeschrittenem Brustkrebs. Oncolytics Biotech sucht nun nach Finanzierung für eine die Zulassung unterstützende Studie.
- Median overall survival (OS) not reached in pelareorep + paclitaxel arm, with over 50% of patients alive at study end
- Estimated median OS of at least 32.1 months for pelareorep + paclitaxel vs 18.2 months for paclitaxel alone
- Two-year survival rate of 64% for pelareorep + paclitaxel vs 33% for paclitaxel alone
- Median progression-free survival (PFS) of 12.1 months for pelareorep + paclitaxel vs 6.4 months for paclitaxel alone
- Confirmed overall response rate (ORR) of 37.5% for pelareorep + paclitaxel vs 13.3% for paclitaxel alone
- Results support potential of pelareorep-based combination therapy in advanced breast cancer
- Positive clinical effects not observed in the study group that received avelumab
- Activation of cytotoxic T cells by pelareorep was suppressed by the addition of avelumab
Insights
The BRACELET-1 study results are highly encouraging for Oncolytics Biotech. The pelareorep + paclitaxel arm showed impressive survival benefits, with median overall survival (OS) not reached and
The BRACELET-1 results are clinically significant. The estimated median OS of
These results are positive for Oncolytics Biotech's financial outlook. The strong efficacy data from BRACELET-1, corroborating the earlier IND-213 study, significantly de-risks the company's lead program. With plans for a registration-enabling study, Oncolytics is moving closer to potential commercialization. The estimated US market of 55,000 patients represents a substantial commercial opportunity. However, investors should note that funding for the next study is still needed, which may require dilutive financing or partnerships. The competitive landscape, including new antibody-drug conjugates, will be important to monitor. If pelareorep reaches the market, its potential to extend survival by over a year could drive strong adoption and revenue. While significant hurdles remain, these results enhance Oncolytics' value proposition and could attract potential partners or acquirers.
- Overall survival (OS) results from BRACELET-1 corroborate results of previous randomized IND-213 breast cancer study
- Together, these two studies support the compelling potential of pelareorep-based combination therapy to benefit patients with advanced or metastatic HR+/HER2- breast cancer
- Oncolytics Biotech is moving forward to secure funding for a registration-enabling study of pelareorep-based therapy in advanced or metastatic breast cancer
- Over half of BRACELET-1 patients in the pelareorep + chemotherapy arm alive at study end
- Median OS in the pelareorep + chemotherapy arm not reached; median OS at least 32 months (estimated) vs 18 months for the control chemotherapy-only arm
Final BRACELET-1 Results
Final BRACELET-1 efficacy data were collected and analyzed two years after the last patient was enrolled as specified by the protocol. Results of the final BRACELET-1 analysis show that the median OS was not reached in the pelareorep + paclitaxel arm, as more than half of the patients in that arm remained alive at study end. In contrast, median OS for the paclitaxel monotherapy arm was 18.2 months, and the hazard ratio was 0.48 for pelareorep + paclitaxel vs. the paclitaxel monotherapy. Had study follow-up continued beyond two years, and patients survived only until the next planned visit (in four months), the median OS for patients in the pelareorep + paclitaxel arm would be 32.1 months. In accordance with these results, the two-year survival rate for patients in the pelareorep + paclitaxel arm was
Confirmed overall response rate (ORR) was
"The fact that the median overall survival was not reached because more than half the patients were still alive at the end of the study is a remarkable achievement for us," said Wayne Pisano, Interim CEO and Chair of Oncolytics' Board of Directors. "It shows just how promising pelareorep treatment can be for extending the lives of breast cancer patients. This is further exemplified by the near doubling of the 2-year survival rate for patients who received pelareorep combination therapy."
Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics, commented, "The overall survival and final progression-free survival results from the BRACELET-1 final analysis exceeded our expectations. In addition, our translational data strongly suggest that the OS benefit was linked to pelareorep's immunologic activity. Taken together, the BRACELET-1 results provide compelling support for the potential of pelareorep-based combination therapy to benefit patients with advanced or metastatic HR+/HER2- breast cancer. Moreover, these results substantiate the statistically significant near doubling of median overall survival observed in the earlier randomized IND-213 study in a similar patient population treated with pelareorep + chemotherapy compared to chemotherapy alone. Having recently discussed with the FDA key design elements for our next breast cancer study, in combination with the strong survival data from the BRACELET-1 and IND-213 studies, we are confident in our plan to conduct a registration-enabling study to assess pelareorep-based combination therapy in patients with advanced HR+/HER2- breast cancer."
Professor Martine J. Piccart, M.D., Ph.D. Université Libre de Bruxelles commented, "While there has been progress in the treatment of advanced and metastatic breast cancer, an unmet medical need remains. With the encouraging results of BRACELET-1 and the prior positive results of the IND-213 study, pelareorep should continue to be developed and evaluated in the clinical setting."
Final BRACELET-1 Results:
Paclitaxel (PTX) | PTX + Pelareorep | PTX + Pelareorep + | |
Confirmed ORR Over Course of Trial | 2 (13.3 %) | 6 (37.5 %) | 3 (17.6 %) |
Median PFS (months) | 6.4 ( | 12.1 ( | 6.4 ( |
PFS Hazard Ratio vs. PTX Monotherapy | - | 0.39 ( | 1.43 ( |
Median OS (months) | 18.2 | Not Reached | 21.7 |
Estimate: 32.11 | |||
OS Hazard Ratio vs. PTX Monotherapy | - | 0.48 ( | 1.08 ( |
24-month OS Rate | 33 % | 64 % | 39 % |
Notes:
CI: Confidence interval; NR: Not reached. | |||
Christophe Degois, VP of Business Development for Oncolytics commented, "With the evolving breast cancer treatment paradigm and the introduction of antibody-drug conjugate therapies, pelareorep has the potential to provide an important alternative for patients considering chemotherapy as their next treatment option. Upon thorough analysis of the HR+/HER2- metastatic breast treatment cancer landscape, we believe that pelareorep could have a substantial impact on around 55,000 patients in the US, representing a significant commercial opportunity."
About BRACELET-1
The BRACELET-1 (BReast cAnCEr with the Oncolytic Reovirus PeLareorEp in CombinaTion with anti-PD-L1 and Paclitaxel) study is an open-label, phase 2, randomized study in patients with HR+/HER2-, endocrine-refractory metastatic breast cancer. The study randomized 45 patients 1:1:1 into three cohorts. A three-patient safety run-in was also conducted with patients receiving pelareorep, paclitaxel, and avelumab prior to randomization. The three cohorts are treated as follows:
- Cohort 1: paclitaxel
- Cohort 2: paclitaxel + pelareorep
- Cohort 3: paclitaxel + pelareorep + avelumab (Bavencio®)
Patients in cohort 1 receive paclitaxel on days 1, 8, and 15 of a 28-day cycle. Patients in cohort 2 receive the same paclitaxel regimen as cohort 1, plus pelareorep on days 1, 2, 8, 9, 15 and 16 of the 28-day cycle. Patients in cohort 3 receive the same combination and dosing regimen as cohort 2, plus avelumab on days 3 and 17 of the 28-day cycle. The primary endpoint of the study is overall response rate at week 16. Exploratory endpoints include progression-free survival, peripheral and tumor T cell clonality, inflammatory markers, and safety and tolerability assessments. Additional data from BRACELET-1 and information on the breast cancer program can be found by clicking here.
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.
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 confidence in our plan to conduct a registration-enabling study to assess pelareorep-based combination therapy in patients with advanced HR+/HER2- breast cancer; the potential market and commercial opportunities for pelareorep; our belief that pelareorep is poised to advance 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. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such 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:
Jon Patton
Director of IR & Communication
jpatton@oncolytics.ca
Investor Relations for Oncolytics:
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
tim@lifesciadvisors.com
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FAQ
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