This section highlights FDA-related milestones and regulatory updates for drugs developed by Oncolytics Biotech (ONCY).
Over the past two years, Oncolytics Biotech has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
atezolizumab and Pelareorep. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
atezolizumab (Tecentriq) - FDA Regulatory Timeline and Events
atezolizumab (Tecentriq) is a drug developed by Oncolytics Biotech for the following indication: Early-stage breast cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- atezolizumab (Tecentriq)
- Announced Date:
- October 8, 2024
- Indication:
- Early-stage breast cancer
Announcement
Oncocyte Corp. announced the peer-reviewed publication of positive data related to its proprietary gene expression test, DetermaIO™.
AI Summary
Oncocyte Corp. announced that new, positive data on its proprietary gene expression test, DetermaIO™, has been peer-reviewed and published in Clinical Cancer Research. This study, part of the NeoTRIP clinical trial for triple-negative breast cancer, shows that DetermaIO effectively predicts which patients are likely to benefit from combining immunotherapy with chemotherapy. Patients with a positive DetermaIO result had a significantly higher complete tumor response rate when treated with atezolizumab plus chemotherapy compared to those receiving chemotherapy alone.
The findings highlight that DetermaIO outperforms other biomarkers, making it a useful tool for selecting patients for immune checkpoint inhibitors. These promising results support Oncocyte’s efforts to seek CMS reimbursement and expand access to this valuable diagnostic test in precision oncology.
Read Announcement- Drug:
- atezolizumab (Tecentriq)
- Announced Date:
- June 20, 2024
- Indication:
- Early-stage breast cancer
Announcement
Oncolytics Biotech® Inc. announced the dosing of the first patient in the new GOBLET study cohort evaluating pelareorep and modified FOLFIRINOX (mFOLFIRINOX) with or without atezolizumab (Tecentriq®) in newly diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC) patients.
AI Summary
Oncolytics Biotech® Inc. has begun dosing the first patient in a new GOBLET study cohort that evaluates a combination therapy for newly diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC) patients. This study focuses on using pelareorep in combination with modified FOLFIRINOX (mFOLFIRINOX) with or without atezolizumab (Tecentriq®). The trial’s co-primary endpoints are to assess the objective response rate and safety of these regimens, which could potentially enhance treatment outcomes for pancreatic cancer patients.
The study, part of the Phase 1/2 GOBLET multiple indication trial conducted across Germany, is supported by a US$5 million Therapeutic Accelerator Award from PanCAN. Researchers hope the combination of these therapies not only improves tumor response rates but may also provide a new treatment pathway in the battle against this aggressive form of cancer.
Read Announcement- Drug:
- atezolizumab (Tecentriq)
- Announced Date:
- May 9, 2024
- Estimated Event Date Range:
- April 1, 2024 - June 30, 2024
- Target Action Date:
- Q2 - 2024
- Indication:
- Early-stage breast cancer
Announcement
Oncolytics Biotech® announced that First patient expected to be enrolled in Q2 2024
AI Summary
Oncolytics Biotech® has announced an important milestone in its clinical development plan with the first patient expected to be enrolled in its upcoming trial in Q2 2024. This enrollment marks a significant step forward in the company’s efforts to advance its novel treatment options under FDA oversight. The upcoming trial is designed to evaluate the safety and effectiveness of the new approach, and the projected start in Q2 2024 brings fresh optimism for both patients and investors. The planned enrollment demonstrates Oncolytics’ commitment to following rigorous FDA standards while exploring innovative therapies that aim to improve patient outcomes. This move is seen as a pivotal moment in the company’s journey to bring new, potentially life-changing treatments to the market, reinforcing its resolve and strategic planning in clinical research and development.
Read Announcement- Drug:
- atezolizumab (Tecentriq)
- Announced Date:
- May 9, 2024
- Indication:
- Early-stage breast cancer
Announcement
Oncolytics Biotech announced will commence enrollment into a new GOBLET study pancreatic cancer cohort following both German regulatory and ethics approvals.
AI Summary
Oncolytics Biotech has announced that it will soon begin enrolling patients into its new GOBLET study pancreatic cancer cohort. This milestone comes after the company received both German regulatory approval and clearance from ethics committees. The study aims to investigate innovative therapies in a patient group with pancreatic cancer, marking a significant step forward in the fight against this challenging disease.
The approval from German authorities confirms that the study meets the strict standards required for clinical research, ensuring patient safety and ethical compliance. With the enrollment now set to commence, Oncolytics Biotech is poised to enhance our understanding of pancreatic cancer treatment options. The GOBLET study could lead to important breakthroughs by offering new insights and potential therapies for patients who currently face limited treatment alternatives.
Read Announcement
Pelareorep - FDA Regulatory Timeline and Events
Pelareorep is a drug developed by Oncolytics Biotech for the following indication: In Breast Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Pelareorep
- Announced Date:
- July 8, 2025
- Indication:
- In Breast Cancer
Announcement
Oncolytics Biotech® Inc announced a strategic update highlighting its compelling clinical data from two tumor types and outlining a sharpened focus on advancing pelareorep, the Company's intravenously delivered oncolytic virus immunotherapy, into registration-enabling studies.
AI Summary
Oncolytics Biotech® Inc. announced a strategic update that focuses on advancing its pelareorep immunotherapy into registration-enabling studies. The company highlighted strong clinical data from two different types of tumors, including metastatic pancreatic cancer and HR+/HER2- metastatic breast cancer. In recent trials for pancreatic cancer, pelareorep combined with chemotherapy showed a significant survival benefit, with a two-year overall survival rate of 21.9% compared to the historical benchmark of 9.2%. Data from studies in breast cancer also indicated improved survival compared to standard chemotherapy. With these promising results and a well-understood safety profile, the company is moving past early proof-of-concept trials. Oncolytics plans to use its fast-track status to identify an efficient regulatory path this summer and pave the way for future registration-enabling trials, marking an important step in its commitment to bringing new therapy options to patients.
Read Announcement- Drug:
- Pelareorep
- Announced Date:
- May 23, 2025
- Indication:
- In Breast Cancer
Announcement
Oncolytics Biotech® Inc. announced new data from the Phase I/II GOBLET clinical trial in a poster presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.
AI Summary
Oncolytics Biotech® Inc. has shared encouraging new data from its Phase I/II GOBLET clinical trial at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The company presented a poster explaining how its immunotherapeutic agent, pelareorep, works in pancreatic ductal adenocarcinoma (PDAC). The data show pelareorep starts a cascade of immune responses by expanding anti-reovirus T cells, which then improve the immune activity in the tumor microenvironment. This treatment appears to boost the release of cytokines and chemokines, allowing pre-existing tumor-infiltrating lymphocytes (TILs) in the blood to re-enter the tumor and contribute to tumor shrinkage. By mapping these immune responses, the study enhances understanding of how pelareorep can turn “cold” tumors “hot,” potentially improving combination therapies for PDAC patients.
Read Announcement- Drug:
- Pelareorep
- Announced Date:
- April 24, 2025
- Indication:
- In Breast Cancer
Announcement
Oncolytics Biotech® Inc. announced that it will present new data from Cohort 1 of the GOBLET study at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago May 30-June 3, 2025 demonstrating pelareorep's anti-tumor activity in pancreatic ductal adenocarcinoma (PDAC) - the most common form of pancreatic cancer characterized by its poor prognosis and limited treatment options.
AI Summary
Oncolytics Biotech® Inc. will present exciting new data at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago (May 30 – June 3, 2025). The company will showcase findings from Cohort 1 of the GOBLET study, which highlights the anti-tumor activity of its immunotherapy drug pelareorep in pancreatic ductal adenocarcinoma (PDAC). PDAC is the most common form of pancreatic cancer and is known for its poor prognosis and limited treatment options. The study shows that pelareorep can activate the immune system to target pancreatic cancer tumors, a promising step for patients battling this aggressive disease. These results support the potential of pelareorep in combination therapies and mark an important advancement toward more effective treatment strategies in one of the deadliest cancers.
Read Announcement- Drug:
- Pelareorep
- Announced Date:
- February 19, 2025
- Indication:
- In Breast Cancer
Announcement
Oncolytics is pleased to highlight two significant developments for its immunotherapy, pelareorep: the safety and regulatory clearance to advance enrollment in its pancreatic cancer study and the recent presentation of new efficacy and safety data at the 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium in late January.
AI Summary
Oncolytics has announced two key developments for its immunotherapy agent, pelareorep. The company received safety and regulatory clearance to advance enrollment in its pancreatic cancer study. This progress allows the GOBLET Cohort 5 trial to move toward full enrollment, enrolling 30 patients in the first stage while testing pelareorep in combination with modified FOLFIRINOX, both with and without the immune checkpoint inhibitor, atezolizumab.
In addition, the company presented new efficacy and safety data at the 2025 ASCO Gastrointestinal Cancers Symposium held in late January. The data highlighted pelareorep’s promising performance in gastrointestinal cancers, reinforcing its potential to significantly impact treatment options for difficult-to-treat tumors. These developments mark an important step forward in advancing pelareorep’s clinical potential.
Read Announcement- Drug:
- Pelareorep
- Announced Date:
- February 18, 2025
- Indication:
- In Breast Cancer
Announcement
Oncolytics is pleased to highlight two significant developments for its immunotherapy, pelareorep: the safety and regulatory clearance to advance enrollment in its pancreatic cancer study and the recent presentation of new efficacy and safety data at the 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium in late January.
AI Summary
Oncolytics Biotech Inc. announced two important milestones for its immunotherapy, pelareorep. The company received regulatory clearance and confirmed the treatment’s safety, allowing them to advance patient enrollment in their pancreatic cancer study. This development marks a significant step as the trial moves toward full enrollment, aiming to determine pelareorep’s potential when combined with modified FOLFIRINOX, with and without the checkpoint inhibitor atezolizumab.
Additionally, Oncolytics presented new efficacy and safety data at the 2025 ASCO Gastrointestinal Cancers Symposium held in late January. The data highlighted promising results in challenging gastrointestinal cancers, demonstrating pelareorep’s potential to effectively target hard-to-treat tumors. These advancements support the ongoing development of pelareorep as a versatile immunotherapy, reinforcing its role in modern cancer treatment strategies.
Read Announcement- Drug:
- Pelareorep
- Announced Date:
- January 22, 2025
- Indication:
- In Breast Cancer
Announcement
Oncolytics Biotech® Inc today provided details from the abstracts featuring pelareorep that are being presented at the 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium in San Francisco January 23-25, 2025.
AI Summary
Oncolytics Biotech® Inc. today shared details from abstracts on pelareorep that are set for presentation at the 2025 American Society of Clinical Oncology Gastrointestinal Cancers Symposium in San Francisco, January 23-25, 2025. The abstracts highlight new findings on pelareorep-based combination therapies in gastrointestinal cancers.
The data from one abstract show that pelareorep, when combined with checkpoint inhibitors like atezolizumab, continues to demonstrate significant potential in treating relapsed anal cancer. Notably, patients experienced a higher response rate than what is typically seen with checkpoint inhibitor monotherapy, including a case with a complete response lasting over 15 months. Another abstract provides updated safety results for pelareorep used with a modified FOLFIRINOX regimen in pancreatic cancer patients, expanding its potential use. These findings emphasize the ongoing promise of pelareorep in combination treatments for gastrointestinal cancers.
Read Announcement- Drug:
- Pelareorep
- Announced Date:
- January 15, 2025
- Indication:
- In Breast Cancer
Announcement
Oncolytics Biotech® Inc. announced that Germany's medical regulatory body, the Paul-Ehrlich-Institute (PEI), has approved the continuation of patient enrollment into Cohort 5 of the GOBLET study.
AI Summary
Oncolytics Biotech® Inc. announced that Germany’s Paul-Ehrlich-Institute (PEI) has approved the continuation of patient enrollment into Cohort 5 of the GOBLET study. This cohort is evaluating pelareorep in combination with modified FOLFIRINOX (mFOLFIRINOX) with or without atezolizumab (Tecentriq®) in newly diagnosed pancreatic ductal adenocarcinoma patients. An independent Data Safety Monitoring Board reviewed the safety data and recommended the continuation, allowing the study to proceed towards full enrollment of 30 patients in Stage 1.
The study aims to expand treatment options for pancreatic cancer patients by testing pelareorep with a different chemotherapy regimen. Early safety data will be shared at the upcoming 2025 American Society of Clinical Oncology Gastrointestinal Cancers Symposium, with initial efficacy results expected later in the year. This milestone supports ongoing research into innovative therapies to improve patient outcomes in a disease with limited treatment options.
Read Announcement- Drug:
- Pelareorep
- Announced Date:
- December 18, 2024
- Indication:
- In Breast Cancer
Announcement
Oncolytics Biotech® Inc announced the presentation of two data sets through two abstracts showcasing pelareorep's potential in difficult-to-treat gastrointestinal cancers were accepted and will be presented at the 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium in San Francisco January 23-25, 2025.
AI Summary
Oncolytics Biotech® Inc. announced that two sets of study data will be presented at the 2025 American Society of Clinical Oncology Gastrointestinal Cancers Symposium in San Francisco from January 23-25, 2025. The abstracts focus on pelareorep, an immunotherapy agent, and its potential to treat difficult-to-manage gastrointestinal cancers, including pancreatic and anal cancer.
One abstract highlights early safety and tumor responses in relapsed anal carcinoma patients treated with a combination of pelareorep and the checkpoint inhibitor atezolizumab. The other abstract shares results from a safety run-in study of pelareorep combined with modified FOLFIRINOX, with or without atezolizumab, for metastatic pancreatic cancer patients. These presentations underscore pelareorep’s promise in enhancing the effects of chemotherapy and immunotherapy, potentially delaying disease progression and improving patient survival.
Read Announcement- Drug:
- Pelareorep
- Announced Date:
- September 19, 2024
- Indication:
- In Breast Cancer
Announcement
Oncolytics Biotech® Inc. announced positive clinical results from BRACELET-1, its randomized Phase 2 study evaluating pelareorep in patients with HR+/HER2- advanced or metastatic breast cancer.
AI Summary
Oncolytics Biotech® Inc. announced positive final results from its randomized Phase 2 BRACELET-1 study, which evaluated pelareorep combined with paclitaxel in patients with HR+/HER2- advanced or metastatic breast cancer. The study showed that more than half of the patients receiving the combination therapy were still alive at the end, with the median overall survival (OS) not reached. It is estimated that the OS could be at least 32 months compared to 18 months for patients treated with paclitaxel alone.
The trial also demonstrated a significant benefit in progression-free survival, with the combination arm showing an improvement of almost 6 months over chemotherapy alone. These encouraging results support the potential of pelareorep-based combination therapy to extend survival in these patients. Oncolytics is now moving forward to secure funding for a registration-enabling study based on these positive findings.
Read Announcement- Drug:
- Pelareorep
- Announced Date:
- June 27, 2024
- Estimated Event Date Range:
- July 1, 2024 - December 31, 2024
- Target Action Date:
- 2024-H2
- Indication:
- In Breast Cancer
Announcement
Oncolytics Biotech® Inc. announced that On track to report overall survival results from the randomized HR+/HER2- metastatic breast cancer BRACELET-1 trial in H2 2024
AI Summary
Oncolytics Biotech announced that it is on track to report overall survival results from the randomized BRACELET-1 trial in HR+/HER2- metastatic breast cancer during the second half of 2024. This trial is key in evaluating the potential of pelareorep, an immunotherapeutic treatment, to improve survival outcomes in patients who have not responded to hormonal therapy and have had limited exposure to antibody-drug conjugate (ADC) therapy. The upcoming overall survival data is expected to add strength to the evidence supporting pelareorep’s clinical benefits. These results will play an important role in the Company’s efforts to develop a registration-enabling trial and further demonstrate the drug’s impact on improving treatment options for breast cancer patients. The announcement highlights a significant step forward in advancing pelareorep towards registration in this challenging patient population.
Read Announcement- Drug:
- Pelareorep
- Announced Date:
- June 27, 2024
- Indication:
- In Breast Cancer
Announcement
Oncolytics Biotech® Inc. announced that the Company received productive feedback from its Type C meeting with the U.S. Food and Drug Administration (FDA), supporting the planned potential registration-enabling trial for pelareorep in HR+/HER2- metastatic breast cancer (mBC).
AI Summary
Oncolytics Biotech Inc. announced that it received positive feedback from a recent Type C meeting with the U.S. FDA regarding its planned trial for pelareorep in HR+/HER2- metastatic breast cancer (mBC). The FDA agreed with the company’s design, supporting progression‐free survival as the primary endpoint and overall survival as a key secondary endpoint for the study.
The trial is intended for patients who have not responded to hormonal therapy and have had no more than one line of antibody–drug conjugate therapy. This productive meeting feedback represents an essential regulatory milestone, providing a clear path forward toward a registration-enabling trial for pelareorep. The company believes this step helps build on promising clinical evidence and supports its mission to offer better treatment options to mBC patients with high unmet needs.
Read Announcement- Drug:
- Pelareorep
- Announced Date:
- May 24, 2024
- Indication:
- In Breast Cancer
Announcement
Oncolytics Biotech® Inc presented two abstracts at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. One is a trial-in-progress abstract discussing cohort 5 of the GOBLET study, which will evaluate the combination of pelareorep and modified FOLFIRINOX (mFOLFIRINOX) with and without atezolizumab in newly diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC) patients.
AI Summary
Oncolytics Biotech® Inc. presented two abstracts at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. One key abstract describes a trial-in-progress for cohort 5 of the GOBLET study. This study will assess the safety and efficacy of combining pelareorep with modified FOLFIRINOX (mFOLFIRINOX), both with and without the immunotherapy drug atezolizumab, in newly diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC) patients. Researchers will enroll 15 evaluable patients per treatment arm in a Simon two-stage design, with the co-primary endpoints being the objective response rate and safety. If early results are promising, the study will expand to include additional patients. The trial aims to build on previous findings that suggest pelareorep-based therapy might improve outcomes for metastatic PDAC patients, potentially broadening treatment options in this tough-to-treat cancer. Enrollment is expected to begin soon.
Read Announcement- Drug:
- Pelareorep
- Announced Date:
- May 15, 2024
- Indication:
- In Breast Cancer
Announcement
Oncolytics Biotech® Inc. announced that it has entered into a preliminary collaboration with the Global Coalition for Adaptive Research (GCAR).
AI Summary
Oncolytics Biotech® Inc. recently announced a preliminary collaboration with the Global Coalition for Adaptive Research (GCAR). This collaboration is aimed at combining expertise to advance adaptive cancer therapies. By joining forces with GCAR—a group known for its dynamic approach to research—the company hopes to streamline the development of new treatment methods that could improve patient outcomes. This move shows Oncolytics’ commitment to innovative research and its desire to work with global leaders in adaptive techniques.
The partnership is expected to encourage the sharing of scientific insights and resources, which can accelerate the journey from laboratory research to practical, clinical applications. This collaboration marks a promising step toward enhancing treatment strategies and could lead to faster advancements in personalized medicine for cancer patients.
Read Announcement- Drug:
- Pelareorep
- Announced Date:
- April 11, 2024
- Indication:
- In Breast Cancer
Announcement
Oncolytics Biotech® Inc. announce the submission of a Type C meeting request to the FDA.
AI Summary
On April 11, 2024, Oncolytics Biotech® Inc. announced that it submitted a Type C meeting request to the FDA. The company is looking to secure a meeting in Q2 2024 to discuss plans for a registration-enabling trial. This upcoming trial will evaluate pelareorep used in combination with paclitaxel for patients with HR+/HER2- metastatic breast cancer. The discussion aims to finalize the design and objectives of the trial, which is a key step in moving towards FDA registration and making this potential treatment available for patients.
Oncolytics is encouraged by earlier results from studies showing promising outcomes. With overall survival data from the BRACELET-1 trial expected in the second half of 2024, the company believes this meeting will help advance the development of pelareorep as an innovative immunotherapy solution for breast cancer.
Read Announcement
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