Drugs / REOLYSIN®
last change 12 days ago re-read 8 days ago

REOLYSIN®

Other / unclassified

Developed for
plasma cell myeloma · breast cancer · pancreatic adenocarcinoma · colorectal cancer · pancreatic ductal adenocarcinoma · anal squamous cell carcinoma · breast carcinoma · Ewing sarcoma/peripheral primitive neuroectodermal tumor
+20 more · fallopian tube carcinoma · female breast carcinoma · fibrosarcoma · head and neck squamous cell carcinoma · infiltrating bladder urothelial carcinoma · leiomyosarcoma · malignant glioma · melanoma · metastatic melanoma · non-small cell lung carcinoma · osteosarcoma · ovarian carcinoma · pancreatic acinar cell carcinoma · primary peritoneal carcinoma · skin cancer · squamous cell lung carcinoma · synovial sarcoma · triple-negative breast carcinoma · undifferentiated pleomorphic sarcoma · prostate cancer
Investigated by
Oncolytics Biotech · National Cancer Institute (NCI) · University of Texas · University of Leeds · AIO-Studien-gGmbH · Adlai Nortye Biopharma Co., Ltd.
+19 more · Bristol-Myers Squibb · Canadian Cancer Trials Group · Celgene Corporation · City of Hope Medical Center · Crolll Gmbh · Emory University · Incyte Corporation · Montefiore Medical Center · Mridula George, MD · Myeloma UK · NRG Oncology · National Institutes of Health (NIH) · Northwestern University · Phylogeny · PrECOG, LLC. · SOLTI Breast Cancer Research Group · University of Southern California · University of Utah · Yorkshire Cancer Research

Trials 25

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT04102618 Mar 2019 → Apr 2022 breast cancer Oncolytics Biotech Terminated No outcome recorded Stop: Enrollment
Phase 18 trials
Phase 1 NCT05519059 Oct 2021 → Sep 2022 breast cancer Adlai Nortye Biopharma Co., Ltd. Completed No outcome recorded
Phase 1 NCT03605719 Oct 2018 → Oct 2022 plasma cell myeloma Emory University Completed No outcome recorded
Phase 1 NCT03015922 Jun 2017 → Sep 2021 plasma cell myeloma University of Leeds Unknown No outcome recorded
Phase 1 NCT02723838 Feb → Sep 2017 infiltrating bladder urothelial carcinoma Oncolytics Biotech Withdrawn No outcome recorded
Phase 1 NCT02620423 Dec 2015 → Mar 2018 pancreatic adenocarcinoma Oncolytics Biotech Completed No outcome recorded
Phase 1 NCT02101944 Dec 2014 → May 2021 anemia, plasma cell myeloma National Cancer Institute (NCI) Completed No outcome recorded
Phase 1 NCT01274624 Dec 2010 → Feb 2018 colorectal cancer Oncolytics Biotech Completed No outcome recorded
Phase 1 NCT00528684 Jul 2006 → Apr 2010 malignant glioma Oncolytics Biotech Completed No outcome recorded
Phase 1/23 trials
Phase 1/2 NCT05514990 Oct 2022 → Dec 2026 expected plasma cell myeloma University of Southern California Active not recruiting No outcome recorded
Phase 1/2 NCT07280377 Oct 2021 → Jul 2027 expected anal squamous cell carcinoma, pancreatic ductal adenocarcinoma Oncolytics Biotech Active not recruiting No outcome recorded
Phase 1/2 NCT03282188 Oct 2017 → Jul 2018 melanoma, skin cancer University of Leeds Withdrawn No outcome recorded
Phase 213 trials · 3 met primary · 1 missed
Phase 2 NCT07446322 Apr 2026 → Aug 2027 expected colorectal cancer Oncolytics Biotech Recruiting No outcome recorded
Phase 2 NCT04445844 Jul 2020 → Jun 2025 overdue female breast carcinoma, triple-negative breast carcinoma Mridula George, MD Active not recruiting No outcome recorded
Phase 2 NCT04215146 Jun 2020 → Aug 2022 overdue breast carcinoma Oncolytics Biotech Active not recruiting No outcome recorded
Phase 2 NCT03723915 Nov 2018 → Dec 2019 pancreatic adenocarcinoma Northwestern University Terminated No outcome recorded Stop: Enrollment
Phase 2 NCT01656538 Feb 2013 → Nov 2016 breast cancer Canadian Cancer Trials Group Completed No outcome recorded
Phase 2 NCT01199263 Dec 2010 → Jun 2015 fallopian tube carcinoma, ovarian carcinoma, primary peritoneal carcinoma National Cancer Institute (NCI) Completed No outcome recorded
Phase 2 NCT01280058 Dec 2010 → Jan 2016 pancreatic acinar cell carcinoma, pancreatic ductal adenocarcinoma National Cancer Institute (NCI) Completed Missed primary
Phase 2 NCT00998192 Oct 2009 → Sep 2013 squamous cell lung carcinoma Oncolytics Biotech Completed Met primary
Phase 2 NCT00998322 Oct 2009 → Dec 2013 pancreatic adenocarcinoma Oncolytics Biotech Completed Met primary
Phase 2 NCT00984464 Sep 2009 → Feb 2014 metastatic melanoma Oncolytics Biotech Completed No outcome recorded
Comparator or background therapy4 trials
Phase 2 NCT01619813 Comparator Dec 2012 → Apr 2016 prostate cancer Canadian Cancer Trials Group Completed No outcome recorded
Phase 2 NCT01708993 Comparator Dec 2012 → Jan 2016 non-small cell lung carcinoma Canadian Cancer Trials Group Completed No outcome recorded
Phase 2 NCT01622543 Comparator Oct 2012 → Jan 2017 colorectal cancer Canadian Cancer Trials Group Completed No outcome recorded
Phase 3 NCT01166542 Comparator Jun 2010 → Apr 2012 head and neck squamous cell carcinoma Oncolytics Biotech Completed No outcome recorded

News releases announcing trial results or a regulatory action · 211

DateIssuerRelease
2026-09-29 Oncolytics Biotech Results Oncolytics Biotech® Announces Publication Demonstrating Pelareorep Creates Immune Responses in Liver Cancer That Make Tumors Susceptible to Immunotherapy oncolyticsbiotech.com ↗
2026-09-10 Oncolytics Biotech Results Oncolytics Biotech® Announces Positive Preclinical Results Combining Pelareorep with a Pan-RAS Inhibitor in Colorectal Cancer oncolyticsbiotech.com ↗
Oncolytics Biotech ® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced positive preclinical results evaluating pelareorep in combination with a pan-RAS inhibitor in a RAS-driven colorectal cancer model.
2026-07-20 Oncolytics Biotech Regulatory Oncolytics Biotech® Receives Fast Track Designation for Pelareorep in Second-Line and Later Anal Cancer oncolyticsbiotech.com ↗
2026-06-01 Oncolytics Biotech Results Oncolytics Biotech® Announces Positive Initial Preclinical Findings Supporting Further Evaluation of Pelareorep in Combination with RAS-Targeted Approaches oncolyticsbiotech.com ↗
Oncolytics Biotech ® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage company developing pelareorep, today announced initial data from a preclinical study evaluating pelareorep in combination with RAS inhibitor modalities in a solid tumor model, which demonstrate evidence of greater anti-tumor activity in combination than with the individual approaches alone.
2026-05-22 Oncolytics Biotech Results Oncolytics Biotech® to Present Data at ASCO 2026 Reinforcing Pelareorep’s Potential Across Gastrointestinal Tumors oncolyticsbiotech.com ↗
The combination of pelareorep, letrozole, and atezolizumab resulted in 60% of patients experiencing 30% or greater increases in their CelTIL score.
2026-05-04 Oncolytics Biotech Results Oncolytics Biotech® Reports Durable Responses in Second-Line RAS-Mutant MSS Colorectal Cancer oncolyticsbiotech.com ↗
Pelareorep-based combination therapy demonstrated a 19.5-month median duration of response in second-line (“2L”) KRAS-mutant MSS mCRC patients in the REO 022 study, compared to historical benchmarks of approximately 4–6 months in this setting.
2026-03-19 Oncolytics Biotech Results Oncolytics Biotech® to Present New Mechanistic and Translational Data Supporting Pelareorep as an Immune-Priming Backbone at AACR 2026 oncolyticsbiotech.com ↗
The combination of pelareorep, letrozole, and atezolizumab resulted in 60% of patients experiencing 30% or greater increases in their CelTIL score.
2026-02-04 Oncolytics Biotech Regulatory Oncolytics Biotech® Receives FDA Fast Track Designation for Pelareorep in 2L KRAS-Mutant MSS Metastatic Colorectal Cancer oncolyticsbiotech.com ↗
As part of the Company’s increased focus on gastrointestinal cancer and analysis of the existing colorectal data set in the fall, the Company applied for and has now received Fast Track Designation.
2026-01-12 Oncolytics Biotech Results Oncolytics Biotech® Announces Updated Clinical Data from GOBLET Cohort 4 Demonstrating Activity of Pelareorep Plus Atezolizumab in Third-Line Anal Cancer oncolyticsbiotech.com ↗
As of the current data cut, four of 14 evaluable third-line patients receiving pelareorep and atezolizumab achieved objective responses, resulting in an objective response rate (“ORR”) of approximately 29%.
2025-12-16 Oncolytics Biotech Results Oncolytics Biotech® Announces Promising Efficacy and Translational Data Supporting Pelareorep in KRAS-Mutant Metastatic Colorectal Cancer oncolyticsbiotech.com ↗
In that same study, patients receiving the pelareorep, bevacizumab, and FOLFIRI treatment regimen more than doubled progression-free survival and overall survival compared to those receiving bevacizumab and FOLFIRI ( click here for the PR ).
2025-11-19 Oncolytics Biotech Regulatory Oncolytics Biotech® Aligns with FDA on Pivotal Study Design for Pelareorep in First-Line Pancreatic Cancer oncolyticsbiotech.com ↗
The FDA’s feedback confirms that our design is appropriate to support registration if successful.
2025-10-28 Oncolytics Biotech Results Oncolytics Biotech® Reports Updated Anal Cancer Data Showing Objective Response Rate More Than Double the Current Standard of Care oncolyticsbiotech.com ↗
The combination of pelareorep and atezolizumab achieved an objective response rate (ORR) of 30% (six among 20 evaluable patients).

All press releases naming this drug 281 releases

DateIssuerRelease
Show all 281 releases opens the full record — a long page

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 29 sources stand behind the page.

FieldValueCited text
Known as REOLYSIN ClinicalTrials.gov intervention name — accepted as the source's own label NCT00998322 ↗
15

NCT00984464 ↗

NCT00503295 ↗

NCT03282188 ↗

NCT01622543 ↗

NCT01274624 ↗

NCT00861627 ↗

NCT00528684 ↗

NCT01619813 ↗

NCT02723838 ↗

NCT00998192 ↗

Show 5 more sources

Known as Pelareorep “OBJECTIVES: Pelareorep (reolysin), a Dearing strain of reovirus serotype 3, has demonstrated oncolytic activity as single agent and synergy with chemotherapy.” PMID 29748010 ↗ Mar 2018
12

“Randomized Phase 2 Trial of the Oncolytic Virus Pelareorep (Reolysin) in Upfront Treatment of Metastatic Pancreatic Adenocarcinoma.” PMID 27039845 ↗ Apr 2016

“Patients also receive Pelareorep IV over 60 minutes on days 1, 2, 3, and 8 in course 1 and on days 1 and 8 of subsequent courses.” NCT03723915 ↗

NCT04102618 ↗

NCT04445844 ↗

NCT07446322 ↗

NCT07280377 ↗

NCT02101944 ↗

NCT04215146 ↗

NCT03605719 ↗

NCT05519059 ↗

Show 2 more sources

Known as Previously REOLYSIN “Previously REOLYSIN®” NCT04102618 ↗
Known as Reovirus Serotype 3 - Dearing Strain “Reovirus Serotype 3 - Dearing Strain (REOLYSIN®) is a naturally occurring, ubiquitous, non-enveloped human reovirus.” NCT02723838 ↗
Known as Reovirus Type 3 Dearing “A Phase 2 Study of Intravenous Administration of REOLYSIN (Reovirus Type 3 Dearing) in Combination With Paclitaxel and Carboplatin in Patients With Metastatic Melanoma” NCT00984464 ↗
1

“REOLYSIN® (Reovirus Type 3 Dearing)” NCT00998192 ↗

Modality Other / unclassified “unmodified oncolytic reovirus” NCT00503295 ↗
Route Intravenous “given intravenously” NCT00503295 ↗