Oncolytics 再发 GOBLET 队列4肛管癌耐久性数据：mDOR约15个月，但系同一队列旧数据的随访更新，无新临床/监管增量

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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
___________________________________
FORM
8-K
___________________________________
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
October 27, 2026
___________________________________
Oncolytics Biotech Inc.
(Exact name of registrant as specified in its charter)
___________________________________
Nevada
(State or other jurisdiction of
incorporation)
001-38512
(Commission File Number)
98-0541667
(IRS Employer Identification No.)
4350 Executive Drive
,
Suite 325
San Diego
,
CA
92121
92121
(Address of principal executive offices)
(Zip Code)
(
403
)
670-7377
(Registrant's telephone number, including area code)
N/A
(Former name or former address, if changed since last report)
___________________________________
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading Symbol(s)
Name of each exchange on which registered
Common stock, par value $0.001 per share
ONCY
The Nasdaq Stock Market LLC
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Exchange Act (§240.12b-2 of this chapter).
Emerging growth company
☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
☐
Item 8.01. Other Events.
On October 27, 2026, Oncolytics Biotech Inc. (the “Company”) issued a press release announcing updated data from Cohort 4 of the GOBLET study, which is evaluating pelareorep and atezolizumab in second-line and later squamous cell anal cancer. The information set forth in this Item 8.01 and in Exhibit 99.1 is furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No.
Description
99.1
Press Release issued by Oncolytics Biotech Inc., dated as of
October
2
7
, 2026
.
104
Cover Page Interactive Data File (embedded within the Inline XBRL document).
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: October 27, 2026
ONCOLYTICS BIOTECH INC.
By:
/s/ Kirk Look
Name:
Kirk Look
Title:
Chief Financial Officer

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EX-99.1
2
oncygc4updateddata.htm
EX-99.1
Document
Oncolytics Biotech
®
Reports Strong Durability and Survival Data in Anal Cancer, Positioning Pelareorep as Potential Backbone Immunotherapy Across HPV-Driven Cancers
GOBLET Cohort 4 demonstrates approximately 15-month median duration of response that exceeds historical results for approved second-line checkpoint inhibitor monotherapy
100% of responding patients survived for longer than one year
FDA Fast Track Designation and recent regulatory guidance support advancement toward registration and potential expansion into HPV-driven head and neck cancer
SAN DIEGO, CA, October 27, 2026 –
Oncolytics Biotech
®
Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced updated data from Cohort 4 of its Phase 1/2 GOBLET study evaluating pelareorep in combination with atezolizumab (Tecentriq
®
) in patients with second-line or later squamous cell anal cancer (“SCAC”).
Although median overall survival has not yet been reached, the median duration of response is approximately 15 months,
1
which compares favorably with historical results of 9.5 months for U.S. Food and Drug Administration (“FDA”)-approved retifanlimab monotherapy in a similar patient population.
2
Notably, all patients who responded to treatment survived beyond 12 months, including multiple patients surviving over 24 months.
These results provide encouraging evidence that pelareorep enhanced the clinical benefit of checkpoint inhibition in advanced SCAC, a disease in which more than 90% of cases are associated with human papillomavirus (“HPV”).
“We see anal cancer as the starting point for building a pelareorep plus checkpoint inhibitor platform across HPV-driven cancers,” said Jared Kelly, Chief Executive Officer of Oncolytics. “Our survival data and recent FDA regulatory clarity give us a path to pursue registration in anal cancer while expanding into other HPV-associated tumors, including head and neck cancer, where pelareorep has already demonstrated encouraging clinical activity.”
FDA Pathway Opens Door to Broader HPV Cancer Platform
Following recent FDA interactions and receipt of Fast Track Designation, Oncolytics plans to explore additional clinical studies with a potential checkpoint inhibitor partner to support registrational development in SCAC. The Company believes that durable clinical responses may support an accelerated approval pathway, while overall survival could provide evidence of clinical benefit supporting full approval, subject to FDA agreement.
The Company also sees potential to expand into HPV-associated head and neck squamous cell carcinoma. HPV accounts for approximately 70% of oropharyngeal cancers in the United States, representing a substantial patient population where checkpoint inhibitors are already established therapies.
Pelareorep has previously demonstrated signals of antitumor activity in head and neck cancer studies, although it has not yet been evaluated in combination with a checkpoint inhibitor in this disease. Oncolytics may explore initiating such a combination study in the near term as part of its broader HPV-driven cancer strategy.
About GOBLET
The GOBLET (
G
astrointestinal tum
O
rs exploring the treatment com
B
inations with the oncolytic reovirus pe
L
ar
E
orep and an
T
i-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 Germany and is being managed by AIO-Studien-gGmbH (“AIO”). The co-primary endpoints of the study are objective response rate and/or disease control rate and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers. The study comprises five treatment groups:
1.
Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in first-line advanced/metastatic pancreatic cancer patients;
2.
Pelareorep in combination with atezolizumab in first-line MSI (microsatellite instability)-high metastatic colorectal cancer patients;
3.
Pelareorep in combination with atezolizumab and TAS-102 in third-line metastatic colorectal cancer patients
4.
Pelareorep in combination with atezolizumab in second-line advanced and unresectable anal cancer patients; and
5.
Pelareorep in combination with mFOLFIRINOX with and without atezolizumab in newly diagnosed metastatic PDAC patients.
About AIO
AIO emerged from the study center of the medical oncology working group within the German Cancer Society. 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 Pelareorep
Pelareorep is an intravenously delivered, systemically active, investigational immunotherapy with a dual mechanism of action that selectively replicates in tumor cells while activating both innate and adaptive anti-tumor immune responses, including the upregulation of key inflammatory cytokines resulting in the formation of tertiary lymphoid structures and the expansion of tumor-infiltrating lymphocytes. It has been administered to over 1,200 patients, and clinical studies have demonstrated pelareorep’s potential to enhance the activity of checkpoint inhibitors and other anti-cancer therapies across multiple solid tumor types.
About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an investigational intravenously delivered double-stranded RNA immunotherapeutic agent. Pelareorep has demonstrated encouraging 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 is designed to induce anti-cancer immune responses by converting immunologically inactive tumors to active through the activation of innate and adaptive immune responses.
The Company is advancing pelareorep in combination with chemotherapy and/or checkpoint inhibitors in metastatic gastrointestinal cancers, where pelareorep has received Fast Track designation from the FDA
for colorectal, anal, and pancreatic cancer. Oncolytics is actively pursuing strategic partnerships to accelerate development and maximize commercial impact. For more about Oncolytics, please visit:
www.oncolyticsbiotech.com or follow the Company on LinkedIn and on X @oncolytics.
Tecentriq
®
(atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.
References
1.
GOBLET Cohort 4 efficacy estimates supplied from internal calculations for this draft
2.
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
Forward-looking statements
This press release contains forward-looking statements, within the meaning of Section 21E of the U.S. 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 beliefs as to the potential, registration, mechanism of action and benefits of pelareorep as a cancer therapeutic; the results, and implication of results, from Cohort 4 of the GOBLET study; the Company’s plans to explore additional clinical studies related to SCAC and its beliefs in their potential benefits; the Company’s possible expansion into HPV-associated head and neck cancer including a study in combination with pelareorep; the Company’s goals, strategies, and objectives; the Company’s belief in the clinical promise of pelareorep in anal, colorectal, pancreatic and other gastrointestinal cancers; and the Company’s goals and expectations for its potential registrational development path for pelareorep in multiple gastrointestinal cancers. 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. These statements involve known and unknown risks and uncertainties that may cause actual results to differ materially from those anticipated. These risks include, but are not limited to, regulatory outcomes, trial execution, financial resources, access to capital markets, and market dynamics. Please refer to Oncolytics’ public filings with securities regulators in the United States and Canada for more information. The Company assumes no obligation to update forward-looking statements, except as required by law.
Company Contact
Jon Patton
Director of IR & Communication
jpatton@oncolytics.com