Updated data from the GOBLET trial show pelareorep plus atezolizumab achieved a 29% ORR with durable responses in heavily pretreated SCAC.
Treatment with the combination of pelareorep and atezolizumab (Tecentriq) led to an objective response rate (ORR) of approximately 29% (n = 4) as third-line therapy in 14 evaluable patients with heavily pretreated metastatic squamous cell anal carcinoma (SCAC), according to updated data from cohort 4 of the phase 1/2 GOBLET trial (NCT07280377).1
At the data cutoff, best responses included 2 complete responses and 2 partial responses. The median duration of response was approximately 17 months, which compares favorably with historical third-line data showcasing an ORR of approximately 10% or less, with transient durability.
“As we continue to analyze the GOBLET data, we are finding important trends that are helping to shape our clinical development strategy,” Jared Kelly, chief executive officer of Oncolytics, pelareorep’s developer, stated in a news release. “When you isolate to [patients with] anal cancer with 2 prior lines of treatment and see a strong signal like this, it points the arrow in a direct line to a registration study in an indication where there are no FDA-approved therapies. We already had good data here, but looking closer, it becomes clearer that we can make an immediate impact on patients’ lives who have no options.”
GOBLET is an open-label, phase 1/2 multi-indication trial intended to evaluate the safety, efficacy, and potential biomarkers of response associated with pelareorep and atezolizumab in 5 cohorts of patients with advanced or metastatic gastrointestinal cancers.2 Only cohort 5 will be randomized.
The 5 cohorts are as follows: first-line locally advanced or metastatic, unresectable pancreatic ductal adenocarcinoma (PDAC); first-line metastatic, microsatellite instability–high (MSI-H)/mismatch repair–deficient (dMMR) colorectal cancer (CRC); third-line CRC independent of MSI/dMMR status; second- or later-line locally advanced or metastatic, unresectable SCAC of viral or non-viral origin following chemotherapy; and first-line metastatic PDAC.
Eligible patients must be at least 18 years of age and have an ECOG performance status of 0 or 1, measurable lesions per RECIST 1.1 criteria, and adequate hematologic, renal, and hepatic function. Patients must have also recovered from any adverse effect from prior therapy or surgery to grade 1 or baseline. All patients with childbearing potential must also agree to use contraception during the study and 6 months thereafter.
Within the SCAC cohort, patients are receiving 4.5 x 1010 of 50% of the tissue culture infectious dose (TCID50) of pelareorep via a 1-hour intravenous (IV) infusion, plus an 840 mg IV infusion of atezolizumab.
The primary end points are ORR in cohorts 1, 2, 4, and 5, disease control rate (DCR) in cohort 3, and overall survival (OS) in cohort 5. Secondary end points included progression-free survival, duration of response, DCR, as well as ORR and OS in cohorts 1 through 4.
Previously reported data from the trial indicated that the regimen produced an ORR of 33% in 12 patients, more than doubling the ORR seen with retifanlimab-dlwr (Zynyz) in the pivotal POD1UM-202 trial (NCT03597295).3,4
In September 2025, Oncolytics announced that they had submitted a protocol amendment to allow the study to open at sites in the US.3
Oncolytics is expected to launch a confirmatory, registrational study, which if positive will serve as the basis for potential accelerated approval in this indication.1 The company is also planning to hold a Type C meeting with the FDA in the first quarter of 2026 to review next steps regarding the agent’s development.
