FDA Grants Fast Track Designation to Pelareorep for Advanced/Metastatic Pancreatic Cancer

Matt Coffey, PhD, MBA

The FDA has granted a fast track designation to pelareorep for use in combination with atezolizumab (Tecentriq), gemcitabine, and nab-paclitaxel (Abraxane) for the treatment of patients with advanced or metastatic pancreatic cancer.¹

This represents pelareorep’s second FDA fast track designation.

“Receiving this fast track designation is an important accomplishment that speaks to the impressive response rate and the durability of the response in our pancreatic ductal adenocarcinoma [PDAC] study, and it also reflects the pressing need to improve upon the standard of care in this indication,” Matt Coffey, PhD, MBA, president and chief executive officer of Oncolytics Biotech Inc, said in a press release.

Pelareorep is a naturally occurring, non-genetically modified reovirus. Administered intravenously, pelareorep selectively kills tumor cells and promotes immunologic effects that prime tumors to respond to checkpoint inhibition.²

Because of its expected synergy with checkpoint inhibition and promising antitumor activity in prior gastrointestinal (GI) cancer studies, the phase 1/2 GOBLET study (EudraCT 2020-001038-36) was designed to evaluate pelareorep plus atezolizumab across several GI cancers.

GOBLET is an open-label, non-randomized, multiple-cohort study in patients with advanced or metastatic GI cancers. The study employs a Simon two-stage design. In stage 1, patients will be enrolled into 1 of 4 cohorts: first-line pancreatic cancer treated with pelareorep plus atezolizumab, gemcitabine and nab-paclitaxel (cohort 1; n = 12); first-line microsatellite instable–high colorectal cancer (CRC) treated with pelareorep plus atezolizumab (cohort 2; n = 19); third-line CRC treated with pelareorep plus atezolizumab and trifluridine/tipiracil (cohort 3; n = 14); and second-line or later squamous cell carcinoma of the anal canal treated with pelareorep plus atezolizumab (cohort 4; n = 10).

The first 3 to 6 patients enrolled into the chemotherapy-containing cohorts (cohorts 1 and 3) will undergo a safety run-in that must be successfully completed before enrolling additional patients into these cohorts.

The primary objectives are safety and efficacy based on objective response rate (ORR) at week 16. Any cohort showing a promising ORR in stage 1, based on pre-specified criteria, may be advanced to stage 2 and enroll additional patients.

In November 2022, at the 2022 SITC Annual Meeting, interim clinical data from the phase 1/2 GOBLET study showed a 69% ORR including complete responses (n = 13) with the quadruplet as frontline therapy in a cohort of patients with advanced or metastatic PDAC.³ Notably, the ORR was nearly triple the average ORR of approximately 25% reported in historical control trials evaluating gemcitabine plus nab-paclitaxel in pancreatic cancer.

“We expect the opportunity for more frequent communication about our data with FDA provided by this designation will be invaluable as we work to align with the Agency on the best design for a registrational PDAC study. With our core programs in breast and pancreatic cancer both nearing pivotal trials, and eligible for the fast track program’s numerous benefits, we believe we are at a crucial point in Oncolytics’ evolution and are excited for what's ahead,” Coffey concluded.

References

1. Oncolytics Biotech^® Receives FDA Fast Track Designation for the Treatment of Advanced/Metastatic Pancreatic Cancer. News release. Oncolytics Biotech. December 1, 2022. Accessed December 1, 2022. https://bit.ly/3VH5FLx
2. Arnold D, Collienne M, Wilkinson GA, et al. GOBLET: A phase 1/2 multiple-indication biomarker, safety, and efficacy study in advanced or metastatic gastrointestinal cancers exploring treatment combinations with pelareorep and atezolizumab. J Clin Oncol. 2022;40(suppl 4):TPS216. doi:10.1200/JCO.2022.40.4_suppl.TPS216
3. Arnold D, Loghmani H, Trauger R, et al. Pelareorep combined with atezolizumab and chemotherapy demonstrates encouraging results as first-line treatment in advanced or metastatic pancreatic cancer. Presented at: 2022 SITC Annual Meeting; November 8-12, 2022; Boston, MA. Abstract 650