FDA Grants FTD to Pelareorep Plus Atezolizumab and Chemotherapy for Advanced PDAC

The FDA has granted fast track designation to the combination of pelareorep (Reolysin) and atezolizumab (Tecentriq) with gemcitabine and nab-paclitaxel, for the treatment of patients with advanced or metastatic pancreatic ductal adenocarcinoma (PDAC). This is the second fast track designation granted to pelareorep.¹

The FDA action regarding the pelareorep combination comes on the heels of data from the phase 1/2 GOBLET study (Eudra-CT: 2020-003996-16), which were presented during the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting. Results showed that pelareorep plus atezolizumab with gemcitabine and nab-paclitaxel achieved an objective response rate (ORR) of 69%.

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

GOBLET, multiple-indication biomarker study, is exploring the safety and efficacy of pelareorep administered in combination with atezolizumab, gemcitabine, and nab-paclitaxel in patients with gastrointestinal tumors, including pancreatic cancer, colorectal cancer, and anal cancer. For these diseases, chemotherapy remains the standard of care option. Although immunotherapy is available to combine with chemotherapy for the treatment of these patients, the efficacy is limited to a small subgroup. GOBLET investigators hypothesized that use of the pelareorep may decrease tumor size.^1–3

Overall, 13 patients with advanced/metastatic PDAC have been evaluated in GOBLET. Of the 69% of patients who achieved an objective response, 1 had a complete response, 8 achieved partial responses, and 2 had stable disease. The pelareorep combination showed a high rate of objective response compared with the historical control of gemcitabine plus nab-paclitaxel at 25%.

The most frequent adverse events (AEs) were pyrexia (61%), thrombocytopenia (39%), and chills (6%). None of the common AEs were high grade, Common grade 3/4 events observed during the study included neutropenia (17%), and neutrophil count decrease (11%). Overall, pelareorep plus atezolizumab, gemcitabine, and nab-paclitaxel was well-tolerated in patients with advanced or metastatic PDAC.⁴

"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,” said Coffey, in the press release.

_REFEERENCES:

_{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 2, 2022. https://bit.ly/3XSpKRe}

_{2. Oncolytics Biotech® presents updated clinical data at SITC Annual Meeting showing a 69% objective response rate and confirmed complete response in GOBLET study's pancreatic cancer cohort. News release. Oncolytics Biotech. November 10, 2022. Accessed December 2, 2022. https://bit.ly/3EYnKOq}

_{3. Colienne M, Loghmani H, Heineman TC, et al. GOBLET: a phase I/II study of pelareorep and atezolizumab +/- chemo in advanced or metastatic gastrointestinal cancers.Future Oncol. 2022;18(26):2871-2878.doi: 10.2217/fon-2022-0453}

_{4. Arnold D, Collienne M, Stein A, et al. Pelareorep combined with atezolizumab and chemotherapy demonstrates encouraging results as first-line treatment in advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) patients – Interim results from the GOBLET study. Presented at: SITC 37th Annual Meeting; November 8–12, 2022; Abstract 650.}