Oncolytics Biotech Inc.
FDA fast track designation received for the treatment of pancreatic cancer
TSX: ONC | CAD 2.36 | Outperform | Speculative Risk | Price Target CAD 6.00
Sentiment: Positive
Our view: ONC announced that FDA has granted fast track designation to pelareorep (pela) for the treatment of advanced/ metastatic pancreatic cancer. We view this news as incrementally positive for the stock. At the KOL webinar on pancreatic cancer last month (here), the company had noted that it would discuss the strong results generated thus far in the Ph1/2 GOBLET study with the regulators to advance the company's pancreatic cancer program into a pivotal trial. At the last earnings call, management had noted that it plans to pursue a single licensing deal for both the breast cancer and pancreatic cancer programs.
Fast track designation for pancreatic cancer treatment. FDA granted fast track designation to pela in combination with Roche's anti-PD-L1 checkpoint inhibitor atezolizumab, and the chemotherapeutic agents gemcitabine and nab-paclitaxel, for the treatment of advanced/metastatic pancreatic ductal adenocarcinoma (PDAC). This is pela's second FDA fast track designation. Management noted the fast track designation will provide ONC with the opportunity for more frequent communication with FDA and that should aid on the best design for a registrational PDAC study. Additionally, clinical programs with fast track designation may be eligible for accelerated approval and priority review, if relevant criteria are met.
Strong Ph1/2 GOBLET clinical data presented at SITC 2022 annual meeting. Patients in the cohort were treated with the combination of pela, Roche's anti-PD-L1 checkpoint inhibitor atezolizumab (TECENTRIQ), and the chemotherapeutic agents gemcitabine and nab-paclitaxel. The data showed one complete response (CR), eight partial responses (PR), two stable disease (SD) and two progressive disease (PD) achieved in thirteen evaluable patients. The 69% objective response rate (ORR) was nearly three times greater than the average ORR of ~25% reported in historical control trials. Management has noted that the robust efficacy signal in GOBLET study markedly exceeded internal expectations and is especially encouraging given most responding patients had their tumor regressions confirmed by subsequent evaluations with one PR deepening into a confirmed CR as of the latest data cut (12-Oct-22).
Tumor response at Weeks 8, 16 and 24: Of the 13 evaluable patients at Week 8, 6 patients had PR, 5 had SD, and 2 had PD. Of the 9 evaluable patients at Week 16, 1 had CR, 7 had PR, and 1 had SD. Of the 6 evaluable patients at Week 24, 1 had CR, 3 had PR, and 2 had PD.