Oncternal, FDA In Pact For Pivotal Study Design For Zilovertam In Mantle Cell Lymphoma

The FDA and Oncternal Therapeutics Inc ONCT have agreed on key elements of the Company's Phase 3 trial of zilovertamab for relapsed or refractory mantle cell lymphoma (MCL).

• The FDA has also reviewed and agreed upon the key design features and operational details of Oncternal's Phase 3 trial protocol and Statistical Analysis Plan, which is being finalized based on the FDA's input.
• The study will randomize patients with relapsed or refractory MCL who have experienced stable disease or partial response after receiving four months of oral ibrutinib therapy.
• All patients will continue receiving oral ibrutinib. 
• The primary endpoint will be progression-free survival (PFS). 
• Study ZILO-301, expected to initiate in Q2 of 2022, will be conducted internationally in at least 50 centers.
• The Company is also planning to conduct Study ZILO-302, an open-label companion study of zilovertamab plus ibrutinib for patients with progressive disease during the initial four months of ibrutinib monotherapy from Study ZILO-301.
• The Company shared updated data for zilovertamab in combination with Ibrutinib at ASH 2021.
• The data showed an objective response rate of 81% and a complete response rate of 35% for the combination therapy.
• Price Action: ONCT shares are up 8.12% at $2.53 during the premarket session on the last check Wednesday.