The FDA and Oncternal Therapeutics Inc (NASDAQ: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.
