Oncternal Therapeutics Inc. (NASDAQ: ONCT) has announced that after a successful End-of-Phase 2 meeting with the US FDA for zilovertamab, its experimental anti-ROR1 monoclonal antibody. In addition, key features of the company’s possibly pivotal third phase clinical study of zilovertamab for the treating of refractory or relapsed mantle cell lymphoma patients were agreed upon by the FDA and the company.
FDA has agreed in study design
The FDA has also examined and agreed on the essential design aspects and operational components of the company’s third phase clinical study protocols and Statistical Analysis Plan, which are currently being finalized with FDA input.
Oncternal’s President and CEO “James Breitmeyer said, The completion of End-of-Phase 2 meetings and consensus on clinical trial design and other program elements mark a meaningful and encouraging milestone for Oncternal Therapeutics. The agreement underscores our productive dialogue with the FDA on key elements of our program and the Phase 3 clinical trial design as we align on the potential path to commercialization for zilovertamab, which offers potential advantages to patients suffering from aggressive lymphomas such as MCL. The positive data from our ongoing Phase 1/2 CIRLL study recently presented at ASH 2021 underscore those advantages and are supportive of our registration strategy.”
The third phase superiority clinical study ZILO-301 is entitled, “Randomized, Double-blind, Placebo-controlled, Multi-center Phase 3 Study of Zilovertamab (A ROR1 Antibody) Plus Ibrutinib Versus Ibrutinib Plus Placebo in Patients with Relapsed or Refractory Mantle Cell Lymphoma.”
Patients of r/r MCL experienced stable disease
Patients with refractory or relapsed MCL that have experienced a partial response or stable disease after 4 months of oral ibrutinib treatment will be randomly assigned to receive blinded zilovertamab or placebo, with all patients continuing to receive oral ibrutinib. The primary endpoint will be progression-free survival, which will be used to support the filing of a Biologics License Application (BLA) to the FDA for regular approval. The overall response rate (ORR) and duration of response will be the primary outcome of an interim analysis that could support filing a BLA seeking fast FDA clearance.
