NEW YORK – Viracta Therapeutics said on Monday that based on recent discussions with the US Food and Drug Administration, the company will launch a global registrational trial for nanatinostat and valganciclovir for the treatment of patients with relapsed or refractory Epstein-Barr virus (EBV)-positive lymphoma in the first half of 2021.
The company held a meeting last month with the FDA to discuss planned chemistry, manufacturing, and control topics. Based on the outcome of the meeting, Viracta decided to advance a registrational trial next year that will be able to support multiple marketing approvals in different EBV-positive lymphoma subtypes.
"Alignment with the FDA on our registrational trial design and manufacturing plans provide clarity about our development pathway to potential marketing approval for our combination product candidate," Viracta CEO and President Ivor Royston said in a statement.
Last week, Viracta and Sunesis Pharmaceuticals announced the two companies would merge in an all-stock transaction and focus on advancing Viracta's precision oncology pipeline of products against virus-associated cancers, including nanatinostat for the treatment of Epstein-Barr virus (EBV)-positive relapsed and refractory lymphomas.
At the American Society of Hematology's annual meeting this week, researchers presented data from a Phase II study of nanatinostat-valganciclovir in relapsed or refractory EBV-positive lymphoma patients who had failed one or more prior therapies and were out treatment options. As of the Oct. 27 cutoff date, 46 patients with B-cell non-Hodgkin lymphoma, T cell or NK cell NHL, immunodeficiency-associated lymphoproliferative disorder, and Hodgkin lymphoma were enrolled.
Researchers reported complete responses across several EBV-positive lymphoma subtypes. Notably, the overall response rate was 80 percent in T cell or NK cell NHL, and 66 percent in diffuse large B-cell lymphoma. The regimen was generally well tolerated.