Viracta Therapeutics announces data from Phase 2 NAVAL-1 trial

Viracta Therapeutics reported positive Phase 2 NAVAL-1 trial results from Stages 1 and 2 of the relapsed or refractory (R/R) Epstein-Barr virus-positive peripheral T-cell lymphoma cohort. Additionally, the Company received productive feedback from its meeting with the U.S. Food and Drug Administration, providing clarity on the potential regulatory path to initial registration of Nana-val in patients with R/R EBV+ PTCL. Based on FDA’s feedback, Viracta plans to begin a randomized controlled trial of Nana-val in the second half of 2025. As of the June 28, 2024 data cutoff, combined Stages 1 and 2 data demonstrated: In the R/R EBV+ PTCL population: The overall response rate was 33% and the complete response rate was 19% in the intent-to-treat population; the ORR was 41% and the CRR was 24% in the efficacy-evaluable population. In the second-line EBV+ PTCL subpopulation: The ORR was 60% and the CRR was 30% in the ITT population; the ORR was 67% and the CRR was 33% in the EE population; Median duration of response has not yet been reached. Nana-val was generally well-tolerated: The most common treatment-related adverse events were fatigue, nausea, decreased appetite, diarrhea, platelet count decreased, and anemia. These adverse events were primarily mild to moderate in severity and generally manageable or reversible. Based on the Company’s meeting with FDA and the particularly robust response rates observed in the second-line treatment setting, Viracta will focus Nana-val’s clinical development on patients with R/R EBV+ PTCL