Monday, Viracta Therapeutics Inc VIRX reported topline results from Stage 1 of the pivotal Phase 2 NAVAL-1 trial from both arms of the relapsed or refractory (R/R) Epstein-Barr virus-positive (EBV+) peripheral T-cell lymphoma (PTCL) cohort.
Patients were randomized to either nanatinostat monotherapy (n=10) or nanatinostat in combination with valganciclovir (Nana-val, n=10).
Nana-val (nanatinostat in combination with valganciclovir) demonstrated greater efficacy than nanatinostat monotherapy and was generally well-tolerated. The median duration of response continues to mature.
Efficacy was evaluated as of the February 7, 2024 data cutoff date.
- In the Nana-val arm, the overall response rate (ORR) was 50%, and the complete response rate (CRR) was 20% in the intent-to-treat (ITT) population (N=10); the ORR was 71%, and the CRR was 29% in the efficacy-evaluable population (N=7).
In the nanatinostat monotherapy arm, the ORR and CRR were 10% and 0%, respectively, in the ITT population (N=10), and the ORR was 13% in the efficacy-evaluable population (N=8).
- Five nanatinostat monotherapy patients crossed over to receive Nana-val, two of whom remain on Nana-val treatment with stable disease as of the data cutoff.
Safety was also evaluated as of the February 7, 2024 data cutoff date.
The most common treatment-related adverse events in both treatment arms were thrombocytopenia, anemia, fatigue, decreased appetite, nausea, diarrhea, and weight loss.
These adverse events were primarily mild to moderate in severity and generally manageable or reversible.
Price Action: VIRX shares are down 15.7% at $0.97 on the last check Monday.
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