Viracta Therapeutics Announces Preliminary Dose-Ranging Data from the Phase 1b/2 Trial of Nana-val in Advanced Epstein-Barr Virus-Positive (EBV+) Solid Tumors at the ESMO Immuno-Oncology Congress
Data from first two dose levels of Nana-val in patients with EBV+ recurrent/metastatic nasopharyngeal carcinoma support continued dose escalation to determine the optimal recommended Phase 2 dose
Excerpt from the Press Release:
SAN DIEGO, Nov. 30, 2022 (GLOBE NEWSWIRE) — Viracta Therapeutics, Inc. (Nasdaq: VIRX), a precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide, today reported preliminary dose-ranging data from the first two dose levels of the dose escalation part of the Phase 1b/2 study of Nana-val in patients with EBV+ recurrent/metastatic nasopharyngeal carcinoma (R/M NPC). The data are featured in an abstract accepted for a poster presentation at the European Society for Medical Oncology Immuno-Oncology Congress (ESMO-IO), which is taking place both virtually and in-person at the Palexpo Exhibition Centre in Geneva, Switzerland, from December 7 – 9, 2022.
The Phase 1b/2 trial’s first two dose levels enrolled seven patients with EBV+ R/M NPC, six of whom were evaluable for response as of the abstract’s data cut-off date (September 15, 2022). At the time of enrollment, patients had received a median of two prior systemic therapies. All patients were refractory to their last therapy with bone (6/7), liver (5/7), and lung (3/7) metastases.
Key data reported in the abstract include:
- Nana-val was well tolerated with no dose limiting toxicities (DLTs) reported. Most common Grade 1-2 AEs were fatigue, nausea, and increased creatinine (n=3 each).
- Two of six evaluable patients achieved stable disease (SD) per RECIST v1.1 criteria.
- Plasma EBV DNA titers decreased or remained stable in both patients achieving SD, while rising in patients with progressive disease.
“We initiated this study earlier this year, and this abstract reports the first preliminary data on our all-oral combination regimen in patients with advanced Epstein-Barr virus-positive NPC, where few treatment options are available,” said Lisa Rojkjaer, M.D., Chief Medical Officer of Viracta.
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