GenVec believes the data may allow the company to implement modifications to the study that could potentially accelerate its conclusion and allow an earlier review by the FDA than previously anticipated.
The analysis of overall survival data, based on available results in the study showed a 42.5% absolute increase in overall survival with the addition of TNFerade to standard of care (SOC). At one year, survival was 70.5% in the TNFerade + SOC arm, versus 28% in the SOC arm. Significance was at the 75% confidence interval level, and was based on 5 deaths out of 33 TNFerade patients and seven deaths out of 18 SOC patients.
TNFerade is a DNA carrier, which contains the gene for TNF-alpha, an immune system protein with potent and well-documented anticancer effects, for direct injection into tumors. After administration, TNFerade stimulates the production of TNF-alpha in the tumor.
GenVec is developing TNFerade for use in combination with radiation and chemotherapy for the treatment of various cancers.