Novocure today announced final results from its phase 2 pilot HEPANOVA trial in liver cancer testing the safety and efficacy of Tumor Treating Fields (TTFields) together with sorafenib for the treatment of advanced hepatocellular cancer. In 21 evaluable patients, the disease control rate was 76% in a patient population with poor prognosis and limited exposure to study treatments. The objective response rate for the intent-to-treat population was 9.5%. In patients who completed at least 12 weeks of TTFields treatment, the disease control rate was 91% with an objective response rate of 18%. The final HEPANOVA results will be presented at the virtual ESMO World Congress on Gastrointestinal Cancer on July 1.
The HEPANOVA trial enrolled 27 patients with unresectable hepatocellular cancer. Fourteen of the 27 patients, or 52%, had a Child-Turcotte-Pugh (CTP) score of 7 or 8, representing significant liver dysfunction. Six patients, or 22% of the study population, survived less than 12 weeks. The median sorafenib treatment duration was only nine weeks, a much shorter treatment duration than the referenced historical controls1. The median treatment duration of TTFields was 10 weeks.
“We are very encouraged by the HEPANOVA results, especially in light of the poor prognosis of the study population and low treatment exposure,” said Dr. Uri Weinberg, Novocure’s Chief Science Officer. “We intend to initiate a randomized controlled trial as soon as possible and are working with key opinion leaders to finalize a protocol incorporating the evolving treatment landscape in advanced liver cancer. We are particularly interested in the potential to use TTFields together with immunotherapy in this aggressive disease given in vivo data which suggest that using TTFields together with anti-PD-1 therapy results in increased tumor response versus either therapy alone.”
The objective response rate reached 9.5% in the 21 evaluable patients, more than double the historical controls. The disease control rate was 76%, a much higher rate than the historical controls of 43% to 52%. For the 11 patients who completed at least 12 weeks of TTFields therapy, the objective response rate was 18%. The disease control rate for patients who completed at least 12 weeks of TTFields therapy was 91%. The objective response rate is defined as the percentage of patients who achieved complete or partial response. The disease control rate includes the percentage of responders plus the patients who achieved stable disease. In the intent-to-treat population, median progression free survival was 5.8 months and median time-to-progression was 8.9 months, higher than the historical, sorafenib alone control for both endpoints. No increase in the toxicity of sorafenib and no device-related serious adverse events were reported.
“Hepatocellular cancer is a particularly aggressive disease,” said Professor Anca-Ligia Grosu, Medical Director at the University of Freiburg, and the principal investigator of the HEPANOVA trial. “A clear unmet need remains for safe and effective combination treatments. These data show that Tumor Treating Fields have the potential to extend survival in advanced liver cancer without increasing side effects. I look forward to further exploration of efficacy in a randomized, controlled trial.”
1 Llovet JM, et al. N Engl J Med. 2008;359:378–390. Abou-Alfa GK, et al. J Clin Oncol. 2006;24(26):4293-4300. Zhu AX, et al. J Clin Oncol. 2015;33(6):559-566. Cainap C, et al. J Clin Oncol. 2015;33(2):172-179.