NovoTTF-200T Delivery System Given a Breakthrough Designation by the FDA for Advanced Liver Cancer

The NovoTTF-200T System was given a breakthrough designation by the FDA as treatment strategy that may work in conjunction with bevacizumab and atezolizumab to treat patients with advanced liver cancer.

The FDA has granted a breakthrough designation to the NovoTTF-200T System, which can be used to deliver electrical fields to tumors that are also being treated with systemic bevacizumab (Avastin) and atezolizumab (Tecentriq) in patients with unresectable or metastatic liver cancer in the frontline setting, according to a press release from the system’s developer Novocure.1

The designation was based in part on the results of the pilot phase 2 HEPANOVA trial (NCT03606590), which examined the safety and efficacy of Tumor Treating Fields (TTFields) plus sorafenib (Nexavar) in a population of 21 patients with advanced liver cancer.2 Findings from the trial, which were presented at the 2021 ESMO World Congress on Gastrointestinal Cancer, indicated that patients who underwent treatment experienced a disease control rate (DCR) of 76% despite the population having a poor prognosis and limited exposure to study treatments. The study’s intent-to-treat population had an objective response rate (ORR) of 9.5%. In particular, those who underwent at least 12 weeks of TTFields treatment experienced a DCR of 91%, as well as an ORR of 18%.

By granting the designation, the FDA acknowledges that the delivery system is a breakthrough in the treatment of advanced liver cancer and has the potential to be a more effective treatment for the disease.

“We are very pleased that the FDA has granted breakthrough designation for [TTFields] together with atezolizumab and bevacizumab to treat advanced liver cancer,” Asaf Danziger, chief executive officer at Novocure, said in a press release. “Our data suggest that TTFields have the potential to extend survival in this particularly aggressive disease. We are working closely with trial investigators and intend to initiate a randomized controlled trial studying TTFields in combination with atezolizumab and bevacizumab as soon as possible.”

TTFields are electric fields that interrupt cancer cell division and are intended to be used in conjunction with other standard-of-care therapies. A growing body of data indicate that the technology may have application with other therapies, including radiotherapy, as well as select chemotherapies and immunotherapies.

The HEPANOVA trial enrolled a total of 27 patients, 52% of whom had a Child-Turcotte-Pugh score of 7 or 8, indicating significant liver dysfunction. Twenty-two percent of the population survived less than 12 weeks. The median duration of treatment with sorafenib was 9 weeks and the median duration of treatment with TTFields was 10 weeks.

Additional findings from the trial indicated that the median progression-free survival in the intent-to-treat population was 5.8 months and the median time to progression was 8.9 months. Investigators did not report an increase in toxicity nor did they report any device-related serious adverse effects.

References

  1. FDA grants breakthrough device designation to the NovoTTF-200T™ System for advanced liver cancer. News release. Novocure. September 10, 2021. Accessed September 10, 2021. https://bwnews.pr/2YKk6q9
  2. Novocure Presents Final Safety and Efficacy Results from its Phase 2 Pilot HEPANOVA Trial in Liver Cancer. News release. Novocure. July 1, 2021. Accessed September 10, 2021. https://bit.ly/3hg5ncX