FDA Grants New Tumor Treating Fields System Breakthrough Device Designation in Metastatic Liver Cancer

The FDA has granted a breakthrough device designation to the NovoTTF-200T System, a tumor treating fields (TTFields) delivery system, for the treatment of unresectable or metastatic liver cancer, according to a press release by Novocure.¹

NovoTTF-200T is meant to be used in combination with atezolizumab (Tecentriq) and bevacizumab (Avastin) for first-line treatment. TTFields disrupt cancer cell division through electric fields. They are meant to be used in combination with other standard-of-care treatments.

“We are very pleased that the FDA has granted breakthrough designation for Tumor Treating Fields together with atezolizumab and bevacizumab to treat advanced liver cancer,” said Asaf Danziger, CEO of Novocure, 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.”

The approval is based on the phase 2 HEPANOVA trial (NCT03606590), which had an actual enrollment of 75 participants. It had the primary end points of overall response rate (ORR) up to 30 months. Secondary end points include in-filed control rate, overall survival, progression-free survival (PFS), distant metastases-free survival, and the severity and frequency of adverse events.² 

During the study, patients were continuously treated with TTFields in combination with sorafenib (Nexavar). Of the 27 patients, 52% had a Child-Turcotte-Pugh (CPT) score of 7 or 8. Twenty-two percent of the population survived less than 12 weeks. The median treatment duration with sorafenib was 9 weeks and 10 weeks with TTFields.³

Twenty-one patients were evaluated. The disease control rate was 76%. The ORR was 9.5%. For patients who completed at least 12 weeks of treatment with TTFields, the disease control rate was 91% and the ORR was 18%. In the overall population, the median PFS was 5.8 months and the median time to progression was 8.9 months, which is higher than historical sorafenib alone data.

No increase in sorafenib toxicity was reported. Additionally, NovoTTF-200T had no serious AEs associated with it.

“We are very encouraged by the HEPANOVA results, especially in light of the poor prognosis of the study population and low treatment exposure,” said Uri Weinberg, MD, PhD, chief science officer of Novocure, in a press release. “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.”

_REFERENCES:

_{FDA grants breakthrough device designation to the NovoTTF-200T™ system for advanced liver cancer. News release. Novocure. September 9, 2021. Accessed September 10, 2021. https://bit.ly/3A2vJ9I} 

_{Effect of tumor treating fields (TTFields, 150kHz) concomitant with sorafenib for advanced hepatocellular carcinoma (HCC) (HEPANOVA). ClinicalTrials.gov. Accessed September 10, 2021. https://bit.ly/3laNJIO}

_{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/3hkOw8U}