After receiving approvals in brain cancer and mesothelioma for its tumor-treating electric fields, Novocure has secured a breakthrough designation from the FDA for the company’s devices aimed at aggressive liver cancer.
Following final results in July from a phase 2 pilot study, Novocure hopes to move its therapy into an additional phase 2 trial as a first-line option for unresectable or metastatic tumors when given in combination with Tecentriq (atezolizumab) and Avastin (bevacizumab).
Worn as a patch over the skin, the electric fields disrupt the division and reproduction of cancer cells of a specific size, while minimizing their effects on healthy cells.
“Our data suggest that [Tumor Treating Fields] have the potential to extend survival in this particularly aggressive disease,” Novocure CEO Asaf Danziger said in a statement. “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 company’s completed phase 2 pilot study of liver cancer patients combined its devices with sorafenib. Among the 11 patients who completed 12 weeks of treatment, 10 showed disease control, while two participants saw their tumors shrink.
Novocure is also assessing the therapy in non-small cell lung cancer. This past April, the company received a green light from the FDA to move forward with a phase 2 clinical trial pairing the electric fields with Keytruda (pembrolizumab) in the first-line setting. The study has at least five sites actively enrolling participants.
Also in April, a phase 3 trial in late-stage lung cancer—comparing the devices' use with docetaxel to their use with immune checkpoint inhibitors—received the FDA’s blessing to continue with about half as many participants as previously planned. The decision was based on the trial’s recruitment rate and an interim analysis showing no evidence of increased side effects. Novocure said it expects final, 12-month follow-up data in 2022.