Novocure has received the CE mark for Optune Pax, its portable medical device intended to treat adults with locally advanced pancreatic cancer of exocrine origin.
The device is intended to be used in combination with gemcitabine and nab-paclitaxel, as recommended by clinical guidelines.
The decision was based on findings from the Phase III PANOVA-3 clinical trial.
In the study, patients treated with Optune Pax along with gemcitabine and nab-paclitaxel demonstrated a statistically significant improvement in median overall survival compared to those treated with chemotherapy alone.
The trial also showed a significant extension in the time to pain progression, which was identified as a key secondary endpoint.
It enrolled 571 patients with locally advanced pancreatic cancer.
Patients were randomised to receive either the combination of Optune Pax with gemcitabine and nab-paclitaxel or chemotherapy alone, with at least 18 months of follow-up.
In the intent-to-treat group, median overall survival reached 16.2 months for those receiving the device and chemotherapy, compared to 14.2 months for chemotherapy alone.
For the modified intent-to-treat group, which included those who received at least 28 days of device therapy or a full chemotherapy cycle, median survival rose to 18.3 months in the device group versus 15.1 months for chemotherapy only.
One-year survival rates were higher in groups treated with Optune Pax, with 68.1% in the intent-to-treat population and 75.2% in the modified group, compared to 60.2% and 65.9%, respectively, in those who did not receive the device.
The median time to pain progression, an important consideration in pancreatic cancer care, extended to 15.2 months for the device group versus 9.1 months for those on chemotherapy only.
No significant difference was observed in progression-free survival, response rate, local tumour progression or resectability between the two treatment arms. Safety findings indicated that Optune Pax was generally well-tolerated.
The primary device-related side effects were skin reactions, mainly mild to moderate. Fatigue was the most common non-skin adverse event. No device-related deaths or unanticipated safety issues were recorded during the study.
Novocure EMEA and Canada senior vice-president Anne Calixte de Lembeye said: “The CE Mark designation is a critical milestone in our efforts to bring Optune Pax to people living with locally advanced pancreatic cancer, a disease in need of new treatment options.
“We are proud of this achievement and are committed to working with national agencies to secure access to Optune Pax for patients with pancreatic cancer who may benefit from treatment.”
In November 2024, Novocure gained clearance from the US Food and Drug Administration for new head flexible electrode transducer arrays for use with Optune Gio, a wearable for treating adults with glioblastoma, a form of brain cancer.
