FDA Approves Tumor Treating Fields Device for Pancreatic Cancer Treatment

The FDA has approved Optune Pax, a wearable medical device that delivers Tumor Treating Fields (TTFields), for the treatment of adult patients with locally advanced pancreatic cancer (LA-PAC) alongside gemcitabine and nab-paclitaxel. This decision marks the first new treatment approach approved for the locally advanced pancreatic cancer population in approximately 30 years. The approval was supported by results from PANOVA-3, a global, randomized, open-label, pivotal phase 3 clinical trial.

In the intention-to-treat population, treatment with Optune Pax and chemotherapy resulted in a statistically significant improvement in median overall survival, reaching 16.2 months compared with 14.2 months for patients receiving chemotherapy alone. The 1-year survival rate in the ITT population was also significantly improved at 68.1% in the Optune Pax arm versus 60.2% in the control arm. In the modified per protocol population, the median overall survival benefit was more pronounced at 18.3 months compared with 15.1 months.

The trial also demonstrated significant benefits in secondary and post hoc end points. Median time to pain progression was extended by 6.1 months, reaching 15.2 months with the device compared to 9.1 months with chemotherapy alone. Additionally, distant progression-free survival was significantly improved at 13.9 months vs 11.5 months. No significant differences were observed in secondary measures of objective response rate, local PFS, or resectability rates.

The addition of Optune Pax did not exacerbate the systemic toxicities typically associated with gemcitabine and nab-paclitaxel. Serious adverse events were comparable between study arms. Device-related adverse events were largely localized skin reactions beneath the wearable arrays, occurring in 76.3% of treated patients. The majority of these skin events were mild to moderate; however, 7.7% of patients experienced a grade 3 or worse skin event. Non-skin device-related adverse events included fatigue, reported by 5.1% of participants.

Optune Pax is recommended at a daily usage of at least 75% (approximately 18 hours per day). In the PANOVA-3 trial, the median daily device usage was 62.1%. Contraindications for Optune Pax include the presence of active electrical implants, known sensitivity to medical hydrogels, and pregnancy.

TTFields are non-invasive, alternating electric fields that target the unique electrical properties of cancer cells to disrupt processes needed for cell division and survival. By exerting physical forces on cancer cells, TTFields cause cell death while generally sparing healthy cells, which have different electrical and morphological properties.

The study enrolled 571 patients with newly diagnosed, unresectable LA-PAC and randomized them 1:1 to receive either gemcitabine and nab-paclitaxel alone or the chemotherapy combination with Optune Pax. The primary end point of the trial was overall survival.