FDA Approves Optune Pax Device for Locally Advanced Pancreatic Cancer

The Food and Drug Administration (FDA) has approved Optune Pax, a Tumor Treating Fields (TTFields) delivery system, for the treatment of adult patients with locally advanced pancreatic cancer alongside gemcitabine and nab-paclitaxel (gem/nab-pac). The approval marks the first new treatment for locally advanced pancreatic cancer in nearly 30 years.

TTFields emit targeted alternating electric fields to disrupt the electrical processes essential for cancer cell division and survival, thereby selectively inhibiting tumor growth and inducing cell death. Optune Pax is a portable medical device that delivers TTFields non-invasively. The therapy is administered via wearable arrays, which consist of electrically insulated adhesive patches placed on the skin and connected to an electric field generator, which is carried in a specially designed bag.

The approval was based on data from the randomized, open-label phase 3 PANOVA-3 trial (ClinicalTrials.gov Identifier: NCT03377491), which evaluated the safety and efficacy of Optune Pax with gem/nab-pac in 571 adults, 18 years and older with locally advanced pancreatic adenocarcinoma.

Study participants were randomly assigned (1:1) to receive intravenous gemcitabine 1000mg/m2 and nab-paclitaxel 125mg/m2 once daily on days 1, 8, and 15 of a 28-day cycle with or without Optune Pax. The primary endpoint was overall survival (OS).

Findings showed treatment with Optune Pax alongside gem/nab-pac statistically significantly improved OS compared with gem/nab-pac alone (hazard ratio [HR], 0.82 [95% CI, 0.68-0.99]; P =.039). Median OS was 16.2 months (95% CI, 15.0-18.0) in the TTFields regimen arm and 14.2 months (95% CI, 12.8-15.4) in the gem/nab-pac monotherapy arm.

Findings also showed the 1-year survival rate was significantly greater among patients treated with Optune Pax plus gem/nab-pac vs those receiving gem/nab-pac alone (68.1% vs 60.2%; P =.029). Notably, the median time to pain progression was significantly prolonged when Optune Pax was added to gem/nab-pac vs without (15.2 months vs 9.1 months; HR, 0.74 [95% CI, 0.56-0.97]; P =.027).

In the modified per protocol population — defined as patients who received at least 28 days of Optune Pax therapy concomitant with gem/nab-pac arm or at least one complete cycle of gem/nab-pac — patients treated with Optune Pax and gem/nab-pac had a median overall survival of 18.3 months vs 15.1 months with gem/nab-pac alone. A larger proportion of this group (75.2%) also lived for more than one year compared to the chemotherapy-only group (65.9%).

There were no significant differences between treatment groups in other secondary outcomes, such as progression free survival, local progression free survival, objective response rate, puncture free survival or tumor resectability rate.

Optune Pax demonstrated a favorable safety profile and did not increase the systemic toxicity associated with gem/nab-pac. Device-related adverse events were mainly mild to moderate skin reactions and occurred in 76.3% of patients, including 7.7% with grade 3 or higher events.

Patients are trained to use the device, including how to recharge and replace device batteries, connect the device to an external power supply, place the adhesive patches in the appropriate positions on the body, and replace the transducer arrays at least twice per week. The technological parameters are preset by the manufacturer, allowing patients to receive continuous treatment while performing their daily activities.

The cost is roughly $21,000 per month, comparable to many oncology drugs, and covers equipment rental, replacement arrays and supplies, and support services such as help with insurance coverage and adherence monitoring.

The CEO of Novocure stated that systemic therapies have shown poor bioavailability in pancreatic tumors, limiting their effectiveness. Optune Pax is a fundamentally different treatment, utilizing a biophysical approach that targets the unique electrical properties of cancer cells.

Novocure's TTFields system carries previous indications for glioblastoma, metastatic mesothelioma, and metastatic non-small cell lung cancer. Novocure is investigating TTFields in a wide range of additional tumors, including breast, colorectal, renal, and cervical cancer.