Optune Pax Is Approved in Japan for Unresectable Locally Advanced Pancreatic Cancer

Japan’s Ministry of Health, Labour and Welfare has approved Optune Pax for concomitant use with gemcitabine and nab-paclitaxel (Abraxane) in adult patients with unresectable, locally advanced pancreatic cancer, according to a news release from Novocure. The wearable device delivers Tumor Treating Fields (TTFields), alternating electric fields designed to disrupt processes involved in cancer cell division.

The approval was supported by data from the phase 3 PANOVA-3 trial (NCT03377491), which compared the tumor-treating fields (TTFields) device plus gemcitabine and nab-paclitaxel vs chemotherapy alone in the first-line setting. In the intention-to-treat population, the median overall survival (OS)—the trial’s primary end point— was 16.2 months with TTFields plus chemotherapy (95% CI, 15.0-18.0) vs 14.2 months (95% CI, 12.8-15.4) with chemotherapy alone (HR, 0.82; 95% CI, 0.68-0.99; P = .039).² The 1-year OS rates were 68.1% and 60.2%, respectively (P = .029).

“The approval of Optune Pax provides a promising new treatment option for locally advanced pancreatic cancer, a disease with an urgent need for effective therapies,” Makoto Ueno, MD, PhD, director of the Department of Gastroenterology at Kanagawa Cancer Center in Yokohama, Japan, stated in a news release.¹ “In the Phase 3 PANOVA-3 trial for Optune Pax, there was a statistically significant improvement in overall survival and pain progression was delayed, helping to preserve overall quality of life for people with this disease.”

The Japan approval follows the February 2026 FDA approval of Optune Pax for concomitant use with gemcitabine and nab-paclitaxel for the treatment of adult patients with locally advanced pancreatic cancer.³

How was PANOVA-3 designed?

PANOVA-3 was an international, randomized, open-label phase 3 trial involving 571 patients with newly diagnosed, unresectable locally advanced pancreatic adenocarcinoma.² A life expectancy of at least 3 months and an ECOG performance status of 0 to 2 were required for enrollment.

Patients were randomly assigned 1:1 to receive TTFields with gemcitabine and nab-paclitaxel (n = 285) or gemcitabine and nab-paclitaxel alone (n = 286). TTFields were delivered to the abdomen through arrays worn on the torso, with recommended average device use of at least 18 hours per day.

Along with the primary end point of OS, progression-free survival (PFS), local PFS, 1-year OS rate, pain-free survival, overall response rate, and safety served as secondary end points.

What additional efficacy data supported the approval?

Median pain-free survival was 15.2 months with TTFields plus chemotherapy vs 9.1 months with chemotherapy alone (HR, 0.74; 95% CI, 0.56-0.97; P = .027). A post hoc analysis also found longer median distant PFS at 13.9 months vs 11.5 months, respectively (HR, 0.74; 95% CI, 0.57-0.96; P = .022).

Median overall PFS was 10.6 months in the TTFields group vs 9.3 months in the chemotherapy-alone group, a difference that was not statistically significant (HR, 0.85; 95% CI, 0.68-1.05; P = .137). Among patients evaluable for response, the ORRs were 36.1% and 30.0%, respectively (P = .094).

What was the safety profile?

According to Novocure, adding Optune Pax did not worsen the systemic toxicity associated with gemcitabine and nab-paclitaxel, and serious adverse effects (AEs) were comparable between groups. Device-related skin AEs beneath the arrays occurred in 76.3% of patients who received TTFields. Most of these AEs were grade 1 or 2, although 7.7% experienced a grade 3 or higher skin AE. No new safety signals were identified in the trial.

References

1. Novocure. Novocure’s Optune Pax receives approval in Japan for the treatment of unresectable locally advanced pancreatic cancer. News release. October 1, 2026. Accessed October 1, 2026. https://www.businesswire.com/news/home/20261001277516/en/Novocures-Optune-Pax-Receives-Approval-in-Japan-for-the-Treatment-of-Unresectable-Locally-Advanced-Pancreatic-Cancer
2. Babiker HM, Picozzi V, Chandana SR, et al. Tumor Treating Fields with gemcitabine and nab-paclitaxel for locally advanced pancreatic adenocarcinoma: randomized, open-label, pivotal phase III PANOVA-3 study. J Clin Oncol. 2025;43(21):2350-2360. doi:10.1200/JCO-25-00746
3. FDA approves first-of-its-kind device to treat pancreatic cancer. FDA. February 12, 2026. Accessed October 1, 2026. https://www.fda.gov/news-events/press-announcements/fda-approves-first-its-kind-device-treat-pancreatic-cancer