FDA Approves Optune Pax for Locally Advanced Pancreatic Cancer

Novocure reports that the U.S. Food and Drug Administration approved Optune Pax for adult patients with locally advanced pancreatic cancer, to be used concomitantly with gemcitabine and nab-paclitaxel.

The company says the decision was supported by findings from the Phase 3 PANOVA-3 trial and describes the product as a wearable device that delivers Tumor Treating Fields.

The announcement describes PANOVA-3 as an international, prospective, randomized, open-label, controlled Phase 3 trial that enrolled 571 patients, comparing Optune Pax plus gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel alone. The trial met its primary endpoint and presents median overall survival differences between study arms in both populations it cites: in the intent-to-treat population, 16.2 months with Optune Pax plus chemotherapy versus 14.2 months with chemotherapy alone (HR 0.82; 95% CI 0.68–0.99; p=0.039); in the modified per-protocol population, 18.3 months versus 15.1 months, respectively (HR 0.77; 95% CI 0.62–0.97; p=0.023). These overall survival differences are reported as statistically significant in both analyses.

The release also highlights several secondary outcomes and notes others that were not statistically different. It reports higher one-year survival in both the intent-to-treat (68.1% vs 60.2%) and modified per-protocol (75.2% vs 65.9%) populations. For symptoms, it reports a longer median time to pain progression with Optune Pax plus chemotherapy than with chemotherapy alone (15.2 vs 9.1 months) and defines pain progression as a patient-reported increase of 20 or more points on a visual scale for pain or death. Quality of life is described as assessed at baseline and every 8 weeks using the EORTC QLQ-C30 with the pancreatic cancer–specific PAN26 addendum, with longer deterioration-free survival reported for global health status and several symptom domains. There was no significant difference between arms for progression-free survival, local progression-free survival, objective response rate, puncture-free survival, or tumor resectability.

In its “Indication and Important Safety Information” section, the company reports that serious adverse events were comparable between study arms and that no new safety signals were observed. It characterizes Optune Pax as well tolerated and says it did not exacerbate gemcitabine/nab-paclitaxel–related systemic toxicity.

Device-related skin adverse events under the arrays were reported in 76.3% of Optune Pax–treated participants; most were Grade 1–2, and 7.7% were Grade ≥3. The release also notes that fatigue was the most common non–skin device-related adverse event (5.1%), reports one Grade 4 device-related adverse event (a non-serious neutrophil count decrease), and states that no device-related adverse events led to death and no unanticipated device-related safety issues were observed. The release lists contraindications and precautions, including warnings about use in pregnancy (and birth control for women who can become pregnant), considerations for people with certain electrical implants, and sensitivity to gels like those used on ECG stickers or TENS electrodes. It also says Optune Pax should only be used after training by qualified personnel who have completed a Novocure training course. Practical constraints include using only kit-supplied parts, avoiding getting the device or arrays wet, and awareness of tripping risk from a cord plugged into an electrical socket.

Overall, the release’s safety and logistics details describe device-specific considerations in the setting of concurrent systemic therapy for this indication.

Key Takeaways:

• The announcement reports FDA approval for Optune Pax in adults with locally advanced pancreatic cancer, for concomitant use with gemcitabine and nab-paclitaxel.
• PANOVA-3 is described as meeting its primary endpoint, with statistically significant overall survival differences reported in the populations analyzed.
• The release describes systemic adverse effects reported with concomitant chemotherapy and device-related skin adverse events under the arrays, and it lists contraindications/precautions and a training requirement as part of its important safety information.