Novocure Secures CE Mark for Optune Pax in Locally Advanced Pancreatic Cancer
Novocure has achieved a significant regulatory milestone after receiving the CE (Conformité Européenne) Mark for Optune Pax®, authorizing the device for the treatment of adult patients with locally advanced pancreatic cancer of exocrine origin when used alongside gemcitabine and nab-paclitaxel (gem/nab-pac) in accordance with applicable treatment guidelines. The approval expands the company’s Tumor Treating Fields (TTFields) technology into one of the most difficult-to-treat cancers and represents an important step toward providing new therapeutic options for patients across Europe.
The CE Mark follows positive findings from the international Phase 3 PANOVA-3 clinical trial, which demonstrated that combining Optune Pax with standard chemotherapy significantly improved overall survival compared with chemotherapy alone. The study also showed meaningful improvements in delaying pain progression, a major concern for patients living with advanced pancreatic cancer.
Expanding Treatment Options for a Difficult Disease
Pancreatic cancer remains one of the world’s deadliest malignancies, largely because it is often diagnosed after the disease has progressed beyond the point where surgery is possible. Many patients present with locally advanced pancreatic cancer, where tumors have spread into nearby blood vessels or surrounding tissues, making surgical removal extremely challenging.
Although chemotherapy has improved outcomes over recent decades, survival rates remain relatively low, creating an urgent need for innovative treatment approaches that can work alongside existing standards of care.
Medical experts involved in the PANOVA-3 study believe the CE Mark represents meaningful progress for patients facing limited therapeutic choices.
According to Dr. Teresa Macarulla, Head of the Department of Medical Oncology at Hospital Clínic Barcelona, pancreatic cancer is frequently detected at advanced stages, limiting the effectiveness of current therapies. She noted that the PANOVA-3 trial demonstrated a statistically significant improvement in overall survival among patients receiving Optune Pax in combination with chemotherapy.
She also emphasized that the treatment delayed pain progression, an important outcome because pain is one of the most debilitating symptoms associated with advanced pancreatic cancer. The findings suggest that Optune Pax could provide an important new treatment option for patients who urgently need additional therapies.
How Optune Pax Works
Unlike conventional cancer treatments that rely on drugs or radiation, Optune Pax uses Tumor Treating Fields (TTFields) technology.
TTFields are low-intensity, alternating electric fields delivered directly to the tumor through adhesive arrays worn externally on the patient’s body. The portable device continuously generates these electric fields, which interfere with key biological processes required for cancer cells to divide and multiply.
Because rapidly dividing cancer cells are particularly vulnerable to these electrical disruptions, TTFields can trigger cancer cell death while largely sparing healthy tissues, reducing the risk of many systemic side effects commonly associated with chemotherapy.
Patients wear lightweight arrays connected to a portable generator, allowing treatment to continue during normal daily activities.
CE Mark Based on Positive PANOVA-3 Trial Results
The European approval is supported by results from the Phase 3 PANOVA-3 trial, one of the largest clinical studies evaluating TTFields therapy in pancreatic cancer.
The randomized, prospective, open-label, controlled international study enrolled 571 patients with locally advanced pancreatic cancer who had not previously received treatment for their disease.
Participants were randomly assigned in a 1:1 ratio to receive either:
- Optune Pax together with gemcitabine and nab-paclitaxel, or
- Gemcitabine and nab-paclitaxel alone.
All patients were monitored for at least 18 months, allowing researchers to evaluate both survival outcomes and quality-of-life measures.
The study successfully achieved its primary objective by demonstrating that patients treated with Optune Pax plus chemotherapy experienced statistically significant improvements in median overall survival.
Improved Overall Survival
Among the intent-to-treat (ITT) population, which included all randomized participants, patients receiving Optune Pax alongside chemotherapy achieved a median overall survival of 16.2 months, compared with 14.2 months for those receiving chemotherapy alone.
This represented a statistically significant improvement of 2.0 months, with a hazard ratio of 0.82 and a p-value of 0.039, indicating a meaningful reduction in the risk of death.
Researchers also evaluated outcomes within the modified intent-to-treat (mITT) population. This group included patients who completed at least 28 days of Optune Pax therapy or at least one full chemotherapy cycle.
Results were even more encouraging in this analysis.
Patients receiving Optune Pax plus chemotherapy achieved a median overall survival of 18.3 months, compared with 15.1 months for patients treated with chemotherapy alone.
The 3.2-month improvement was statistically significant, with a hazard ratio of 0.77 and a p-value of 0.023.
These findings indicate that patients able to receive sustained TTFields therapy alongside chemotherapy experienced even greater clinical benefit.
Higher One-Year Survival Rates
In addition to extending median survival, Optune Pax improved one-year survival outcomes.
Within the intent-to-treat population:
- 68.1% of patients receiving Optune Pax plus chemotherapy remained alive after one year.
- 60.2% of patients receiving chemotherapy alone survived for one year.
The modified intent-to-treat analysis showed an even larger benefit:
- 75.2% one-year survival among patients receiving Optune Pax.
- 65.9% one-year survival in the chemotherapy-only group.
These results demonstrate that more patients receiving TTFields therapy survived beyond the critical first year following diagnosis.
Significant Delay in Pain Progression
Pain management remains one of the greatest challenges in pancreatic cancer care.
As tumors enlarge, they frequently compress nerves and surrounding tissues, causing severe and persistent pain that can significantly affect daily functioning and quality of life.
The PANOVA-3 trial therefore included time to pain progression as a key secondary endpoint.
Researchers defined pain progression as either:
- a patient-reported increase of at least 20 points on a standardized visual pain scale, or
- death.
The results demonstrated that Optune Pax substantially delayed worsening pain.
Patients receiving Optune Pax together with chemotherapy experienced a median time to pain progression of 15.2 months, compared with 9.1 months among patients receiving chemotherapy alone.
The 6.1-month extension represented a statistically significant improvement, highlighting the potential of TTFields therapy not only to extend survival but also to preserve patient comfort for longer periods.
Quality of Life Benefits
Researchers also evaluated patients’ overall quality of life throughout the study using internationally recognized questionnaires developed by the European Organisation for Research and Treatment of Cancer (EORTC).
Assessments were conducted at baseline and every eight weeks during treatment.
Patients treated with Optune Pax demonstrated longer deterioration-free survival across several important quality-of-life measures, including:
- Overall health status
- Pain control
- Pancreatic cancer-related pain
- Digestive symptoms
- Emotional well-being
- Fatigue and energy levels
These findings suggest that extending survival with Optune Pax did not come at the expense of patients’ daily quality of life and may instead help preserve important aspects of physical and emotional health.
Other Clinical Endpoints
While several important endpoints showed improvement, researchers reported that certain additional measures did not demonstrate statistically significant differences between the two treatment groups.
These included:
- Progression-free survival
- Local progression-free survival
- Objective response rate
- Puncture-free survival
- Tumor resectability rate
Although these outcomes remained similar between treatment arms, the observed improvements in overall survival and delayed pain progression were sufficient for the trial to meet its primary objective.
Favorable Safety Profile
Safety findings from the PANOVA-3 study were generally consistent with previous experience using Tumor Treating Fields technology.
Researchers reported that adding Optune Pax to chemotherapy did not increase systemic toxicity associated with gemcitabine and nab-paclitaxel.
No unexpected safety concerns emerged during the trial, and the rate of serious adverse events remained comparable between patients receiving combination therapy and those receiving chemotherapy alone.
The most common side effects were localized skin reactions beneath the wearable arrays.
Approximately 76.3% of patients using Optune Pax experienced device-related skin adverse events, most of which were mild or moderate (Grade 1 or Grade 2).
Only 7.7% experienced more severe Grade 3 or higher skin reactions.
Outside of skin-related effects, fatigue was the most frequently reported device-associated adverse event, affecting 5.1% of participants.
Investigators reported one Grade 4 event involving decreased neutrophil count that was considered related to the device, although it was classified as non-serious.
Importantly, there were:
- No device-related deaths.
- No unexpected device-related safety signals.
- No evidence that Optune Pax worsened chemotherapy-related side effects.
Company Plans Next Steps
Novocure views the CE Mark as a major step toward making Optune Pax available to eligible patients throughout Europe.
The company stated that it will now work with national healthcare authorities and reimbursement agencies to secure patient access across individual European markets.
Because treatment guidelines and chemotherapy practices differ among countries, the approved CE Mark specifically references the use of gemcitabine and nab-paclitaxel in accordance with local guideline recommendations, allowing flexibility across different healthcare systems.
As Novocure advances commercialization efforts, the company hopes that Optune Pax will become an additional treatment option for patients diagnosed with locally advanced pancreatic cancer, addressing an area where therapeutic innovation has remained limited for many years. The positive Phase 3 evidence supporting both improved survival and delayed pain progression positions the technology as a promising addition to the current standard of care for this aggressive disease.
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