On July 1, 2025 Novocure (NASDAQ: NVCR) reported that it will present the final secondary endpoint results from the Phase 3 PANOVA-3 trial of its Tumor Treating Fields (TTFields) therapy for unresectable, locally advanced pancreatic cancer (Press release, NovoCure, JUL 1, 2025, View Source [SID1234654205]). These data from PANOVA-3 were accepted as a late-breaking abstract for oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Gastrointestinal Cancers Congress 2025, taking place July 2 to July 5 in Barcelona, Spain.

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"In the PANOVA-3 trial, there was a significant improvement in overall survival and a significant delay in the progression of pain as well as delayed opioid medication use in patients treated with Tumor Treating Fields and chemotherapy compared to chemotherapy alone. Pancreatic cancer is associated with debilitating pain. Delaying these symptoms can preserve a patient’s overall quality of life, a promising outcome we observed in this trial," said Teresa Macarulla, MD, PhD, Medical Oncologist at Hospital Universitari Vall d’Hebron and Head of the Gastrointestinal and Endocrine Tumors Group at the Vall d’Hebron Institute of Oncology (VHIO). "The overall survival and quality of life results in PANOVA-3 support Tumor Treating Fields therapy with gemcitabine and nab-paclitaxel as a potential standard of care for unresectable, locally advanced pancreatic cancer."

The PANOVA-3 trial evaluated the use of TTFields therapy concomitantly with gemcitabine and nab-paclitaxel (GnP) as a first-line treatment for unresectable, locally advanced pancreatic adenocarcinoma, compared to GnP alone. The trial met its primary endpoint, demonstrating a statistically significant improvement in median overall survival for patients treated with TTFields.

"The PANOVA-3 results illustrate that Tumor Treating Fields therapy can significantly improve clinical outcomes for patients, including overall survival, in unresectable, locally advanced pancreatic cancer," said Nicolas Leupin, MD, PhD, Chief Medical Officer, Novocure. "These new data show that Tumor Treating Fields therapy can also have a meaningful impact preserving patients’ quality of life by delaying worsening symptoms of pancreatic cancer. We look forward to submitting a premarket application for Tumor Treating Fields therapy to the FDA in the second half of 2025."

Results from PANOVA-3

The primary endpoint of overall survival and several secondary endpoints, including pain-free survival, from PANOVA-3 were previously reported at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago.

The additional secondary endpoint data to be presented at the ESMO (Free ESMO Whitepaper) Gastrointestinal Cancers Congress 2025 are the full quality of life outcomes as well as a post-hoc analysis of the time to first opioid use.

The quality of life outcomes were measured using the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) with the pancreatic cancer specific PAN26 addendum scales. The EORTC QLQ-C30 and the PAN26 measure global health status and function as well as symptoms including pain (irrespective of cause), pancreatic pain, and gastrointestinal symptoms.

There was a statistically significant delay in the time to deterioration in global health status for patients treated with TTFields concomitant with GnP compared to patients treated with GnP alone, with a median of 7.1 months compared to 5.7 months, respectively, p=0.023.

The delay in time to deterioration due to pain (irrespective of cause) was statistically significant in patients treated with TTFields concomitant with GnP compared to patients treated with GnP alone, with a median 10.1 months compared to 7.4 months, respectively, p=0.003.

Similarly, the delay in time to deterioration due to pancreatic pain was statistically significant in patients treated with TTFields concomitant with GnP compared to patients treated with GnP alone, with a median of 14.7 months compared to 10.2 months, respectively, p=0.006.

These results complement the statistically significant extension in pain-free survival reported at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting, which was defined as the time between randomization until a ≥20-point increase of pain using a visual analog scale (VAS) from baseline or death. Patients treated with TTFields concomitant with GnP had a median pain-free survival of 15.2 months compared to a median 9.1 months in the group treated with GnP alone; HR 0.74 (95% CI: 0.56–0.97) p=0.027.

All gastrointestinal symptom scales included in the EORTC QLQ-C30 and PAN26, except for indigestion and altered bowel habit, significantly favored patients treated with TTFields concomitant with GnP.

In a post-hoc analysis, time to first opioid use was significantly longer with TTFields and GnP compared to patients treated with GnP alone, with a median of 7.1 months compared to 5.4 months, respectively, p=0.046.

TTFields therapy was well-tolerated, no new safety signals were observed, and device related safety outcomes were consistent with prior clinical studies using TTFields. Mild to moderate skin adverse events (AEs) were the most common device-related AEs.

The company will also present two posters of preclinical data from its pancreatic cancer development program.

Data Presentation Details

Oral Presentation: Late Breaking Abstract #LBA3: PANOVA-3: Pain and quality of life (QoL) outcomes with Tumor Treating Fields (TTFields) therapy in patients with locally advanced pancreatic adenocarcinoma (LAPC)

Presenting Author: Teresa Macarulla, MD, PhD, Vall d’Hebron University Hospital, Vall d’Hebron Institute of Oncology (VHIO), Spain

Time and Location: July 3, 2:10 PM CEST / 8:10 AM EDT, Barcelona Room

Poster #311P: Effectiveness of tumor treating fields (TTFields) together with gemcitabine and nab-paclitaxel in pancreatic ductal adenocarcinoma (PDAC) preclinical models

Time and Location: July 3, 3:30 – 4:30 PM CEST / 9:30 – 10:30 AM EDT, Exhibition Area

Poster #316P: Pancreatic cancer cells are sensitized to FOLFIRINOX treatment by co-application with tumor treating fields (TTFields)

Time and Location: July 3, 3:30 – 4:30 PM CEST / 9:30 – 10:30 AM EDT, Exhibition Area

About PANOVA-3

PANOVA-3 is an international, prospective, randomized, open-label, controlled Phase 3 clinical trial designed to test the efficacy and safety of Tumor Treating Fields (TTFields) therapy used concomitantly with gemcitabine and nab-paclitaxel, as a first-line treatment for locally advanced pancreatic adenocarcinoma. Patients were randomized to receive either TTFields therapy concomitant with gemcitabine and nab-paclitaxel or gemcitabine and nab-paclitaxel alone.

The primary endpoint is overall survival. Secondary endpoints include progression-free survival, local progression-free survival, objective response rate, one-year survival rate, quality of life, pain-free survival, puncture-free survival, resectability rate, and toxicity.

The PANOVA-3 trial enrolled 571 patients who were randomized 1:1 and followed for a minimum of 18 months.

About Pancreatic Cancer

Pancreatic cancer is one of the most lethal cancers and is the third most frequent cause of death from cancer in the U.S.i and the fifth most frequent cause in Europe.ii While overall cancer incidence and death rates are remaining stable or declining, the incidence and death rates for pancreatic cancer are increasing.iii It is estimated that approximately 67,000 patients are diagnosed with pancreatic cancer each year in the U.S.iv and the global incidence is more than 500,000.v Pancreatic cancer has a five-year relative survival rate of just 13%.vi

Physicians use different combinations of surgery, radiation and pharmacological therapies to treat pancreatic cancer, depending on the stage of the disease. For patients with locally advanced pancreatic cancer involving encasement of arteries but no extra-pancreatic disease, the standard of care is surgery followed by chemotherapy with or without radiation. Unfortunately, most locally advanced cases are diagnosed when the cancer is no longer operable, generally leaving chemotherapy with or without radiation as the only treatment option.

About Tumor Treating Fields

Tumor Treating Fields (TTFields) are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. These multiple, distinct mechanisms work together to target and kill cancer cells. Due to these multimechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and demonstrates enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or targeted therapies in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors.

To learn more about TTFields therapy and its multifaceted effect on cancer cells, visit tumortreatingfields.com.