Novocure Reports Positive Phase 3 Results for TTFields Therapy in Pancreatic Cancer

ROOT, Switzerland--Novocure (NASDAQ: NVCR) has announced a breakthrough in the treatment of pancreatic cancer with its Phase 3 PANOVA-3 trial. This pivotal trial demonstrated a significant improvement in median overall survival (mOS) for patients with unresectable, locally advanced pancreatic adenocarcinoma. The trial tested the efficacy of Tumor Treating Fields (TTFields) therapy in combination with gemcitabine and nab-paclitaxel as a first-line treatment.

Vincent Picozzi, M.D., a medical oncologist and investigator in the PANOVA-3 trial, expressed his enthusiasm for the results. He emphasized the challenges in developing treatments for pancreatic cancer and highlighted the trial's achievement as a landmark outcome for the field. The data showed that patients receiving TTFields therapy along with the standard chemotherapy regimen had an mOS of 16.20 months compared to 14.16 months for those receiving chemotherapy alone. This represents a statistically significant improvement of 2.0 months (hazard ratio=0.819; P=0.039) among the 571 patients enrolled in the study.

The trial also demonstrated a survival rate benefit for patients treated with TTFields therapy, with a 13% improvement in the overall survival rate at 12 months and a 33% improvement at 24 months. The therapy was well-tolerated, and safety profiles were consistent with previous clinical studies.

Nicolas Leupin, M.D., Ph.D., Chief Medical Officer of Novocure, noted that PANOVA-3 is the first and only Phase 3 trial to show a significant benefit in overall survival for patients with unresectable, locally advanced pancreatic cancer. He acknowledged the contributions of the patients and investigators, expressing hope to present the full data at an upcoming medical conference.

Following the success of PANOVA-3, Novocure plans to seek regulatory approval for TTFields therapy in the treatment of unresectable, locally advanced pancreatic adenocarcinoma. They also aim to present the results at a forthcoming medical congress.

Additionally, Novocure is conducting the Phase 2 PANOVA-4 trial, which investigates the use of TTFields therapy in combination with atezolizumab, gemcitabine, and nab-paclitaxel for metastatic pancreatic cancer. Enrollment for PANOVA-4 is complete, with data expected in 2026.

The PANOVA-3 trial was a prospective, randomized, open-label, controlled Phase 3 clinical trial designed to assess the efficacy and safety of TTFields therapy with standard chemotherapy for locally advanced pancreatic adenocarcinoma. The primary endpoint was overall survival, with secondary endpoints including 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.

Pancreatic cancer remains one of the deadliest cancers, accounting for the third highest number of cancer-related deaths in the U.S. Despite stable or declining rates for other cancers, the incidence and mortality rates for pancreatic cancer are on the rise. Approximately 67,000 new cases are diagnosed annually in the U.S., with a five-year relative survival rate of just 13%. Treatment typically involves a combination of surgery, radiation, and chemotherapy, but many cases are diagnosed too late for surgery, leaving chemotherapy as the primary option.

TTFields are electric fields that target and kill cancer cells through various mechanisms. Unlike healthy cells, cancer cells are vulnerable to these fields due to their distinct properties. TTFields therapy can be integrated with other cancer treatments, enhancing their effects across various solid tumors.

Novocure, a global oncology company, is dedicated to extending survival in aggressive cancers through its innovative TTFields therapy. The company’s products are approved in multiple countries for treating glioblastoma, non-small cell lung cancer, malignant pleural mesothelioma, and other cancers. Novocure continues to explore the potential of TTFields therapy in ongoing clinical trials for various cancers.