Novocure is seeking approval for its therapy in the US, EU and Japan. Image credit: crystal light / Shutterstock.

NovoCure is seeking regulatory approval in the US, EU, Japan and other key markets after the Phase III PANOVA-3 pancreatic cancer study met its endpoints.

The PANOVA-3 study (NCT03377491) met its primary endpoint, improving overall survival (OS) for patients with unresectable, locally advanced pancreatic adenocarcinoma treated in the first line with tumour treating fields (TTFields) therapy alongside chemotherapies, gemcitabine and nab-paclitaxel.

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Patients in the TTFields arm had an OS of 16.20 months compared to 14.16 months in patients treated with chemotherapy alone.

Patients treated with the TTFields therapy combination saw a 13% improvement in the overall survival rate at 12 months and a 33% improvement in survival rate at 24 months. TTFields therapy was well-tolerated, and safety was consistent with prior clinical studies.

The randomised, open-label trial was designed to test the efficacy and safety of TTFields with chemotherapy, as a first-line treatment of locally advanced pancreatic adenocarcinoma in 571 patients.

TTFields are electric fields that exert physical forces to kill cancer cells using a variety of mechanisms through a portable device placed on the skin near the tumour. TTFields do not significantly affect healthy cells because they have different properties including division rate, morphology, and electrical properties, Novocure claims.

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The Swiss-based biotech’s shares jumped by 40% today (2 December) following the announcement, from a close of $20.04 on 29 November and opened at $28.25 today.

Novocure CMO Dr Nicolas Leupin said: “PANOVA-3 is the first and only Phase III trial to demonstrate a statistically significant benefit in overall survival specifically in unresectable, locally advanced pancreatic cancer, and is Novocure’s third positive Phase III clinical trial in the last two years.”

Novocure will present full data from the PANOVA-3 study at an upcoming medical congress. The company will file for regulatory approval in the US, EU and Japan while its partner Zai Lab plans to file for approval in China.

Data from the ongoing Phase II PANOVA-4 trial (NCT06390059) is expected in 2026. The study is exploring the use of TTFields therapy with Tecentriq (atezolizumab), gemcitabine and nab-paclitaxel for the treatment of metastatic pancreatic cancer.

Novocure markets electric field wearable devices that have received approval such as Optune Gio for glioblastoma and Optune Lua for metastatic non-small cell lung cancer and a rare, aggressive cancer called mesothelioma. Last year, Novocure’s TTFields therapy failed to improve survival in ovarian cancer.