# PANOVA-3

Source: https://onco.cc/trials/panova-3/  
OnCo record `panova-3` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

PANOVA-3 is the trial behind the 2026 approval of a wearable electric-field device for pancreatic cancer, the first new approval in locally advanced disease in decades.

## Summary

PANOVA-3, trial NCT03377491 sponsored by Novocure and reported in 2025, is the trial behind the 2026 approval of Optune Pax, a wearable electric-field device, for unresectable locally advanced pancreatic cancer, the first new approval in that setting in decades. It randomised 571 patients to tumour treating fields plus gemcitabine and nab-paclitaxel or chemotherapy alone, met its primary overall survival endpoint with a modest effect presented at the ASCO 2025 plenary, and also improved pain-free survival, leading to FDA approval in the first quarter of 2026. OnCo links it to pancreatic ductal adenocarcinoma, tumour treating fields, the Optune device record, gemcitabine plus nab-paclitaxel and Novocure. It is a single pivotal trial, and its open-label design and modest effect size are debated, so whether the device changes practice outside trial centres is the open question.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-06
- Registry id: NCT03377491
- Phase: 3
- Setting: Unresectable locally advanced PDAC: TTFields + gemcitabine/nab-paclitaxel vs chemotherapy alone
- Sponsor: Novocure
- Enrolled: 571
- Result: OS 16.2 vs 14.2 months, HR 0.82.
- Outcomes: Overall survival: TTFields + gemcitabine/nab-paclitaxel 16.2 months vs Gemcitabine/nab-paclitaxel 14.2 months, HR 0.82; Pain-free survival: TTFields + gemcitabine/nab-paclitaxel 15.2 months vs Gemcitabine/nab-paclitaxel 9.1 months, HR 0.74
- Replication: Single pivotal trial; open-label design and modest effect size are debated.

## Notes

- Primary paper (JCO 2025): pain-free survival 15.2 against 9.1 months (hazard ratio 0.74; p 0.027) and distant progression-free survival 13.9 against 11.5 months (hazard ratio 0.74; p 0.022) improved; progression-free survival, local control and response did not; device-related skin adverse events 76.3 percent, grade 3 in 7.7 percent. No UK sites; results posted to the registry January 2026; no NICE appraisal on 24 September 2026.

## Sources

- ClinicalTrials.gov NCT03377491: https://clinicaltrials.gov/study/NCT03377491
- Babiker et al., PANOVA-3 (JCO 2025): https://doi.org/10.1200/JCO-25-00746

## Connected records

- cancers: [Locally advanced unresectable pancreatic ductal adenocarcinoma](https://onco.cc/cancers/locally-advanced-pdac/), [Pancreatic ductal adenocarcinoma](https://onco.cc/cancers/pancreatic/)
- technologies: [Tumour treating fields (TTFields)](https://onco.cc/technologies/ttfields/)
- drugs: [Gemcitabine + nab-paclitaxel](https://onco.cc/drugs/gemcitabine-nab-paclitaxel/), [Optune / Optune Pax (TTFields)](https://onco.cc/drugs/optune/)
- companies: [Novocure](https://onco.cc/companies/novocure/)
- trials: [CONKO-007](https://onco.cc/trials/conko-007/), [LAP07](https://onco.cc/trials/lap07/), [MPACT](https://onco.cc/trials/mpact/)
- key papers: [Tumor Treating Fields With Gemcitabine and Nab-Paclitaxel for Locally Advanced Pancreatic Adenocarcinoma: Randomized, Open-Label, Pivotal Phase III PANOVA-3 Study](https://onco.cc/key-papers/paper-panova-3-ttfields-locally-advanced-pancreatic-jco-2025/)
- roadmaps: [Devices and physical therapies roadmap: heat and light → electric fields and focused sound → drug-releasing implants](https://onco.cc/roadmaps/devices-roadmap/), [Pancreatic cancer roadmap: from Whipple's operation to gemcitabine, FOLFIRINOX, adjuvant chemotherapy, PARP inhibition, KRAS inhibition, vaccines and the surveillance question](https://onco.cc/roadmaps/pancreatic-roadmap/)

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