{"entity":{"id":"panova-3","kind":"trial","name":"PANOVA-3","aka":[],"tldr":"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.","status":"positive","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT03377491","url":"https://clinicaltrials.gov/study/NCT03377491"},{"label":"Babiker et al., PANOVA-3 (JCO 2025)","url":"https://doi.org/10.1200/JCO-25-00746"}],"tags":[],"related":[],"cancers":["pancreatic","locally-advanced-pdac"],"sections":[],"technologies":["ttfields"],"targets":[],"drugs":["optune","gemcitabine-nab-paclitaxel"],"companies":["novocure"],"institutions":[],"pathways":[],"terms":[],"trials":["mpact","lap07","conko-007"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"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."],"nct":"NCT03377491","phase":"3","setting":"Unresectable locally advanced PDAC: TTFields + gemcitabine/nab-paclitaxel vs chemotherapy alone","sponsor":"Novocure","result":"OS 16.2 vs 14.2 months, HR 0.82.","started":"2018-05-10","startedType":"actual","yearReported":2025,"enrolled":571,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"TTFields + gemcitabine/nab-paclitaxel","n":284,"value":16.2},{"name":"Gemcitabine/nab-paclitaxel","n":287,"value":14.2}],"hr":0.82,"ci":[0.68,0.99],"p":"0.039","source":"https://ascopubs.org/doi/10.1200/JCO.25.00361"},{"endpoint":"Pain-free survival","unit":"months","arms":[{"name":"TTFields + gemcitabine/nab-paclitaxel","value":15.2,"note":"95% CI 10.3 to 22.8"},{"name":"Gemcitabine/nab-paclitaxel","value":9.1,"note":"95% CI 7.4 to 12.7"}],"hr":0.74,"ci":[0.56,0.97],"p":"0.027","source":"https://doi.org/10.1200/JCO-25-00746"}],"replication":"Single pivotal trial; open-label design and modest effect size are debated."},"route":"/trials/panova-3/","neighbours":{"cancer":[{"id":"locally-advanced-pdac","kind":"cancer","name":"Locally advanced unresectable pancreatic ductal adenocarcinoma","route":"/cancers/locally-advanced-pdac/"},{"id":"pancreatic","kind":"cancer","name":"Pancreatic ductal adenocarcinoma","route":"/cancers/pancreatic/"}],"technology":[{"id":"ttfields","kind":"technology","name":"Tumour treating fields (TTFields)","route":"/technologies/ttfields/"}],"drug":[{"id":"gemcitabine-nab-paclitaxel","kind":"drug","name":"Gemcitabine + nab-paclitaxel","route":"/drugs/gemcitabine-nab-paclitaxel/"},{"id":"optune","kind":"drug","name":"Optune / Optune Pax (TTFields)","route":"/drugs/optune/"}],"company":[{"id":"novocure","kind":"company","name":"Novocure","route":"/companies/novocure/"}],"trial":[{"id":"conko-007","kind":"trial","name":"CONKO-007","route":"/trials/conko-007/"},{"id":"lap07","kind":"trial","name":"LAP07","route":"/trials/lap07/"},{"id":"mpact","kind":"trial","name":"MPACT","route":"/trials/mpact/"}],"paper":[{"id":"paper-panova-3-ttfields-locally-advanced-pancreatic-jco-2025","kind":"paper","name":"Tumor Treating Fields With Gemcitabine and Nab-Paclitaxel for Locally Advanced Pancreatic Adenocarcinoma: Randomized, Open-Label, Pivotal Phase III PANOVA-3 Study","route":"/key-papers/paper-panova-3-ttfields-locally-advanced-pancreatic-jco-2025/"}],"roadmap":[{"id":"devices-roadmap","kind":"roadmap","name":"Devices and physical therapies roadmap: heat and light → electric fields and focused sound → drug-releasing implants","route":"/roadmaps/devices-roadmap/"},{"id":"pancreatic-roadmap","kind":"roadmap","name":"Pancreatic cancer roadmap: from Whipple's operation to gemcitabine, FOLFIRINOX, adjuvant chemotherapy, PARP inhibition, KRAS inhibition, vaccines and the surveillance question","route":"/roadmaps/pancreatic-roadmap/"}]}}