This site is intended for US healthcare professionals only.

STUDY DESIGN

PANOVA-3: The largest positive phase 3 trial in locally advanced pancreatic cancer (LAPC)1,2

A global, randomized, open-label, phase 3 trial (N=571)3

138 study sites around the world1,3

  • North America, Europe, Middle East, Latin America, and Asia-Pacific

Primary endpoint3:

  • Overall survival

Secondary endpoints1,3:

  • Time to pain progression
  • Quality of life, including:
    • Time to deterioration of global heath status
    • Pain, pancreatic-specific pain, and digestive problems as measured by the EORTC QLQ C-30 questionnaire and PAN26 module
  • Progression-free survival
  • Local progression-free survival
  • Objective response rate

Baseline characteristics were well balanced between treatment arms3

Baseline demographics

Optune Pax with gem/nab-pac (n=285)

Gem/nab-pac (n=286)

Age, years

Median (range)

67 (31–90)

67.5 (40–88)

ECOG PS, %

0

38.2

38.8

1

58.2

57.0

2

3.5

4.2

Gender, %

Male

51.6

43.7

Female

48.4

56.3

Race, %

White

70.9

71.3

Asian

15.4

15.4

Black

5.6

4.9

Not reported

3.9

5.2

American Indian or Alaska Native

3.2

1.4

Other

1.1

1.7

Target lesion site, %

Head of the pancreas

57.5

55.9

Body of the pancreas

28.8

28.3

Tail of the pancreas

3.2

6.6

Other

19.3

17.1

PANOVA-3 is the first and only phase 3 trial in nearly 30 years to show median overall survival benefit in patients with locally advanced pancreatic cancer1

Explore the clinical data

AE=adverse event; ECOG PS=Eastern Cooperative Oncology Group Performance Status; EORTC QLQ-C30=European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30; gem/nab-pac=gemcitabine and nab-paclitaxel; PAN26=pancreatic cancer specific addendum to EORTC QLQ questionnaire; q4w=every 4 weeks; R=randomized.  

 

 

 

References: 1. Babiker HM, Picozzi V, Chandana SR, et al. Tumor treating fields with gemcitabine and nab-paclitaxel for locally advanced pancreatic adenocarcinoma: randomized, open-label, pivotal phase III PANOVA-3 study. J Clin Oncol. 2025;43(21):2350-2360. doi:10.1200/JCO-25-00746 2. Picozzi VJ, Babiker HM, Chandana SR, et al. LBA4005: PANOVA-3: phase 3 study of tumor treating fields (TTFields) with gemcitabine and nab-paclitaxel for locally advanced pancreatic ductal adenocarcinoma (LA-PAC). Accessed January 29, 2026. https://ascopubs.org/doi/10.1200/JCO.2025.43.17_suppl.LBA4005 3. Optune Pax for Locally Advanced Pancreatic Cancer (LAPC). Physician Instructions for Use. Novocure; 2026.

 

 

Indication for Use

Optune Pax® is intended for the treatment of adult patients with locally advanced pancreatic cancer, concomitant with gemcitabine and nab-paclitaxel.

Important Safety Information

Contraindications

Do not use Optune Pax in patients with an electrical implant. Use of Optune Pax together with electrical implants has not been tested and may lead to malfunctioning of the implanted device.

Do not use Optune Pax in patients with a known sensitivity to conductive hydrogels. In patients with this sensitivity, skin contact with the gel used with Optune Pax may commonly cause increased redness and itching. In rare cases, it may lead to severe allergic reactions that can cause a drop in blood pressure and difficulty breathing.

Warnings and Precautions

Optune Pax can only be prescribed by a healthcare provider who has completed the required certification training provided by Novocure® (the device manufacturer).

Do not prescribe Optune Pax for patients who are pregnant, who you think might be pregnant, or who are trying to get pregnant. Women who are able to get pregnant must use birth control when using the device. Safety and effectiveness of Optune Pax in these populations have not been established.

The most common (≥10%) adverse events involving Optune Pax concomitant with gemcitabine and nab-paclitaxel were neutropenia, anemia, thrombocytopenia, leukopenia, diarrhea, nausea, vomiting, abdominal pain, constipation, fatigue, peripheral edema, pyrexia, pain, COVID-19, infection, respiratory tract infection, urinary tract infection, pneumonia, hepatic enzyme increased, anorexia, hypokalemia, hypoalbuminemia, hyperglycemia, musculoskeletal pain, peripheral neuropathy, taste disorder, dizziness, sleep disorder, dyspnea, alopecia, skin-related disorders, and hypotension.

Optune Pax device-related skin adverse events (≥5%) include dermatitis, rash, pruritus, maculo-papular rash, erythema, skin irritation, skin reaction, and skin ulcer. Other device-related adverse effects associated with the use of Optune Pax include overheating of the array, leading to pain and/or local skin burns, allergic reaction to the adhesive or gel from the transducer arrays, and local warmth and tingling sensation beneath the arrays.

If the patient has an underlying skin condition on the abdomen, evaluate whether this may prevent or temporarily interfere with Optune Pax treatment.

Please see the Optune Pax Instructions for Use (IFU) for complete information regarding the device’s indication, contraindications, warnings, and precautions.

 

Indication for Use

Optune Pax® is intended for the treatment of adult patients with locally advanced pancreatic cancer, concomitant with gemcitabine and nab-paclitaxel.

Important Safety Information

Contraindications

Do not use Optune Pax in patients with an electrical implant. Use of Optune Pax together with electrical implants has not been tested and may lead to malfunctioning of the implanted device.

Do not use Optune Pax in patients with a known sensitivity to conductive hydrogels. In patients with this sensitivity, skin contact with the gel used with Optune Pax may commonly cause increased redness and itching. In rare cases, it may lead to severe allergic reactions that can cause a drop in blood pressure and difficulty breathing.

Warnings and Precautions

Optune Pax can only be prescribed by a healthcare provider who has completed the required certification training provided by Novocure® (the device manufacturer).

Do not prescribe Optune Pax for patients who are pregnant, who you think might be pregnant, or who are trying to get pregnant. Women who are able to get pregnant must use birth control when using the device. Safety and effectiveness of Optune Pax in these populations have not been established.

The most common (≥10%) adverse events involving Optune Pax concomitant with gemcitabine and nab-paclitaxel were neutropenia, anemia, thrombocytopenia, leukopenia, diarrhea, nausea, vomiting, abdominal pain, constipation, fatigue, peripheral edema, pyrexia, pain, COVID-19, infection, respiratory tract infection, urinary tract infection, pneumonia, hepatic enzyme increased, anorexia, hypokalemia, hypoalbuminemia, hyperglycemia, musculoskeletal pain, peripheral neuropathy, taste disorder, dizziness, sleep disorder, dyspnea, alopecia, skin-related disorders, and hypotension.

Optune Pax device-related skin adverse events (≥5%) include dermatitis, rash, pruritus, maculo-papular rash, erythema, skin irritation, skin reaction, and skin ulcer. Other device-related adverse effects associated with the use of Optune Pax include overheating of the array, leading to pain and/or local skin burns, allergic reaction to the adhesive or gel from the transducer arrays, and local warmth and tingling sensation beneath the arrays.

If the patient has an underlying skin condition on the abdomen, evaluate whether this may prevent or temporarily interfere with Optune Pax treatment.

Please see the Optune Pax Instructions for Use (IFU) for complete information regarding the device’s indication, contraindications, warnings, and precautions.

 

Novocure websites

This website is intended for US healthcare professionals seeking information on Optune Pax.

©2026 Novocure GmbH. All Rights Reserved.

Optune Gio, Optune Lua, Optune Pax, MyLink, MyNovocure, and Novocure are registered trademarks of Novocure GmbH.

All other trademarks, registered or unregistered, are the property of their respective owners.

US-OPP-00007 v1.0 March 2026