This site is intended for US healthcare professionals only

NOW FDA-APPROVED for mNSCLC

For adult patients with mNSCLC concurrent with a PD-1/PD-L1 inhibitor or docetaxel after progression on or after a platinum-based regimen

Attack the electrical vulnerability of NSCLC cells to extend 2L+ survival1

See overall survival data

24% reduction in the risk of death1

HR: 0.76 (95% CI: 0.58-0.99); P=0.041

The first significant OS improvement demonstrated by a 2L+ mNSCLC treatment in 8 years1,2

Review the pivotal LUNAR study

Optune Lua did not add systemic toxicity. Dermatologic adverse events (dAEs) were the only device-related AEs (occurring in >5% of patients), and were observed in 63.1% of patients (n=89/141)1,3

 

  • Majority were mild-to-moderate (grade 1 to 2)1
  • Only 6 patients (4%) reported a grade 3 skin toxicity that required a break from treatment; in all cases the skin issue resolved1
  • There were no grade 4 or grade 5 toxicities related to Optune Lua, and no device-related AEs that caused death1

 

The LUNAR Study was a phase 3, open-label, randomized study testing the safety and effectiveness of Optune Lua together with a PD-1/PD-L1 inhibitor or docetaxel for patients with mNSCLC who progressed on or after platinum-based therapy (N=291)1,*

 

  • Patients were 1:1 randomized to receive either Optune Lua + a PD-1/PD-L1 inhibitor or docetaxel vs a PD-1/PD-L1 inhibitor or docetaxel alone
  • Primary endpoint: OS with Optune Lua + a PD-1/PD-L1 inhibitor or docetaxel vs a PD-1/PD-L1 inhibitor or docetaxel alone

An innovative approach for treating 2L+ mNSCLC that has progressed on or after platinum-based therapy

Optune Lua is a noninvasive, wearable treatment designed to fit into your patient's everyday life1

What is Optune Lua?

Optune Lua uses electrical fields to disrupt cancer cell viability without affecting healthy cells1

See how it works

Partnering with your patients and practice at every step of the journey 

MyNovocure® is here to help with points of contact and personalized assistance for your practice and your patients who are prescribed Optune Lua

Learn more about MyNovocure

*After interim analysis, the independent data monitoring committee recommended reducing patient accrual to 276 patients with 12 months follow-up. Initial planned accrual was 534 patients with 18 months follow-up. The final enrollment was 291. The expected hazard ratio for overall survival was <0.75.1,4

 

2L+, second line or after; AE, adverse event; FDA, US Food and Drug Administration; mOS, median overall survival; NSCLC, non–small cell lung cancer; OS, overall survival; PD-1/PD-L1, programmed cell death 1 protein/programmed cell death 1 ligand 1; SAE, serious adverse event.

 

References: 1. Optune Lua for Non-Small Cell Lung Cancer (NSCLC). Physician Instructions for Use. Novocure; 2024. 2. Novocure Data on File 2024. US-DOF-0040. 3. Novocure Data on File 2024. US-DOF-0042. 4. Leal T, Kotecha R, Ramlau R, et al. Lancet Oncol. 2023;24(9):1002-1017. 5. Leal T, Kotecha R, Ramlau R, et al. Supplementary appendix. Lancet Oncol. 2023;24(9):1002-1017. Accessed March 21, 2024. https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(23)00344-3/fulltext

Important Safety Information 

Contraindications 

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

 

Do not use Optune Lua in patients known to be sensitive to conductive hydrogels. In this case, skin contact with the gel used with Optune Lua may commonly cause increased redness and itching, and rarely may even lead to severe allergic reactions, such as a fall in blood pressure and breathing difficulty.

Warnings and Precautions 

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

 

Do not prescribe Optune Lua for patients who are pregnant, whom you think might be pregnant, or who are trying to get pregnant, as the safety and effectiveness of Optune Lua in these populations have not been established. 

 

The most common (≥10%) adverse events involving Optune Lua concurrent with PD-1/PD-L1 inhibitors or docetaxel were dermatitis, musculoskeletal pain, fatigue, anemia, dyspnea, nausea, cough, diarrhea, anorexia, pruritus, leukopenia, pneumonia, respiratory tract infection, localized edema, rash, pain, constipation, skin ulcers, and hypokalemia. 

 

Other potential adverse effects associated with the use of Optune Lua include treatment related skin toxicity, allergic reaction to the adhesive or to the gel, overheating of the array leading to pain and/or local skin burns, infections at the site where the arrays make contact with the skin, local warmth and tingling sensation beneath the arrays, medical device site reaction, muscle twitching, and skin breakdown or skin ulcer. 

 

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

 

Indication For Use

Optune Lua is intended as a treatment concurrent with PD-1/PD-L1 inhibitors or docetaxel for adult patients with metastatic non-small cell lung cancer who have progressed on or after a platinum-based regimen. 

 


Please see full Instructions For Use (IFU) and Patient Information and Operation Manual (PIOM) for Optune Lua®.

Important Safety Information 

Contraindications 

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

 

Do not use Optune Lua in patients known to be sensitive to conductive hydrogels. In this case, skin contact with the gel used with Optune Lua may commonly cause increased redness and itching, and rarely may even lead to severe allergic reactions, such as a fall in blood pressure and breathing difficulty.

Warnings and Precautions 

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

 

Do not prescribe Optune Lua for patients who are pregnant, whom you think might be pregnant, or who are trying to get pregnant, as the safety and effectiveness of Optune Lua in these populations have not been established. 

 

The most common (≥10%) adverse events involving Optune Lua concurrent with PD-1/PD-L1 inhibitors or docetaxel were dermatitis, musculoskeletal pain, fatigue, anemia, dyspnea, nausea, cough, diarrhea, anorexia, pruritus, leukopenia, pneumonia, respiratory tract infection, localized edema, rash, pain, constipation, skin ulcers, and hypokalemia. 

 

Other potential adverse effects associated with the use of Optune Lua include treatment related skin toxicity, allergic reaction to the adhesive or to the gel, overheating of the array leading to pain and/or local skin burns, infections at the site where the arrays make contact with the skin, local warmth and tingling sensation beneath the arrays, medical device site reaction, muscle twitching, and skin breakdown or skin ulcer. 

 

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

 

Indication For Use

Optune Lua is intended as a treatment concurrent with PD-1/PD-L1 inhibitors or docetaxel for adult patients with metastatic non-small cell lung cancer who have progressed on or after a platinum-based regimen. 

 


Please see full Instructions For Use (IFU) and Patient Information and Operation Manual (PIOM) for Optune Lua®.

Novocure Websites

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

 

 

 

 


External links

OptuneGioHCP.com
OptuneLuaHCP.com/MPM
Novocuretrials.com


©2024 Novocure GmbH. All Rights Reserved. 

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

US-OPL-00070 v1.0 November 2024