Efficacy

Primary endpoint: OS for Optune Lua + PD-1/PD-L1 inhibitor or docetaxel vs PD-1/PD-L1 inhibitor or docetaxel alone

Significantly extended mOS vs PD-1/PD-L1 inhibitor or docetaxel alone¹

ITT population

The 1-year OS rate was 53% (95% CI: 44-61) with Optune Lua + ICI^* or docetaxel vs 42% (95% CI: 34-50) with ICI^* or docetaxel alone¹

^*ICI refers to PD-1/PD-L1 inhibitor.¹

Key secondary endpoint: OS for Optune Lua + PD-1/PD-L1 inhibitor vs PD-1/PD-L1 inhibitor alone

Significant extended mOS benefit when used together with PD-1/PD-L1 inhibitor¹

PD-1/PD-L1 inhibitor group

The 1-year OS rate was 61% (95% CI: 48-72) with Optune Lua + ICI^* vs 46% (95% CI: 34-57) with ICI^*alone¹

^*ICI refers to PD-1/PD-L1 inhibitor.¹

Key secondary endpoint: OS for Optune Lua + docetaxel vs docetaxel alone

Clinically meaningful mOS in a heavily pretreated patient population¹

Docetaxel group

The 1-year survival rates were 46% (95% CI: 34-57) for Optune Lua + docetaxel vs 39% (95% CI: 28-50) for docetaxel alone¹

See the safety profile for Optune Lua

mOS, median overall survival; OS, overall survival; PD-1/PD-L1, programmed cell death 1 protein/programmed cell death 1 ligand 1.

Reference: 1. Optune Lua for Non-Small Cell Lung Cancer (NSCLC). Physician Instructions for Use. Novocure; 2024.

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 Luais 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 Luais 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^®.