Safety

Optune Lua did not add systemic toxicity¹

Serious adverse events (SAEs) in LUNAR

AE, adverse event; PD-1/PD-L1, programmed cell death 1 protein/programmed cell death 1 ligand 1.

The rate of SAEs did not differ clinically or significantly when accounting for follow-up time¹
No difference in the rate of grade 3-4 pneumonitis (1.4% for Optune Lua + PD-1/PD-L1 inhibitor or docetaxel vs 2.1% for PD-1/PD-L1 inhibitor or docetaxel)²
No difference in the rate of other systemic AEs²

The only device-related AEs (>5%) were skin-related and mild to moderate^1,2,*

Device-related dAEs²

*≥5% of patients in any group and all grade 3+ adverse events.²

Dermatologic adverse events (dAEs) under the transducer arrays were experienced by 63.1% of patients (n=89/141)¹
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

Dermatologic AE treatment guidance

Review quality-of-life data

AE, adverse event; IO, immuno-oncology agent (nivolumab, pembrolizumab, or atezolizumab).

References: 1. Optune Lua for Non-Small Cell Lung Cancer (NSCLC). Physician Instructions for Use. Novocure; 2024. 2. Novocure Data on File US-DOF-0046.  

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^®.