This site is intended for US healthcare professionals only

Efficacy

STELLAR primary endpoint

STELLAR Clinical Results: Patients who used Optune Lua first line together with pemetrexed + cisplatin or carboplatin achieved 18.2 months median OS^1,2

Kaplan-Meier OS curve for the 80 study patients (95% CI: 12.1-25.8).²

The STELLAR study was a prospective, single-arm, phase 2 trial to study the safety and efficacy of Optune Lua first line in patients with unresectable, locally advanced or metastatic, malignant pleural mesothelioma (N=80). Patients were ≥18 years of age, had an ECOG performance status of 0-1, and at least one measurable or evaluable lesion according to mRECIST for MPM. Patients received continuous TTFields to the thorax at a frequency of 150 kHz for at least 18 hours/day and concomitant chemotherapy every 21 days for up to 6 cycles.²

Optune Lua and pemetrexed + cisplatin or carboplatin median OS results shown across histologies^1,3

21.2 months median OS in 66% of patients with epithelioid histology (2/3 of participants)
12.1 months in 34% of patients with less responsive, harder to treat nonepithelioid histology (1/3 of participants)^*

^*Nonepithelioid histology includes sarcomatoid or biphasic and unknown tumor pathology.

STELLAR secondary endpoints

STELLAR Clinical Results: Patients using Optune Lua achieved 7.6 months median progression-free survival (PFS) when used together with pemetrexed + cisplatin or carboplatin as first-line treatment (N=80)^1,2

95% CI: 6.7-8.6, across all patients treated

Survival rates^1,2

^†95% CI: 50%-72%.

^‡95% CI: 28%-55%.

Radiological response rate^1,2

^§In patients with at least one follow-up CT scan performed and were therefore evaluable for response according to mRECIST criteria.

Optune Lua is FDA approved as first-line therapy for patients with MPM^1,4

See FDA approval pathway

Next: Safety

AE, adverse event; CR, complete response; CT, computed tomography; ECOG, Eastern Cooperative Oncology Group; mRECIST, modified Response Evaluation Criteria in Solid Tumors; MPM, malignant pleural mesothelioma; PR, partial response; SD, stable disease; TTFields, Tumor Treating Fields.

References: 1. Optune Lua. Instructions for Use for Unresectable Malignant Pleural Mesothelioma. Novocure; 2021. 2. Ceresoli GL, Aerts JG, Dziadziuszko R, et al. Tumour Treating Fields in combination with pemetrexed and cisplatin or carboplatin as first-line treatment for unresectable malignant pleural mesothelioma (STELLAR): a multicentre, single-arm phase 2 trial. Lancet Oncol. 2019;20(12):1702-1709. doi:10.1016/S1470-2045(19)30532-7 3. Mansfield AS, Symanowski JT, Peikert T. Systematic review of response rates of sarcomatoid malignant pleural mesotheliomas in clinical trials. Lung Cancer. 2014;86(2):133-136. 4. FDA Approves the NovoTTF-100L^TM System in Combination with Chemotherapy for the Treatment of Malignant Pleural Mesothelioma [press release]. St. Helier, Jersey: Business Wire; May 23, 2019.

Important Safety Information

Contraindications

Do not use Optune Lua in patients with implantable electronic medical devices such as pacemakers or implantable automatic defibrillators, etc. Use of Optune Lua together with implanted electronic devices 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. Skin contact with the gel used with Optune Lua may commonly cause increased redness and itching, and may rarely lead to severe allergic reactions such as shock and respiratory failure.

Warnings and Precautions

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

The most common (≥10%) adverse events involving Optune Lua in combination with chemotherapy were anemia, constipation, nausea, asthenia, chest pain, fatigue, medical device site reaction, pruritus, and cough.

Other potential adverse effects associated with the use of Optune Lua include: treatment related skin toxicity, allergic reaction to the plaster or to the gel, electrode overheating leading to pain and/or local skin burns, infections at sites of electrode contact with the skin, local warmth and tingling sensation beneath the electrodes, muscle twitching, medical device site reaction and skin breakdown/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.

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

Please click here to see Optune Lua Instructions For Use (IFU) for complete information regarding the device's indications, contraindications, warnings, and precautions.

Efficacy

STELLAR primary endpoint

STELLAR Clinical Results: Patients who used Optune Lua first line together with pemetrexed + cisplatin or carboplatin achieved 18.2 months median OS1,2

Optune Lua and pemetrexed + cisplatin or carboplatin median OS results shown across histologies1,3

STELLAR secondary endpoints

STELLAR Clinical Results: Patients using Optune Lua achieved 7.6 months median progression-free survival (PFS) when used together with pemetrexed + cisplatin or carboplatin as first-line treatment (N=80)1,2

Survival rates1,2

Radiological response rate1,2

Optune Lua is FDA approved as first-line therapy for patients with MPM1,4

Indication For Use