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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

See safety summary

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 histologies1,3

  • 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 rates1,2

95% CI: 50%-72%.


95% CI: 28%-55%.

Radiological response rate1,2

§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 MPM1,4

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-100LTM System in Combination with Chemotherapy for the Treatment of Malignant Pleural Mesothelioma [press release]. St. Helier, Jersey: Business Wire; May 23, 2019.

Caution: Federal law restricts this device to sale by or on the order of a physician. Humanitarian Device. Authorized by Federal Law for use in the treatment of adult patients with unresectable, locally advanced or metastatic, malignant pleural mesothelioma concurrently with pemetrexed and platinum-based chemotherapy. The effectiveness of this device for this use has not been demonstrated.

 

Indication For Use

Optune Lua® is indicated for the treatment of adult patients with unresectable, locally advanced or metastatic, malignant pleural mesothelioma (MPM) to be used concurrently with pemetrexed and platinum-based chemotherapy.

 

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.

Novocure Websites

This website is intended for people seeking information on Optune Lua.

 

On this site, videos and images identified as Optune Lua users, care partners, or healthcare professionals depict actual patients, care partners, and healthcare professionals.

 

Patient images reflect the health status of the patients at the time each photo or video was taken.


External links

Tumortreatingfieldstherapy.com
Optunegio.com
Optunelua.com
Novocure.com
Novocuretrials.com


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US-OPL-00020 v1.0 August 2024