FDA Approves Novocure’s Optune Lua® for the Treatment of Metastatic Non-Small Cell Lung Cancer
Novocure (NASDAQ: NVCR) announced FDA approval of Optune Lua® for treating adult patients with metastatic non-small cell lung cancer (mNSCLC) who have progressed on or after platinum-based therapy. Optune Lua is approved for concurrent use with PD-1/PD-L1 inhibitors or docetaxel.
The approval is based on the Phase 3 LUNAR study, which demonstrated a statistically significant 3.3-month extension in median overall survival for patients treated with Optune Lua. Patients receiving Optune Lua with a PD-1/PD-L1 inhibitor showed a remarkable 8.0-month extension in median overall survival compared to PD-1/PD-L1 inhibitor alone.
Optune Lua is a wearable device that delivers Tumor Treating Fields (TTFields), which exert physical forces on dividing cancer cells, resulting in cell death. The treatment showed a favorable safety profile with mostly low-grade skin-related adverse events.
Novocure (NASDAQ: NVCR) ha annunciato l'approvazione della FDA per Optune Lua® nel trattamento di pazienti adulti con cancro polmonare non a piccole cellule metastatici (mNSCLC) che sono progrediti dopo o durante la terapia a base di platino. Optune Lua è approvato per l'uso concomitante con inibitori PD-1/PD-L1 o docetaxel.
L'approvazione si basa sullo studio LUNAR di Fase 3, che ha dimostrato un'estensione statisticamente significativa di 3,3 mesi nella sopravvivenza globale mediana per i pazienti trattati con Optune Lua. I pazienti che ricevevano Optune Lua con un inibitore PD-1/PD-L1 hanno mostrato un'impressionante estensione di 8,0 mesi nella sopravvivenza globale mediana rispetto all'inibitore PD-1/PD-L1 da solo.
Optune Lua è un dispositivo indossabile che eroga Campi per il Trattamento dei Tumori (TTFields), i quali esercitano forze fisiche sulle cellule cancerose in divisione, portando alla morte cellulare. Il trattamento ha mostrato un profilo di sicurezza favorevole con eventi avversi cutanei per lo più di grado basso.
Novocure (NASDAQ: NVCR) anunció la aprobación de la FDA para Optune Lua® para el tratamiento de pacientes adultos con cáncer de pulmón no microcítico metastásico (mNSCLC) que han progresado tras la terapia basada en platino. Optune Lua está aprobado para su uso concurrente con inhibidores de PD-1/PD-L1 o docetaxel.
La aprobación se basa en el estudio LUNAR de Fase 3, que demostró una extensión estadísticamente significativa de 3.3 meses en la supervivencia general mediana para los pacientes tratados con Optune Lua. Los pacientes que recibieron Optune Lua junto con un inhibidor de PD-1/PD-L1 mostraron una notable extensión de 8.0 meses en la supervivencia general mediana en comparación con el inhibidor de PD-1/PD-L1 solo.
Optune Lua es un dispositivo portátil que entrega Campos de Tratamiento de Tumores (TTFields), que ejercen fuerzas físicas sobre las células cancerosas en división, resultando en la muerte celular. El tratamiento mostró un perfil de seguridad favorable con eventos adversos relacionados con la piel en su mayoría de bajo grado.
Novocure (NASDAQ: NVCR)는 Optune Lua®가 백금 기반 치료 후에 진행된 전이성 비소세포 폐암 (mNSCLC) 성인 환자를 치료하는 데 FDA 승인을 받았다고 발표했습니다. Optune Lua는 PD-1/PD-L1 억제제 또는 독소루비신과 함께 사용하도록 승인되었습니다.
이 승인은 3상 LUNAR 연구를 기반으로 하며, 이 연구에서 Optune Lua로 치료받은 환자들의 중앙 전체 생존 기간이 통계적으로 유의미하게 3.3개월 연장되었습니다. PD-1/PD-L1 억제제와 함께 Optune Lua를 받은 환자는 PD-1/PD-L1 억제제 단독 치료에 비해 중앙 전체 생존 기간이 8.0개월 연장되는 놀라운 결과를 보였습니다.
Optune Lua는 종양 치료 장치인 Tumor Treating Fields (TTFields)를 전달하는 착용 가능한 장치입니다. TTFields는 분열 중인 암 세포에 물리적 힘을 가하여 세포 사멸을 유도합니다. 치료는 대부분 저등급 피부 관련 부작용이 발생하는 것으로, 안전성 프로필이 우수한 것으로 나타났습니다.
Novocure (NASDAQ: NVCR) a annoncé l'approbation par la FDA de Optune Lua® pour le traitement des patients adultes atteints de cancer du poumon non à petites cellules métastatique (mNSCLC) ayant progressé après ou pendant une thérapie à base de platine. Optune Lua est approuvé pour une utilisation conjointe avec des inhibiteurs de PD-1/PD-L1 ou du docetaxel.
L'approbation repose sur l'étude de phase 3 LUNAR, qui a démontré une augmentation statistiquement significative de 3,3 mois de la survie médiane globale des patients traités avec Optune Lua. Les patients recevant Optune Lua avec un inhibiteur de PD-1/PD-L1 ont montré une extension remarquable de 8,0 mois de la survie médiane globale par rapport à ceux recevant uniquement l'inhibiteur de PD-1/PD-L1.
Optune Lua est un dispositif portable qui délivre des Champs de Traitement des Tumeurs (TTFields), qui exercent des forces physiques sur les cellules cancéreuses se divisant, entraînant la mort cellulaire. Ce traitement a montré un profil de sécurité favorable avec des événements indésirables cutanés majoritairement de faible gravité.
Novocure (NASDAQ: NVCR) gab die FDA-Zulassung für Optune Lua® zur Behandlung von Erwachsenen mit metastasiertem nicht kleinzelligem Lungenkrebs (mNSCLC) bekannt, die nach oder während einer Therapie mit Platin fortgeschritten sind. Optune Lua ist zur gleichzeitigen Anwendung mit PD-1/PD-L1-Hemmern oder Docetaxel zugelassen.
Die Zulassung basiert auf der Phase-3 LUNAR-Studie, die eine statistisch signifikante Verlängerung der medianen Gesamtüberlebenszeit um 3,3 Monate bei Patienten gezeigt hat, die mit Optune Lua behandelt wurden. Patienten, die Optune Lua in Kombination mit einem PD-1/PD-L1-Hemmer erhielten, zeigten eine bemerkenswerte Verlängerung der medianen Gesamtüberlebenszeit um 8,0 Monate im Vergleich zu den alleinigen PD-1/PD-L1-Hemmern.
Optune Lua ist ein tragbares Gerät, das Tumorbehandlungsfelder (TTFields) abgibt, die physikalische Kräfte auf sich teilende Krebszellen ausüben, was zum Zelltod führt. Die Behandlung zeigte ein günstiges Sicherheitsprofil mit überwiegend niedriggradigen, hautbezogenen Nebenwirkungen.
- FDA approval of Optune Lua for mNSCLC treatment
- 3.3-month extension in median overall survival in Phase 3 LUNAR study
- 8.0-month extension in median overall survival when used with PD-1/PD-L1 inhibitors
- First substantial improvement in median overall survival in over 8 years for this patient population
- Favorable safety profile with mostly low-grade adverse events
- 63.1% of patients experienced device-related adverse events, mainly skin-related disorders
- 4% of patients experienced Grade 3 skin toxicity requiring treatment break
- No statistically significant benefit shown when used with docetaxel
Insights
The FDA approval of Optune Lua for metastatic non-small cell lung cancer (mNSCLC) represents a significant advancement in treatment options. Key points:
- First substantial improvement in median overall survival in over 8 years for this patient population
- Extends median overall survival by
3.3 months when used with PD-1/PD-L1 inhibitors or docetaxel - Particularly effective with PD-1/PD-L1 inhibitors, showing a
8.0 month survival benefit - Novel mechanism using Tumor Treating Fields (TTFields) to disrupt cancer cell division
- Generally well-tolerated with mostly low-grade skin-related side effects
This approval provides a much-needed option for patients who have progressed after platinum-based therapy, potentially changing the standard of care for second-line treatment in mNSCLC.
The LUNAR study results supporting Optune Lua's approval are compelling:
- Statistically significant
33.3% increase in median overall survival (13.2 vs 9.9 months) - Nearly doubled survival when combined with PD-1/PD-L1 inhibitors (19.0 vs 10.8 months)
- Positive trend with docetaxel, though not statistically significant
- Well-balanced patient characteristics across cohorts
- Manageable safety profile with no Grade 4 or 5 toxicities
The device's non-invasive nature and lack of systemic side effects make it an attractive option. However, long-term data on quality of life and potential resistance mechanisms will be important for understanding Optune Lua's full impact on mNSCLC treatment landscape.
This FDA approval is a major catalyst for Novocure (NVCR), potentially expanding its addressable market significantly:
- Estimated 30,000 patients annually seek second-line treatment for stage 4 NSCLC in the U.S.
- NSCLC accounts for
85% of lung cancers, the leading cause of cancer-related deaths worldwide - Approval for use with both immunotherapy and chemotherapy broadens applicability
- First-of-its-kind treatment in this indication could drive rapid adoption
Investors should watch for:
- Reimbursement decisions and market access strategies
- International expansion plans, particularly in high-incidence markets
- Potential label expansions to earlier treatment lines or other cancer types
The first treatment of its kind for metastatic NSCLC, Optune Lua is approved for use concurrently with PD-1/PD-L1 inhibitors or docetaxel in adult patients with metastatic NSCLC who progressed on or after a platinum-based regimen
Results of the pivotal Phase 3 LUNAR trial represent the first substantial improvement in median overall survival in more than 8 years for this patient population
Optune Lua is a wearable treatment that delivers Tumor Treating Fields (TTFields), which exert physical forces on the electrically charged components of dividing cancer cells, resulting in cell death
ROOT,
“Novocure is committed to extending survival in some of the most aggressive and difficult to treat cancers. The approval of Optune Lua brings a new and urgently needed option for people with metastatic NSCLC who have progressed while on or after platinum-based chemotherapy,” said Asaf Danziger, CEO, Novocure. “We are grateful to the patients, caregivers, investigators and healthcare providers who supported the clinical trials that led to this approval.”
Optune Lua is a portable device that produces alternating electric fields known as tumor treating fields (TTFields), which are delivered through non-invasive, wearable arrays. TTFields exert physical forces on the electrically charged components of dividing cancer cells, resulting in cell death.
“There have been a number of important advances in first-line treatment for NSCLC, but this is an aggressive disease, and most patients will develop progression, with limited effective treatment options in second line and beyond,” said Ticiana Leal, MD, Associate Professor and Director of the Thoracic Oncology Program at the Winship Cancer Institute of Emory University School of Medicine and primary investigator of the LUNAR study. “The overall survival results we observed with Optune Lua in the LUNAR study mark the first substantial improvement in more than 8 years in this patient population which, when combined with Optune Lua’s lack of systemic toxicity, make this a compelling development for many patients and their physicians who need better treatment options for this advanced disease.”
"We are excited patients with metastatic NSCLC have more options, which they urgently need,” said GO2 for Lung Cancer Chief Patient Officer Danielle Hicks. “The fight against lung cancer is always evolving, and the number of people affected by this disease is underappreciated. That is why Novocure’s commitment to advancing treatment is exciting for the whole lung cancer community.”
Data Supporting the Optune Lua Approval
The Phase 3 LUNAR study was a prospective, randomized, open-label, multicenter study that compared the use of Optune Lua concurrent with PD-1/PD-L1 inhibitors or docetaxel (experimental arm) to PD-1/PD-L1 inhibitors or docetaxel alone (control arm) for patients with metastatic NSCLC who progressed during or after platinum-based therapy.
The primary endpoint of the study was achieved demonstrating a statistically significant and clinically meaningful 3.3-month (P=0.04) extension in median overall survival (OS) for patients treated with Optune Lua concurrently with a PD-1/PD-L1 inhibitor or docetaxel (n=145). The group treated with Optune Lua concurrently with a PD-1/PD-L1 inhibitor or docetaxel had a median OS of 13.2 months (
The LUNAR study included two pre-specified powered secondary endpoints. The first secondary endpoint, which met statistical significance, assessed median OS in patients treated with Optune Lua concurrently with a PD-1/PD-L1 inhibitor versus a PD-1/PD-L1 inhibitor alone. The second secondary endpoint, which showed a positive trend but did not meet statistical significance, assessed Optune Lua concurrently with docetaxel versus docetaxel alone.
Patients randomized to Optune Lua and a PD-1/PD-L1 inhibitor (n=70) demonstrated a median OS of 19.0 months (
Patients randomized to receive Optune Lua and docetaxel (n=75) had a median OS of 11.1 months (
Device-related adverse events (AEs) occurred in
Baseline patient characteristics were well balanced between cohorts: median age was 65 years (range, 22-86);
Non-Small Cell Lung Cancer (NSCLC)
Lung cancer is the most common cause of cancer-related death worldwide1, and non-small cell lung cancer (NSCLC) accounts for approximately
Physicians use different combinations of surgery, radiation and pharmacological therapies to treat NSCLC, depending on the stage of the disease. Surgery, which may be curative in a subset of patients, is usually used in early stages of the disease. Since 1991, radiation with a combination of platinum-based chemotherapy drugs has been the first-line standard of care for locally advanced or metastatic NSCLC. Certain immune checkpoint inhibitors, including both PD-1 and PD-L1 inhibitors, have been approved for the first-line treatment of NSCLC and the standard of care in this setting continues to evolve rapidly.
It is estimated that approximately 30,000 patients actively seek treatment for stage 4 NSCLC after progressing during or after platinum-based therapy each year in the
What is Optune Lua® approved to treat?
Optune Lua is a wearable, portable, FDA-approved device used together with PD-1/PD-L1 inhibitors (immunotherapy) or docetaxel. It is indicated for adult patients with metastatic non-small cell lung cancer (mNSCLC) who have progressed on or after a platinum-based regimen.
Important Safety Information
Who should not use Optune Lua?
Optune Lua for mNSCLC is not for everyone. Talk to your doctor if you have:
- An electrical implant. Use of Optune Lua together with electrical implants has not been tested and may cause the implanted device not to work properly
- A known sensitivity to gels like the gel used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes. 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 allergies such as a fall in blood pressure and difficulty breathing
Do not use Optune Lua if you are pregnant or are planning to become pregnant. It is not known if Optune Lua is safe or effective during pregnancy.
What should I know before using Optune Lua?
Optune Lua should only be used after receiving training from qualified personnel, such as your doctor, a nurse, or other medical staff who have completed a training course given by Novocure®, the maker of Optune Lua.
- Do not use any parts that did not come with Optune Lua Treatment Kit sent to you by Novocure or given to you by your doctor
- Do not get the device or transducer arrays wet
- Please be aware that Optune Lua has a cord that plugs into an electrical socket. Be careful of tripping when it's connected
- If you have an underlying serious skin condition where the transducer arrays are placed, discuss with your doctor whether this may prevent or temporarily interfere with Optune Lua treatment
What are the possible side effects of Optune Lua?
The most common side effects of Optune Lua when used together with certain immunotherapy and chemotherapy drugs were dermatitis, pain in the muscles, bones, or joints, fatigue, anemia, alopecia (hair loss), dyspnea, nausea, cough, diarrhea, anorexia, pruritus (itching), leukopenia, pneumonia, respiratory tract infection, localized edema (swelling), rash, pain, constipation, skin ulcers, hypokalemia (low potassium levels), hypoalbuminemia (low albumin levels), hyponatremia (low sodium levels), and dysphagia (difficulty swallowing).
Other potential adverse effects associated with the use of Optune Lua include treatment related skin irritation, allergic reaction to the adhesive or to the gel, overheating of the array leading to pain and/or local skin burns, infections at 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/skin ulcer. Talk to your doctor if you have any of these side effects or questions.
About Tumor Treating Fields
Tumor Treating Fields (TTFields) are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. These multiple, distinct mechanisms work together to target and kill cancer cells. Due to these multimechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and demonstrates enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or targeted therapies in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors.
To learn more about TTFields therapy and its multifaceted effect on cancer cells, visit tumortreatingfields.com.
About Novocure
Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer through the development and commercialization of its innovative therapy, Tumor Treating Fields. Novocure’s commercialized products are approved in certain countries for the treatment of adult patients with glioblastoma, malignant pleural mesothelioma and pleural mesothelioma. Novocure has ongoing or completed clinical studies investigating Tumor Treating Fields in brain metastases, gastric cancer, glioblastoma, liver cancer, non-small cell lung cancer, pancreatic cancer and ovarian cancer.
Headquartered in Root,
Forward-Looking Statements
In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Novocure’s current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, clinical study progress, development of potential products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, coverage, collections from third-party payers and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as “could,” “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or other words and terms of similar meaning. Novocure’s performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, environmental, regulatory and political conditions and other more specific risks and uncertainties facing Novocure such as those set forth in its Annual Report on Form 10-K filed on February 22, 2024, and subsequent filings with the
_________________________
1 World Health Organization Lung Cancer Fact Sheet. Accessed October 3, 2024. https://www.who.int/news-room/fact-sheets/detail/lung-cancer#:~:text=Lung%20cancer%20is%20the%20leading%20cause%20of%20cancer-related%20deaths%20worldwide,
View source version on businesswire.com: https://www.businesswire.com/news/home/20241015381082/en/
Investors:
Ingrid Goldberg
investorinfo@novocure.com
Media:
Catherine Falcetti
media@novocure.com
Source: Novocure
FAQ
What is Optune Lua approved to treat for NVCR?
What were the key results of the LUNAR study for NVCR's Optune Lua?
How does NVCR's Optune Lua work to treat cancer?
What are the main side effects of NVCR's Optune Lua?
