FDA Approves Optune Lua® as First-of-its-Kind Treatment for Metastatic Non-Small Cell Lung Cancer
Novocure (NASDAQ: NVCR) announced that the U.S. Food and Drug Administration (FDA) has approved Optune Lua®, a groundbreaking treatment for metastatic non-small cell lung cancer (mNSCLC). The device is approved for use in combination with PD-1/PD-L1 inhibitors or docetaxel for adult patients who have progressed after receiving a platinum-based chemotherapy regimen. Optune Lua is the first treatment of its kind for this patient population, marking a significant advancement in the fight against this aggressive form of cancer.
The approval is based on the results of the Phase 3 LUNAR trial, which showed the first substantial improvement in median overall survival for patients with mNSCLC in over eight years. Patients treated with Optune Lua, in combination with either PD-1/PD-L1 inhibitors or docetaxel, experienced a 3.3-month extension in median overall survival compared to those treated with the inhibitors or docetaxel alone.
How Optune Lua Works
Optune Lua is a portable, wearable device that delivers Tumor Treating Fields (TTFields) through non-invasive arrays. These alternating electric fields disrupt the division of cancer cells, resulting in cell death. Unlike traditional cancer therapies, Optune Lua exerts its effects through physical forces on electrically charged components of dividing cancer cells, without systemic toxicity.
“Optune Lua’s approval offers a much-needed option for people with metastatic NSCLC who have few effective treatments available after their cancer progresses on platinum-based chemotherapy,” said Asaf Danziger, CEO of Novocure. “We are grateful to the patients, caregivers, and medical professionals who supported the clinical trials that led to this important milestone.”
LUNAR Study Results
The Phase 3 LUNAR trial was a multicenter, randomized, open-label study that compared the use of Optune Lua in combination with PD-1/PD-L1 inhibitors or docetaxel against the inhibitors or docetaxel alone. The study met its primary endpoint, with patients treated with Optune Lua showing a median overall survival of 13.2 months, compared to 9.9 months for those receiving inhibitors or docetaxel alone.
Further, patients treated with Optune Lua in combination with PD-1/PD-L1 inhibitors saw a median overall survival of 19 months—an 8-month improvement over the inhibitor-only group. Patients treated with Optune Lua and docetaxel saw a 2.2-month improvement in survival compared to those treated with docetaxel alone, although this did not reach statistical significance.
Minimal Systemic Toxicity
Optune Lua offers a promising alternative for patients who have developed resistance to other therapies. Dr. Ticiana Leal, Associate Professor at Emory University’s School of Medicine and the LUNAR trial’s primary investigator, highlighted the importance of these findings. “This is a major step forward for mNSCLC patients. The substantial improvement in survival, combined with the lack of systemic toxicity, makes this a compelling option for many patients who need better second-line treatments,” she said.
Device-related adverse events were primarily skin-related disorders under the transducer arrays, with most cases being mild. Less than 4% of patients experienced Grade 3 skin toxicity, and no severe or life-threatening device-related events were reported.
Lung Cancer Impact and Treatment Evolution
Lung cancer remains the leading cause of cancer-related deaths globally, with non-small cell lung cancer accounting for about 85% of cases. In the U.S. alone, approximately 193,000 new cases of NSCLC are diagnosed each year, and around 30,000 patients seek treatment for stage 4 mNSCLC after their cancer progresses on platinum-based therapies.
While first-line treatments such as immune checkpoint inhibitors have revolutionized the management of NSCLC, many patients still experience disease progression, highlighting the urgent need for new second-line treatment options.
What Optune Lua is Approved to Treat
Optune Lua is FDA-approved for the treatment of adult patients with metastatic NSCLC who have progressed on or after a platinum-based chemotherapy regimen. It is used in combination with PD-1/PD-L1 inhibitors or docetaxel, offering a novel non-invasive treatment option that has shown significant survival benefits in clinical trials.
Important Safety Information
Optune Lua is not suitable for everyone. Patients with electrical implants or a known sensitivity to gels used with the device should avoid using it. The device is not recommended for pregnant women or those planning to become pregnant, as its safety during pregnancy has not been established.
Before using Optune Lua, patients must receive training from qualified medical personnel. Proper usage is crucial, and users should avoid getting the device wet and be cautious of tripping hazards when the device is connected to an electrical socket.
Potential Side Effects
The most common side effects of Optune Lua when used with immunotherapy or chemotherapy drugs include dermatitis, muscle or joint pain, fatigue, anemia, hair loss, nausea, cough, and respiratory infections. Skin irritation at the site of the transducer arrays is also common, and some patients may experience more severe reactions, such as local skin burns or allergic reactions.
Patients are advised to consult their doctor regarding any side effects or concerns related to the use of Optune Lua.
Optune Lua represents a groundbreaking development in the treatment of metastatic NSCLC, offering hope to patients who have exhausted other treatment options. Novocure’s innovative device is poised to make a meaningful impact in the ongoing fight against lung cancer.
