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BAAR, Switzerland - Novocure (NASDAQ: NVCR), a medical technology company with a market capitalization of $1.7 billion, has announced the CE Mark approval of Optune Lua for the treatment of metastatic non-small cell lung cancer (NSCLC) in adult patients. According to InvestingPro data, while the company’s stock has declined nearly 48% year-to-date, it maintains a strong balance sheet with more cash than debt. This approval allows the use of Optune Lua in conjunction with immune checkpoint inhibitors or docetaxel for patients who have seen disease progression after platinum-based therapies.
The Phase 3 LUNAR trial underpins this approval, revealing the first meaningful extension in median overall survival for this patient group in over eight years. Patients using Optune Lua alongside immune checkpoint inhibitors or docetaxel experienced a median overall survival extension of 3.3 months, a statistically significant improvement. This development comes as Novocure demonstrates strong revenue growth of 18.82% and maintains an impressive gross profit margin of 77.5%, according to recent financial data from InvestingPro.
Optune Lua is a wearable device that delivers Tumor Treating Fields (TTFields), an innovative treatment that disrupts cancer cell division through electric fields, leading to cell death. This non-invasive therapy has shown a lack of systemic toxicity, offering a promising option for patients.
The recent CE Mark follows the U.S. FDA’s approval in October 2024, and Novocure is preparing for the device’s launch in Germany, with further European expansion expected.
The LUNAR trial reported that patients treated with Optune Lua and an immune checkpoint inhibitor had a median overall survival of 18.5 months, significantly longer than the 10.8 months for those treated with an immune checkpoint inhibitor alone. While the combination with docetaxel did not reach statistical significance, it showed a positive trend.
Skin-related adverse events were the most common device-related side effect, with the majority being low-grade and manageable. No Grade 4 or Grade 5 toxicities or device-related deaths were reported.
Novocure will conduct a post-market study as part of the CE Mark conditions to further assess overall survival with TTFields and docetaxel in the routine care setting, comparing results with a control group treated with docetaxel alone.
NSCLC is the most common type of lung cancer, accounting for approximately 85% of cases, and represents a significant health burden in Europe, where over 400,000 new cases are diagnosed annually. The approval of Optune Lua offers a new therapeutic approach for patients with advanced stages of this disease. With Novocure’s stock currently trading below its InvestingPro Fair Value estimate, investors seeking deeper insights can access comprehensive analysis, including 6 additional ProTips and detailed financial metrics, through the Pro Research Report available on InvestingPro.
This news is based on a press release statement from Novocure.
In other recent news, Novocure reported its fourth-quarter financial results, revealing a mixed performance. The company experienced a wider-than-expected loss of $0.61 per share, missing analyst expectations by $0.25. However, it achieved a revenue of $161.26 million, surpassing the consensus estimate of $153.04 million and marking a 21% increase year-over-year. For the full year 2024, Novocure’s total net revenues were $605.2 million, reflecting a 19% growth from the previous year. This growth was largely driven by the successful launch of Optune Gio for glioblastoma in France and improved approval rates in the U.S. Novocure also announced the FDA approval of Optune Lua for treating metastatic non-small cell lung cancer, with its commercial rollout underway in the U.S. The company’s Phase 3 PANOVA-3 trial demonstrated a significant improvement in overall survival for pancreatic cancer patients. As of the end of 2024, Novocure reported having 4,126 active patients on its TTFields therapy globally. The company concluded the year with $959.9 million in cash, cash equivalents, and short-term investments.
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