Progressive shares fall as Q3 earnings, revenue miss expectations
SAN FRANCISCO - Novocure (NASDAQ:NVCR), a $1.45 billion medical technology company with a robust 76.5% gross margin, announced Monday that its Phase 3 METIS trial demonstrated a statistically significant delay in brain metastases progression in non-small cell lung cancer (NSCLC) patients treated with Tumor Treating Fields (TTFields) therapy. According to InvestingPro analysis, while the company maintains strong cash reserves, it currently operates at a loss, highlighting the importance of successful clinical trials for future growth.
The study results, presented at the American Society for Radiation Oncology Annual Meeting and published in the International Journal of Radiation Oncology Biology and Physics, showed patients receiving TTFields therapy and best supportive care following stereotactic radiosurgery experienced a 28% lower risk of intracranial progression compared to those receiving best supportive care alone. Despite showing promising clinical results, the company’s stock has declined 56.7% year-to-date, though InvestingPro’s Fair Value analysis suggests the stock may be currently undervalued.
Median time to intracranial progression was 15.0 months for patients in the TTFields group versus 7.5 months in the control group. The trial enrolled 298 adult patients with 1-10 brain metastases from NSCLC.
"The METIS trial, demonstrating that the addition of Tumor Treating Fields following stereotactic radiosurgery delays brain metastasis progression with no negative impact on quality of life or neurocognition, is a pivotal step forward in providing patients with a new treatment option," said Dr. Vinai Gondi, Director of Radiation Oncology in the Northwestern Medicine West Region.
The company plans to submit a premarket approval application to the FDA for this indication in the coming weeks, according to Nicolas Leupin, Novocure’s Chief Medical Officer.
TTFields therapy did not cause quality of life deterioration, and improvements were observed in several measured outcomes. The safety profile was consistent with previous clinical trials, with Grade 1/2 skin issues being the most common device-related adverse events. With revenue growth of 14.6% over the last twelve months, Novocure continues to expand its market presence. For deeper insights into Novocure’s financial health and growth prospects, including exclusive ProTips and comprehensive analysis, visit InvestingPro, where you’ll find detailed research reports covering 1,400+ top stocks.
The company noted that in the 118 patients who also received immune checkpoint inhibitors for their primary disease, the beneficial effects were more pronounced.
TTFields are electric fields that exert physical forces to kill cancer cells through various mechanisms while not significantly affecting healthy cells, according to information provided in the company’s press release statement.
In other recent news, Novocure has received approval from Japan’s Ministry of Health, Labour and Welfare for its Optune Lua device, intended for use with PD-1/PD-L1 inhibitors in adult patients with advanced or recurrent non-small cell lung cancer. This approval is backed by the Phase 3 LUNAR trial, which showed a notable improvement in median overall survival for patients using Optune Lua. Despite this, Novocure announced the termination of its LUNAR-4 clinical trial for metastatic non-small cell lung cancer, citing the availability of real-world evidence. Additionally, Spain’s Ministry of Health has approved Novocure’s Tumor Treating Fields therapy for inclusion in the Spanish National Health System for newly diagnosed glioblastoma patients. In the United States, Novocure has submitted a premarket approval application to the FDA for its Tumor Treating Fields therapy aimed at treating locally advanced pancreatic cancer. Ladenburg Thalmann has initiated coverage on Novocure with a Buy rating, citing optimism for the company’s Optune Gio treatment in maintaining its market position in glioblastoma multiforme. These developments highlight Novocure’s ongoing efforts to expand its treatment options across various cancer types.
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