Novocure to Present Final Results from the Pivotal Phase 3 METIS Trial of its Tumor Treating Fields (TTFields) Therapy for Brain Metastases from Non-Small Cell Lung Cancer at 2025 ASTRO Annual Meeting

METIS trial achieved its primary endpoint, showing a statistically significant delay in time to intracranial progression in patients receiving TTFields therapy and best supportive care following stereotactic radiation of the metastases

Results from the METIS trial published in the International Journal of Radiation Oncology Biology and Physics

Novocure (NASDAQ: NVCR) announced that final results from the Phase 3 METIS trial of Tumor Treating Fields (TTFields) therapy for brain metastases from non-small cell lung cancer (NSCLC) will be presented today at the 2025 American Society for Radiation Oncology (ASTRO) Annual Meeting taking place September 27 – October 1 in San Francisco and simultaneously published in the International Journal of Radiation Oncology Biology and Physics (Red Journal).

"Lung cancer patients with brain metastases are living longer due to improved systemic therapies, bringing to the forefront an unmet need for well-tolerated treatment options that provide more durable control of brain metastases," said Vinai Gondi, MD, Director of Radiation Oncology in the Northwestern Medicine West Region and Proton Center, Clinical Associate Professor of Radiation Oncology at Northwestern University Feinberg School of Medicine. "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 and practice-impacting step forward in providing patients with a new treatment option."

The METIS trial evaluated the use of TTFields therapy and best supportive care (BSC) to treat adult patients with 1-10 newly diagnosed brain metastases from NSCLC following stereotactic radiosurgery (SRS) compared to BSC alone. The trial met its primary endpoint, showing a statistically significant delay in time to first intracranial progression for patients who received TTFields therapy and BSC compared to patients receiving BSC alone.

"One of the challenges in treating patients with primary lung cancer is the high incidence of brain metastases in this population. When Tumor Treating Fields therapy was used to treat patients in the METIS trial, we saw a significant delay in the progression of intracranial metastases without adding systemic toxicity or causing neurocognitive side effects associated with other current treatments," said Nicolas Leupin, MD, PhD, Chief Medical Officer, Novocure. "We plan to submit our premarket approval application to the FDA for the treatment of adult patients with brain metastases from non-small cell lung cancer in the coming weeks."

Results from Pivotal Phase 3 METIS Trial

The pivotal Phase 3 METIS trial enrolled 298 adult patients with 1-10 brain metastases from NSCLC, who were randomized to receive either TTFields therapy and BSC (n=149) or BSC alone (n=149) following SRS of their brain metastases. Systemic anti-cancer therapy was allowed to treat the primary disease.

The primary endpoint of the METIS trial was defined as the time to intracranial progression (TTIP), as measured from the date of first SRS treatment to intracranial progression or neurological death, whichever occurred first.

When accounting for competing risks using the Fine–Gray method, patients treated with TTFields therapy and BSC experienced a 28% lower risk of intracranial progression compared to those receiving BSC alone (HR 0.72, p=0.044). The median time to intracranial progression was 15.0 months in patients treated with TTFields therapy and BSC compared to 7.5 months in patients treated with BSC alone.

Intracranial progression rates in both groups were measured at specific time points up to 24 months. At 2 months, those patients treated with TTFields therapy and BSC had a 13.6% progression rate compared to 22.1% (p=0.034) in those treated with BSC alone. At 6 months a 33.7% progression rate compared to 46.4% (p=0.018) was observed; at 12 months a 46.9% progression rate compared to 59.4% (p=0.023) was observed and at 24 months the rate was 53.6% compared to 65.2% (p=0.031; post hoc), in those patients treated with TTFields therapy and BSC compared to those treated with BSC alone, respectively.

There was no significant difference observed in the secondary endpoint measures of neurocognitive failure, overall survival or radiological response of brain lesions (measured with MRI).

Time to distant intracranial progression (TTDP) trended in favor of TTFields therapy with a median time to distant progression of 18.6 months for patients treated with TTFields therapy and BSC, and 11.3 months in the BSC alone arm, HR 0.76, p=0.165.

In the 118 patients in the TTFields group who received immune checkpoint inhibitors (ICI) for their primary disease during their participation in the METIS study, the beneficial effects observed on TTIP and TTDP were more pronounced, HR=0.63 and HR=0.41, post hoc, respectively.

TTFields therapy did not cause quality of life deterioration overall in the measured outcomes. Improvements in deterioration-free survival and time to deterioration of the global health status, physical functioning and fatigue domains were observed in patients treated with TTFields therapy.

Median duration of TTFields therapy was 16 weeks and median usage was 67%. Baseline patient demographics and characteristics were well balanced across the arms of the study.

The safety profile of TTFields therapy was consistent with that seen in other clinical trials. Grade 1/2 skin issues were the most common device-related adverse events and subcutaneous tissue events.

Data Presentation & Publication Details

The Phase 3 METIS data, (LBA 03) Tumor Treating Fields (TTFields) After Stereotactic Radiosurgery (SRS) for Brain Metastases from Non-Small Cell Lung Cancer (NSCLC BM): Final Results of The Phase 3 METIS Trial, will be presented by Dr. Gondi September 29 during the 1:30 – 3:00 PM PT Plenary session in the San Francisco Ballroom at the Moscone Center.

The Phase 3 METIS publication in the International Journal of Radiation Oncology Biology and Physics (Red Journal), "Tumor Treating Fields (TTFields) therapy after stereotactic radiosurgery for brain metastases from non-small cell lung cancer: final results of the phase 3 METIS study", will be available online at www.redjournal.org.

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, non-small cell lung cancer, malignant pleural mesothelioma and pleural mesothelioma. Novocure has several additional ongoing or completed clinical trials exploring the use of Tumor Treating Fields therapy in the treatment of glioblastoma, non-small cell lung cancer and pancreatic cancer.

Novocure's global headquarters is located in Baar, Switzerland, with U.S. headquarters located in Portsmouth, New Hampshire and research and development facilities located in Haifa, Israel. For additional information about the company, please visit Novocure.com and follow @Novocure on LinkedIn and Twitter.

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