METIS Phase 3 Clinical Trial Met Primary Endpoint Significantly Delaying Time to Intracranial Progression with Improved Quality of Life Deterioration-Free Survival
Novocure (NASDAQ: NVCR) announced that the METIS Phase 3 clinical trial met its primary endpoint, significantly delaying intracranial progression in patients with brain metastases from non-small cell lung cancer (NSCLC) using Tumor Treating Fields (TTFields) therapy. The trial demonstrated a median time to intracranial progression of 21.9 months for patients treated with TTFields therapy and supportive care, compared to 11.3 months for those with supportive care alone. Quality of life deterioration-free survival was also notably prolonged in the TTFields group, with no evidence of worsening cognitive function. The data will be presented at the 2024 ASCO Annual Meeting. Key secondary endpoints did not achieve statistical significance, with median overall survival at 11.3 months for the TTFields group versus 10.6 months for supportive care alone. Novocure plans to publish these findings and submit them to regulatory authorities.
- METIS trial met its primary endpoint.
- Median time to intracranial progression was 21.9 months with TTFields therapy versus 11.3 months with supportive care alone.
- Quality of life deterioration-free survival was significantly longer in the TTFields group.
- No evidence of worsening cognitive functioning in TTFields group.
- TTFields therapy was well-tolerated with no additive systemic toxicity.
- Positive trend observed in most quality of life measures.
- TTFields therapy could potentially change the treatment of brain metastases from NSCLC.
- Key secondary endpoints did not achieve statistical significance.
- Median overall survival was 11.3 months with TTFields therapy versus 10.6 months with supportive care alone.
Insights
The METIS Phase 3 clinical trial results are quite significant for the treatment of brain metastases from non-small cell lung cancer (NSCLC). The standout data point is the 21.9 months median time to intracranial progression in patients treated with Tumor Treating Fields (TTFields) therapy and supportive care, compared to 11.3 months for those with supportive care alone. This indicates a
Another notable aspect is the quality of life deterioration-free survival. Patients receiving TTFields therapy had not reached the median time for deterioration, compared to 7.7 months in the control group (P=0.038). This statistic is important because it highlights the therapy's ability to maintain patients' quality of life, a critical factor in cancer treatment.
Interestingly, there was no evidence of worsening cognitive function, which is often a major concern with brain-related treatments. This lack of cognitive decline aligns with prior studies, enhancing the credibility of TTFields therapy's safety profile.
However, it's important to note that the median overall survival was similar between the two groups, suggesting that while TTFields therapy delays intracranial progression, it does not significantly extend overall survival.
From a clinical perspective, the METIS trial results are promising for the treatment of brain metastases in NSCLC. The therapy’s ability to significantly delay intracranial progression without negatively impacting cognitive function or quality of life is noteworthy. These findings suggest a potential new standard of care for patients who currently have limited treatment options.
The therapy’s well-tolerated profile is another important point. The absence of additional systemic toxicity means that TTFields therapy can be integrated into existing treatment regimens without adding significant side effects, which is a common issue with many cancer therapies.
While the overall survival benefit was not statistically significant, the delay in intracranial progression can provide meaningful clinical benefits, such as reduced neurological symptoms and delayed need for further interventions. This aspect alone can improve a patient's quality of life and potentially reduce healthcare costs associated with additional treatments.
From a financial perspective, Novocure's announcement is likely to have a positive impact on investor sentiment. The significant delay in intracranial progression and improvement in quality of life metrics enhance the potential marketability of TTFields therapy for brain metastases in NSCLC.
This could translate into increased adoption by healthcare providers and potentially higher revenue for Novocure, especially if the findings are published in a peer-reviewed journal and receive regulatory approval, as planned. The results also differentiate Novocure’s offering in the competitive oncology market, potentially leading to new partnerships or expansion opportunities.
Investors should, however, be cautious about the lack of significant overall survival benefit. This could temper some of the enthusiasm, as extending overall survival is often a key metric for long-term success in cancer therapies.
The METIS trial demonstrated 21.9 months median time to intracranial progression for patients treated with TTFields therapy and supportive care compared to 11.3 months for patients treated with supportive care alone
Patients treated with TTFields therapy experienced prolonged quality of life deterioration-free survival and TTFields therapy was well-tolerated
Data from the METIS trial to be presented today during the 2024 ASCO Annual Meeting
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The METIS trial enrolled 298 adult patients with 1-10 brain metastases from NSCLC, who were randomized following stereotactic radiosurgery (SRS) to receive either TTFields therapy and best supportive care (BSC) (n=149) or BSC alone (n=149). METIS met its primary endpoint, demonstrating a statistically significant improvement in time to intracranial progression. Patients treated with TTFields therapy and BSC exhibited a median time to intracranial progression of 21.9 months compared to 11.3 months in patients treated with BSC alone (hazard ratio=0.67; P=0.016). Median TTFields therapy duration was 16 weeks and median usage was
Patients treated with TTFields therapy demonstrated improved quality of life deterioration-free survival, with median time to quality of life deterioration-free survival not reached in the TTFields therapy cohort compared to 7.7 months in control arm (P=0.038). A positive trend was observed in patients treated with TTFields therapy in the majority of scales and items assessed by the EORTC QLQ C30 and BN20 patient questionnaire. There was no evidence of worsening cognitive functioning in the TTFields therapy arm compared to the control arm. Consistent with prior clinical trials, TTFields therapy was well-tolerated with no additive systemic toxicity.
Preliminary analyses of key secondary endpoints did not demonstrate statistical significance. Median overall survival for patients randomized to receive TTFields therapy and BSC was 11.3 months compared to 10.6 months in patients treated with BSC alone. Full analysis of secondary endpoints is ongoing.
“One of the key challenges in combatting the spread of brain metastases is maintaining patients’ quality of life and cognitive function,” said lead investigator Minesh Mehta, MD, Chief of Radiation Oncology and Deputy Director at Miami Cancer Institute, part of Baptist Health South Florida. “The ability of TTFields therapy to prolong the time to intracranial progression without negatively impacting either quality of life or cognitive function has the potential to change the way brain metastases from non-small cell lung cancer are treated.”
“Despite the high incidence level of brain metastases from NSCLC, the treatment options available for patients are very limited,” said Nicolas Leupin, MD, Novocure’s Chief Medical Officer. “The observations from the METIS trial are an important first step in potentially adding a new treatment option for these patients and we are eager to pursue the necessary steps to ensure TTFields therapy is available to those in need.”
These data will be featured by Dr. Mehta in an oral presentation (abstract #2008) at 10:24 a.m. CDT on Monday, June 3, 2024 during ASCO’s Central Nervous System Tumors session. Novocure intends to publish these findings in a peer-reviewed scientific journal and submit these data to regulatory authorities.
About METIS
METIS [NCT02831959] is a phase 3 trial of stereotactic radiosurgery with or without TTFields therapy for patients with 1-10 brain metastases from NSCLC. 298 adult patients were enrolled in the trial and randomized to receive either TTFields therapy with supportive care or supportive care alone following SRS. Supportive care consisted of, but was not limited to, treatment with steroids, anti-epileptic drugs, anticoagulants, pain control or nausea control medications. Patients in both arms of the study were eligible to receive systemic therapy for their NSCLC at the discretion of their treating physician. Patients with known tumor mutations for which targeted agents are available were excluded from the trial.
The primary endpoint of the METIS trial is time to first intracranial progression, as measured from the date of first SRS treatment to intracranial progression or neurological death (per RANO-BM criteria), whichever occurs first. Time to intracranial progression was calculated according to the cumulative incident function. Patient scans were evaluated by a blinded, independent radiologic review committee. Secondary endpoints include, but are not limited to, time to distant progression, time to neurocognitive failure, overall survival, time to second intracranial progression, quality of life and adverse events. Key secondary endpoints (time to neurocognitive failure, overall survival, and radiological response rate) were planned to be used in labeling claims, if successful. Full analysis of secondary endpoints is ongoing. Patients were stratified by the number of brain metastases (1-4 or 5-10 metastases), prior systemic therapy, and tumor histology. Patients were allowed to crossover to the experimental TTFields therapy arm following confirmation of second intracranial progression.
About Tumor Treating Fields Therapy
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. The multiple, distinct mechanisms of TTFields therapy work together to selectively target and kill cancer cells. Due to its 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 Tumor Treating Fields 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 and malignant 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.
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INVESTORS AND MEDIA:
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media@novocure.com
Source: Novocure
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