Zai Lab Partner Novocure Announces METIS Phase 3 Clinical Trial Met Primary Endpoint, Demonstrating a Statistically Significant Extension in Time to Intracranial Progression for Patients with Brain Metastases from Non-Small Cell Lung Cancer
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Insights
The METIS trial results indicating a significant extension in median time to intracranial progression for patients with brain metastases from non-small cell lung cancer (NSCLC) using Tumor Treating Fields (TTFields) therapy represent a pivotal development in oncology therapeutics. The doubling of time before disease progression from 11.3 to 21.9 months is a substantial improvement in patient outcomes. This could signal a shift in standard care practices for NSCLC patients with brain metastases, a common and typically hard-to-treat complication of lung cancer.
From a research perspective, the data suggests TTFields therapy could fill an unmet need in the existing treatment landscape. The median usage rate of 67% and a treatment duration of 16 weeks indicate a manageable commitment for patients, which may improve compliance rates. However, the lack of statistical significance in key secondary endpoints like overall survival and neurocognitive failure warrants cautious optimism. It is essential for stakeholders to await further analysis for a comprehensive understanding of the therapy's impact on these critical aspects of patient health.
The positive outcome of the METIS trial could have substantial implications for Novocure's market position and growth prospects. The results may lead to increased adoption of TTFields therapy, pending regulatory approval, which would likely result in significant revenue growth for Novocure. The therapy's well-tolerated profile, coupled with sustained quality of life and neurocognitive function, positions it favorably among treatment options, potentially increasing its attractiveness to both patients and healthcare providers.
For investors, these developments could be a harbinger of value creation, given that improved treatment options for NSCLC patients with brain metastases could lead to market expansion. It's important to monitor Zai Lab's role in the Greater China market, as successful penetration into this region could represent a considerable growth opportunity for the therapy. Nevertheless, investors should be mindful of the ongoing full analysis of secondary endpoints, which could further influence the therapy's commercial viability and adoption rate.
The clinical relevance of the METIS trial's findings cannot be overstated for practitioners in the field of oncology. The significant delay in intracranial progression for NSCLC patients with brain metastases treated with TTFields therapy is a remarkable advance, potentially altering the treatment algorithm for this patient population. As a treatment modality, TTFields therapy's non-invasiveness is a key advantage, potentially offering a better quality of life compared to more aggressive treatments.
However, it is critical to approach these results with a balanced perspective. The therapy's impact on overall survival and neurocognitive function, while showing positive trends, has not yet achieved statistical significance. This underscores the necessity for a multidisciplinary approach to patient management, integrating TTFields therapy with other systemic treatments and supportive care to optimize patient outcomes. The medical community eagerly awaits the full analysis of secondary endpoints and subsequent peer-reviewed publication to guide clinical decision-making.
The METIS trial demonstrated 21.9 months median time to intracranial progression for patients treated with Tumor Treating Fields and supportive care compared to 11.3 months for patients treated with supportive care alone
Preliminary analyses of key secondary endpoints (time to neurocognitive failure, overall survival, and radiological response rate) did not demonstrate statistical significance. Certain secondary endpoints showed positive trends in favor of treatment with TTFields therapy, including time to distant progression and quality of life. Full analysis of secondary endpoints is ongoing.
Novocure intends to submit these data to regulatory authorities. Novocure also intends to publish these findings in a peer-reviewed scientific journal and share them at an upcoming scientific congress.
Zai Lab contributed to the METIS trial and achieved treatment of the first patient in
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. 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 Brain Metastases from NSCLC in
Brain metastases are secondary tumors formed when cancer cells break away from the primary tumor and travel through the blood or lymph system to form new tumors (or metastases) in the brain. Brain metastases are a negative prognostic factor in NSCLC and adversely impact neurocognitive function and quality of life.
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Treatment options for patients with brain metastases from NSCLC are limited to neurosurgery, SRS, whole brain radiation therapy, or combinations of these options. However, given the neurotoxicity and significant decline in cognitive functioning, whole brain radiation therapy (WBRT) is an unfavorable treatment option. New therapeutic options are needed for greater intracranial control while minimizing the risk of neurocognitive adverse events.
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2 Ali, A., Goffin, J. R., Arnold, A., & Ellis, P. M. (2013). Survival of patients with non-small-cell lung cancer after a diagnosis of brain metastases. Current oncology (
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 PARP inhibition 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 Zai Lab
Zai Lab (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in
For additional information about Zai Lab, please visit www.zailaboratory.com or follow us at www.twitter.com/ZaiLab_Global.
Zai Lab Forward-Looking Statements
This press release contains forward-looking statements relating to the future expectations, plans, and prospects, for Zai Lab, including, without limitation, statements relating to Zai Lab’s prospects and plans for developing and commercializing TTFields, the potential benefits of TTFields, and the potential treatment for patients with brain metastases from NSCLC. These forward-looking statements may contain words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would,” and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact or guarantees or assurances of future performance. Forward-looking statements are based on Zai Lab’s expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) Zai Lab’s ability to successfully commercialize and generate revenue from the approved products, (2) Zai Lab’s ability to obtain funding for the operations and business initiatives, (3) the results of Zai Lab’s clinical and pre-clinical development of the product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of the product candidates, (5) risks related to doing business in
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