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2022 World Conference on Lung Cancer (ePosters)
EP08.01-076. KEYNOTE B36: A Pilot Study of First-l ...
EP08.01-076. KEYNOTE B36: A Pilot Study of First-line Tumor Treating Fields (150 kHz) Plus Pembrolizumab for Advanced or Metastatic Non-small Cell Lung Cancer
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A pilot study is being conducted to evaluate the efficacy and safety of Tumor Treating Fields (TTFields) therapy in combination with pembrolizumab as a first-line treatment for advanced or metastatic non-small cell lung cancer (NSCLC). TTFields therapy is a non-invasive treatment modality that uses alternating electric fields to disrupt mitosis and prevent tumor growth. It has been approved for the treatment of glioblastoma and unresectable malignant pleural mesothelioma.<br /><br />The study is based on promising Phase 1/2 data that showed TTFields therapy in combination with chemotherapy had positive results in recurrent NSCLC. The study involves the use of the NovoTTF-200T system, a portable and wearable medical device that delivers TTFields therapy.<br /><br />Preclinical data has indicated that TTFields can induce immunogenic cell death and adding TTFields treatment to anti-PD-1 therapy reduced tumor volume in vivo. This supports the hypothesis that combining TTFields therapy with pembrolizumab, an immune checkpoint inhibitor, may increase the response rate and duration of response in patients with advanced or metastatic NSCLC.<br /><br />The study, known as KEYNOTE B36, is a multicenter, single-arm, open-label Phase 2 study designed to evaluate the safety and efficacy of TTFields therapy plus pembrolizumab as a first-line treatment for advanced NSCLC. The primary endpoint of the study is objective response rate, while secondary endpoints include overall survival, progression-free survival, and safety.<br /><br />The study aims to enroll 66 patients and will compare the results to a historical control of pembrolizumab monotherapy. The study is currently enrolling patients at various sites throughout the United States.<br /><br />In summary, this pilot study is investigating the combination of TTFields therapy and pembrolizumab as a potential first-line treatment option for advanced or metastatic NSCLC. Preclinical data and previous clinical trials have shown promising results, and this study aims to further evaluate the efficacy and safety of this treatment approach.
Asset Subtitle
Rupesh Kotecha
Meta Tag
Speaker
Rupesh Kotecha
Topic
Metastatic Non-small Cell Lung Cancer - Immunotherapy
Keywords
pilot study
efficacy
safety
Tumor Treating Fields therapy
TTFields
pembrolizumab
first-line treatment
advanced NSCLC
metastatic NSCLC
NovoTTF-200T system
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