Novocure (NVCR) Announces FDA IDE Approval and Steering Committee for KEYNOTE-B36 Trial Evaluating Tumor Treating Fields Together with Pembrolizumab in NSCLC

April 22, 2021 8:48 AM EDT

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Novocure (NASDAQ: NVCR) today announced that the U.S. Food and Drug Administration (FDA) has approved its investigational device exemption (IDE) application to initiate the KEYNOTE-B36 trial, conducted in collaboration with MSD (Merck & Co., Inc., Kenilworth, NJ, USA). Novocure also announced the members of its scientific steering committee who will provide expert opinions and recommendations regarding enrollment strategies, country distribution, study timelines and other scientific topics. The KEYNOTE-B36 trial will evaluate Tumor Treating Fields (TTFields) together with pembrolizumab for first-line treatment of locally advanced or metastatic intrathoracic, PD-L1 positive non-small cell lung cancer (NSCLC).

KEYNOTE-B36 steering committee members include:

  • Corey Langer, M.D., director of thoracic oncology and professor of medicine at the Hospital of the University of Pennsylvania
  • Anne S. Tsao, M.D., professor and section chief of thoracic medical oncology and director of the mesothelioma program at The University of Texas MD Anderson Cancer Center
  • Vinicius Ernani, M.D., Senior Associate Consultant at Mayo Clinic
  • Rupesh Kotecha, M.D., radiation oncologist and chief of radiosurgery at Miami Cancer Institute

“In vivo data suggest that using TTFields together with anti-PD-1 therapy results in increased tumor response versus either therapy alone,” said Asaf Danziger, Novocure’s Chief Executive Officer. “We are honored to have such an esteemed group of key opinion leaders join the KEYNOTE-B36 steering committee as we look to translate our preclinical knowledge into clinical data demonstrating the effect of TTFields together with pembrolizumab in first-line NSCLC. With the FDA IDE approval, we are now working closely with trial sites, investigators and institutional review boards to open sites and enroll patients as quickly as possible.”

About KEYNOTE-B36

KEYNOTE-B36 is a phase 2 pilot trial conducted in collaboration with MSD (Merck & Co., Inc., Kenilworth, NJ, USA). KEYNOTE-B36 will evaluate the effectiveness of TTFields together with pembrolizumab for first-line treatment of locally advanced or metastatic intrathoracic, PD-L1 positive NSCLC. Objective response rate (ORR) is the primary endpoint of the study. Secondary endpoints include overall survival, progression free survival (PFS), PFS at six months, one-year survival rate, duration of response, disease control rate at 18 weeks and safety. The study is designed to enroll approximately 66 patients in the United States.



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