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Novocure Announces Favorable Independent Data Monitoring Committee Recommendation to Continue Phase 3 PANOVA-3 Clinical Trial of Tumor Treating Fields Therapy in Pancreatic Cancer
Pre-specified interim analysis concluded that the fully enrolled PANOVA-3 clinical trial should proceed to final analysis as planned ROOT,
About this update from Novocure Limited
[{"type":"text","content":"\nPre-specified interim analysis concluded that the fully enrolled PANOVA-3 clinical trial should proceed to final analysis as planned\n\n\n ROOT, Switzerland--(BUSINESS WIRE)--\nNovocure (NASDAQ: NVCR) today announced the results of a pre-specified interim analysis for the phase 3 PANOVA-3 clinical trial evaluating the safety and efficacy of Tumor Treating Fields (TTFields) therapy together with nab-paclitaxel and gemcitabine for the treatment of patients with unresectable, locally advanced pancreatic cancer. An independent data monitoring committee (DMC) reviewed the safety and efficacy data for all patients in the fully enrolled clinical trial. The interim analysis resulted in a DMC recommendation that the clinical trial proceed to final analysis.\n\n\n“Completion of the interim analysis with the DMC’s recommendation to continue PANOVA-3 to completion marks another important step in pursuit of our mission to treat patients with difficult solid tumors of the abdomen,” said Asaf Danziger, Novocure’s Chief Executive Officer. “I would like to express my thanks to our patients and investigators. We look forward to reviewing the PANOVA-3 data in 2024 and potentially extending the lives of patients diagnosed with deadly locally advanced pancreatic cancer by treating with our novel therapy, Tumor Treating Fields.”\n\n\nAbout PANOVA-3\n\n\nPANOVA-3 is a randomized, open-label clinical trial designed to enroll 556 adult patients with unresectable, locally advanced pancreatic adenocarcinoma. Patients have been randomized to receive either the combination of nab-paclitaxel and gemcitabine concomitant with TTFields therapy tuned to 150 kHz until progression or the combination of nab-paclitaxel and gemcitabine alone. The primary endpoint is overall survival. Secondary endpoints include progression free survival, local progression free survival, objective response rate, one-year survival rate, quality of life, pain-free survival, puncture-free survival, resectability rate, and toxicity. Following enrollment of the final patient in February 2023, patients will be followed for a minimum of 18 months.\n\n\nAbout Pancreatic Cancer\n\n\nPancreatic cancer is one of the most lethal cancers and is the third most frequent cause of death from cancer in the U.S. While overall cancer incidence and death rates are remaining stable or declining, the inci...