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Novocure Limited NVCR announced meeting the primary endpoint of overall survival (OS) in a late-stage study, which evaluated the use of Tumor Treating Fields (TTFields) therapy concomitantly with chemotherapy regimen as a first-line treatment for unresectable, locally advanced pancreatic adenocarcinoma. Shares of the company gained 49% on Monday in response to the encouraging news.
TTFields are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. The phase III PANOVA-3 evaluated the efficacy and safety of TTFields therapy in combination with standard-of-care (SoC) chemotherapy (gemcitabine and nab-paclitaxel) to treat pancreatic cancer patients. The enrolled patient population was randomized equally into two arms to receive either the combo regimen or SoC chemotherapy alone (control) and followed for atleast 18 months.
Pancreatic cancer is one of the deadliest cancers and the third leading cause of cancer-related deaths in the United States. While overall cancer rates remaining stable or declining, pancreatic cancer incidence and mortality are rising, with around 67,000 new cases in the United States annually and a five-year survival rate of only 13%. This represents a significant unmet medical need.
Year to date, shares of Novocure have skyrocketed 99.9% against the industry’s 7% decline.
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NVCR’s TTFields Therapy Shows Significant Survival Benefits
Per the data readout, pancreatic adenocarcinoma patients treated with TTFields therapy concomitant with SoC chemotherapy experienced a median OS of 16.20 months compared with 14.16 months in the control arm, demonstrating a statistically significant 2-month improvement in survival benefit. Consequently, PANOVA-3 became the first and only phase III study to demonstrate a statistically significant OS benefit, specifically in unresectable, locally advanced pancreatic cancer.
Novocure further reported that the survival rate benefit for patients treated with TTFields therapy increased over time, witnessing a 13% improvement in the OS rate at 12 months and a 33% improvement in the survival rate at 24 months. Additionally, the combo therapy was also overall well-tolerated in the study with a safety profile consistent with prior clinical studies.
Detailed results from the phase III PANOVA-3 study will be presented at an upcoming medical conference. Based on the encouraging phase III results, Novocure plans to file regulatory applications seeking the approval of TTFields therapy to treat unresectable, locally advanced pancreatic adenocarcinoma in the United States, the European Union, Japan and other key geographies.