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Zai Lab and Novocure Announce Positive Topline Results from Phase 3 PANOVA-3 Clinical Trial of Tumor Treating Fields (TTFields) Therapy for Pancreatic Cancer
PANOVA-3 met its primary endpoint with a statistically significant improvement in overall survival for patients with unresectable, locally advanced
About this update from Novocure Limited
[{"type":"text","content":"\nPANOVA-3 met its primary endpoint with a statistically significant improvement in overall survival for patients with unresectable, locally advanced pancreatic adenocarcinoma treated in the first-line with TTFields concomitant with gemcitabine and nab-paclitaxel\n\n\nNovocure plans to file for regulatory approval in the U.S., EU, Japan and other key markets; Zai Lab plans to file for regulatory approval in China\n\n\nFull results from the PANOVA-3 trial will be presented at an upcoming medical congress\n\n\n SHANGHAI & CAMBRIDGE, Mass. & ROOT, Switzerland--(BUSINESS WIRE)--\nZai Lab Limited (Nasdaq: ZLAB; HKEX: 9688) and Novocure (NASDAQ: NVCR) announced today that the pivotal, Phase 3 PANOVA-3 trial met its primary endpoint, demonstrating a statistically significant improvement in median overall survival (mOS) versus control. PANOVA-3 evaluated the use of Tumor Treating Fields (TTFields) therapy concomitantly with gemcitabine and nab-paclitaxel as a first-line treatment for unresectable, locally advanced pancreatic adenocarcinoma.\n\n\n“As a researcher and clinician, I have experienced the challenges of developing treatments in pancreatic cancer. It is exciting to see the PANOVA-3 trial achieve the positive primary endpoint of overall survival, a landmark outcome for this field,” said Vincent Picozzi, M.D., medical oncologist and investigator in the PANOVA-3 trial. “These data for Tumor Treating Fields are very promising, especially in this difficult to treat patient population.”\n\n\nIn the intent-to-treat population, patients treated with TTFields therapy concomitant with gemcitabine and nab-paclitaxel had an mOS of 16.20 months compared to 14.16 months in patients treated with gemcitabine and nab-paclitaxel alone, a statistically significant 2.0-month improvement (hazard ratio=0.819; P=0.039) (N=571). The survival rate benefit for patients treated with TTFields therapy increased over time with a 13% improvement in the overall survival rate at 12 months and a 33% improvement in survival rate at 24 months. TTFields therapy was well-tolerated, and safety was consistent with prior clinical studies.\n\n\n“PANOVA-3 is the first and only Phase 3 trial to demonstrate a statistically significant benefit in overall survival specifically in unresectable, locally advanced pancreatic cancer, and is Novocure’s third positive Phase 3 clin...