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Novocure Announces Positive Topline Results from Phase 2 PANOVA-4 Clinical Trial of Tumor Treating Fields (TTFields) Therapy for Metastatic Pancreatic Cancer
BAAR, Switzerland--(BUSINESS WIRE)-- Novocure (NASDAQ: NVCR) announced positive results today from the Phase 2 PANOVA-4 trial of Tumor Treating Fields
About this update from Novocure Limited
[{"type":"text","content":" BAAR, Switzerland--(BUSINESS WIRE)--\nNovocure (NASDAQ: NVCR) announced positive results today from the Phase 2 PANOVA-4 trial of Tumor Treating Fields (TTFields) therapy concomitant with atezolizumab (Tecentriq®), gemcitabine and nab-paclitaxel (gem/nab-pac) as a first-line treatment for metastatic pancreatic ductal adenocarcinoma (mPDAC).\n\n\nPANOVA-4 met its pre-specified primary endpoint, achieving a statistically significant improvement in disease control rate (DCR) compared to the DCR reported in the Phase 3 MPACT study used as the historical control.1 The DCR in patients treated with TTFields therapy concomitantly with atezolizumab and gem/nab-pac (N=78) was 74.4% compared to a DCR of 48% in patients receiving gem/nab-pac alone (N=431) in the historical control (difference = 26.4%, 1-sided p-value \n“The positive results from the PANOVA-4 trial further support the potential of Tumor Treating Fields to improve outcomes in pancreatic cancer,” said Uri Weinberg, MD, PhD, Chief Medical and Innovation Officer, Novocure. “We are grateful to the patients, caregivers, and investigators whose dedication made this trial possible, and we look forward to evaluating the full results from PANOVA-4 as we advance Tumor Treating Fields therapy as a treatment for metastatic pancreatic cancer.”\n\n\nIn the PANOVA-4 trial, DCR was defined as the proportion of patients who had either stable disease (SD) for at least 16 weeks or confirmed partial response (PR) or complete response (CR) according to the Response Evaluation Criteria in Solid Tumours (RECIST v1.1).\n\n\nSecondary endpoints in PANOVA-4 include objective response rate (ORR) and overall survival (OS). The ORR in patients treated with TTFields therapy concomitantly with atezolizumab and gem/nab-pac was 34.6% (95% CI, 24.2% - 46.2%) and median OS was 9.7 months (95% CI, 7.9 - 12.7 months). Additional secondary endpoints were progression-free survival, one-year survival rate, progression-free survival at six months, duration of response, and rate of patients with treatment emergent adverse events.\n\n\nMedian TTFields therapy duration was 25.6 weeks and median systemic therapy treatment was six cycles for atezolizumab and gem/nab-pac. TTFields therapy was well-tolerated, and device related safety was consistent with prior clinical studies.\n\n\nNovocure plans to present additional re...