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Findings from Phase II JULIET Study
Findings from Phase II JULIET Study.
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[{"type":"text","content":"\n \nRNS Number : 1002I Oxford Biomedica PLC 14 June 2017 \n\n \n \n \n \n \n \nOxford BioMedica Notes Findings on CTL019 from Phase II JULIET Study Presented at the 14th Meeting of International Conference on Malignant Lymphoma (ICML)\n \nOxford, UK - 14 June 2017: Oxford BioMedica plc (\"Oxford BioMedica\" or \"the Group\") (LSE:OXB), a leading gene and cell therapy group, today notes the findings reported by Novartis on its global multi-centre Phase II JULIET study evaluating the efficacy and safety of CTL019 (tisagenlecleucel-T), an investigational chimeric antigen receptor T cell (CAR-T) therapy, in adult patients with relapsed and refractory (r/r) diffuse large B-cell lymphoma (DLBCL). The study met its primary objective at interim analysis. \nOxford BioMedica is the sole manufacturer of the lentiviral vector expressing CTL019 for Novartis. The commercial launch of CTL019 is anticipated by Novartis later this year and Oxford BioMedica will receive undisclosed royalties on potential future sales of Novartis CAR-T products.\nThe findings were presented during an oral session at 15:40 CET on Wednesday 14th June 2017 at the 14th International Conference on Malignant Lymphoma (ICML) meeting (Abstract #007).\n \nNovartis reported the interim analysis of the global multi-centre Phase II JULIET study which showed a 3-month Overall Response Rate (ORR) of 45% (23 of the 51 patients evaluated), with 37% achieving a Complete Response (CR) and 8% achieving a Partial Response (PR), respectively. CR remained stable from three months through data cut off among the patient group. Among 51 patients with >3 month follow-up or earlier discontinuation, best ORR was 59% (95% CI, 44%-72%; P<0.0001) with 43% achieving CR and achieving 16% PR. CR and PR rates at 3 months were 37% and 8% respectively. Cytokine Release Syndrome (CRS) occurred in 57% of infused patients (17% grade 3, 9% grade 4); no CRS associated deaths occurred. No cerebral oedema was reported. Three patients died from disease progression, within 30 days of infusion. No deaths were attributed to CTL019. The abstract is available online here: http://onlinelibrary.wiley.com/doi/10.1002/hon.2437_6/full.\n \nThe overall response rate seen in this early analysis is impressive for these heavily pre-treated patients with ...