Oxford, 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.
Oxford 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.
The 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).
Novartis 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.
The overall response rate seen in this early analysis is impressive for these heavily pre-treated patients with relapsed/refractory DLBCL, who have limited treatment options. The full JULIET primary analysis is expected to be available later this year and will serve as the basis for US and EU regulatory submissions.
John Dawson, Chief Executive Officer of Oxford BioMedica, commented: “We are pleased that Novartis has reported these additional strong data with CTL019 in another indication, r/r DLBCL, which is a much larger target patient population than for r/r ALL. We continue to work closely with Novartis in delivering the lentiviral vector across their CTL019 franchise, a product group described earlier this year, by Novartis, as having “blockbuster” potential.”