Moskowitz CH et al. Proc ASH 2015;Abstract 182.

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Moskowitz CH et al. Proc ASH 2015;Abstract 182. A Phase 1 Study of Denintuzumab Mafodotin (SGN-CD19A) in Relapsed/Refractory B-Lineage Non-Hodgkin Lymphoma Moskowitz CH et al. Proc ASH 2015;Abstract 182.

SGN19A-002 Trial: Denintuzumab Mafodotin (DM), a Novel Antibody-Drug Conjugate, in B-Lineage Non-Hodgkin Lymphoma Phase I, open-label, dose-escalation study of DM, an anti‑CD19 monoclonal antibody conjugated to monomethyl auristatin F N = 62 patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL, n = 54 including 16 with transformed DLBCL), mantle-cell lymphoma (n = 5) and Grade III follicular lymphoma (n = 3) Primary endpoints: Incidence of adverse events and laboratory abnormalities Endpoint Relapsed Refractory Overall response rate (ORR) (n = 25, 35) 60% 23% Complete response (CR) (n = 25, 35) 40% 11% Duration of response (n = 25, 35) 47.1 wk 41.1 wk Median progression-free survival (n = 25, 37) 25.1 wk 6.1 wk Median overall survival (n = 25, 37) 56.7 wk 29 wk Moskowitz CH et al. Proc ASH 2015;Abstract 182; www.clinicaltrials.gov (NCT01786135).

SGN19A-002: Adverse Events (>15% of Patients) 63 53 39 39 39 27 Grade 1 and 2 Grade 3 Grade 4 27 26 23 21 19 16 16 Percentage of patients with treatment-emergent adverse events Moskowitz CH et al. Proc ASH 2015;Abstract 182.

SGN19A-002: Conclusions DM demonstrated encouraging antitumor activity in patients with heavily pretreated DLBCL: ORR 60%, CR 40% among patients with relapsed disease DM is generally well tolerated with low rates of myelosuppression and peripheral neuropathy: Mild to moderate ocular symptoms secondary to keratopathy improved/resolved in the majority of patients Maximum tolerated dose not exceeded at 6 mg/kg DM may be incorporated into novel combination regimens. A randomized Phase II study is evaluating R-ICE with or without DM as second-line treatment for transplant-eligible patients with DLBCL (NCT02592876). Moskowitz CH et al. Proc ASH 2015;Abstract 182.

Investigator Commentary: Results of a Phase I Study of DM in Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma Craig Moskowitz and colleagues presented data with SGN-CD19A (DM) in relapsed/refractory B-cell non-Hodgkin lymphoma. DM is an antibody-drug conjugate in which an anti-CD19 monoclonal antibody is conjugated to the microtubule inhibitor monomethyl auristatin F. Of the 62 patients who received treatment, 87% had DLBCL, 8% had mantle-cell lymphoma and 5% had Grade III follicular lymphoma. For 60% of patients the disease was refractory to their most recent therapy. The ORR was 60% with a CR rate of 40% for patients with relapsed disease and 23% with a CR rate of 11% for patients with refractory disease. The median duration of response ranged from 41.1 to 47.1 weeks, dependent on relapsed versus refractory disease status. A unique adverse event was keratopathy, reported in 39% of patients with superficial microcystic keratopathy reported in 84%. Keratopathy was managed with steroids and improved or resolved at a median of 5 weeks. A randomized Phase II trial of R-ICE with or without DM is under way for patients with relapsed/refractory DLBCL before autologous stem cell transplant (NCT02592876). Interview with Michelle A Fanale, MD, February 18, 2016