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Interim analysis of a phase 1, open-label, dose-escalation study of SGN-CD19A in patients with relapsed or refractory B-lineage non-Hodgkin lymphoma (NHL).
J Clin Oncol 32:5s, 2014 (suppl; abstr 8505)
Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy are designated with a caret symbol (^).
Background: CD19, a member of the immunoglobulin superfamily, is expressed in most patients with B-cell NHL. SGN-CD19A is a novel antibody-drug conjugate composed of a humanized anti-CD19 monoclonal antibody conjugated to the microtubule-disrupting agent monomethyl auristatin F (MMAF) via a maleimidocaproyl linker. Methods: This phase 1, open-label, dose-escalation study investigates the safety, tolerability, pharmacokinetics (PK), and antitumor activity of SGN-CD19A in patients with relapsed or refractory B-cell NHL with at least 1 prior systemic regimen (NCT01786135). Patients with DLBCL or follicular lymphoma grade 3 (FL3) must have received intensive salvage therapy. A modified continual reassessment method is used for dose allocation and maximum tolerated dose (MTD) estimation. SGN-CD19A is given by IV on Day 1 of 21-day cycles. Results: To date, 22 patients with a median age of 63 years (range, 33 to 81) with DLBCL (18), MCL (3), and FL3 (1) have been treated with SGN-CD19A. 50% of patients were refractory to their last treatment; 6 patients received prior autologous SCT. Patients have received a median of 2 cycles (range, 1 to 9) at dose levels from 0.5 mg/kg to 6 mg/kg. 11 patients remain on treatment and 11 have discontinued due to progressive disease (10) and patient decision (1). No dose-limiting toxicity (DLT) has been reported in 21 DLT-evaluable patients; the MTD has not yet been identified. Adverse events occurring in ≥10% of patients are fatigue (27%), blurred vision (27%), dry eye (23%), constipation (23%), dyspnea (14%), and keratitis (14%). Of the 20 patients evaluated, objective responses were observed in 8 patients (40%), 6 CRs (30%) and 2 PRs (10%); 3 patients had SD (15%) and 9 had PD (45%). SGN-CD19A ADC plasma exposures were approximately dose-proportional in preliminary PK analysis with mean terminal half-lives between 9-30 days. Conclusions: To date, SGN-CD19A has shown evidence of clinical activity with an objective response rate of 40% (8 of 20 patients) and an observed CR rate of 30% (6 of 20 patients). No DLTs have been reported in tested dose levels; enrollment is ongoing to identify the optimal dose of SGN-CD19A for future studies. Clinical trial information: NCT01786135.
Abstracts by Andres Forero-Torres:
TBCRC030: A randomized, phase II study of preoperative cisplatin versus paclitaxel in patients (pts) with BRCA1/2-proficient triple-negative breast cancer (TNBC)—Evaluating the homologous recombination deficiency (HRD) biomarker.
Whole-exome sequencing (WES) of HER2+ metastatic breast cancer (MBC) from patients (pts) treated with prior trastuzumab (T): A correlative analysis of TBCRC003.Category: Breast Cancer - HER2/ER - HER2+
Presentations by Andres Forero-Torres:
Meeting: 2010 Breast Cancer Symposium
Abstract No: 161
Session: General Session IX: Triple-negative Breast Cancer: Clinical Science Symposium (General Session)
Meeting: 2009 ASCO Annual Meeting
Session: Cross Talk between the Estrogen Receptor and Other Targets: Improving Endocrine Responsiveness (Education Session)