title: A phase 1/2 trial of ublituximab, a novel anti-CD20 monoclonal antibody, in patients with B-cell non-Hodgkin lymphoma or chronic lymphocytic leukaemia previously exposed to rituximab.
abstract: This phase 1/2 study evaluated the safety, pharmacokinetic behavior and anti-tumour activity of ublituximab, a unique type I, chimeric, glycoengineered anti-CD20 monoclonal antibody, in rituximab-relapsed or -refractory patients with B-cell non-Hodgkin lymphoma (B-NHL) or chronic lymphocytic leukaemia (CLL). Induction therapy (doses of 450-1200 mg) consisted of 4 weekly infusions in cycle 1 for NHL and 3 weekly infusions in cycles 1 and 2 for CLL. Patients received ublituximab maintenance monthly during cycles 3-5, then once every 3 months for up to 2 years. Enrolled patients with B-NHL (n = 27) and CLL (n = 8) had a median of 3 prior therapies. No dose-limiting toxicities or unexpected adverse events (AEs) occurred. The most common AEs were infusion-related reactions (40%; grade 3/4, 0%); fatigue (37%; grade 3/4, 3%); pyrexia (29%; grade 3/4, 0%); and diarrhoea (26%; grade 3/4, 0%). Common haematological AEs were neutropenia (14%; grade 3/4, 14%) and anaemia (11%; grade 3/4, 6%). The overall response rate for evaluable patients (n = 31) was 45% (13% complete responses, 32% partial responses). Median duration of response and progression-free survival were 9·2 months and 7·7 months, respectively. Ublituximab was well-tolerated and efficacious in a heterogeneous and highly rituximab-pre-treated patient population.
authors.affiliation: Center for Lymphoid Malignancies, Columbia University Medical Center, New York, NY, USA.
authors.forename: Ahmed
authors.initials: A
authors.lastname: Sawas
authors.affiliation: Carol G. Simon Cancer Center, Morristown, NJ, USA.
authors.forename: Charles M
authors.initials: CM
authors.lastname: Farber
authors.affiliation: Clearview Cancer Institute, Huntsville, AL, USA.
authors.forename: Marshall T
authors.initials: MT
authors.lastname: Schreeder
authors.affiliation: St. Bernards Clopton Clinic, Jonesboro, AR, USA.
authors.forename: Mazen Y
authors.initials: MY
authors.lastname: Khalil
authors.affiliation: The West Clinic, Memphis, TN, USA.
authors.forename: Daruka
authors.initials: D
authors.lastname: Mahadevan
authors.affiliation: Center for Lymphoid Malignancies, Columbia University Medical Center, New York, NY, USA.
authors.forename: Changchun
authors.initials: C
authors.lastname: Deng
authors.affiliation: Center for Lymphoid Malignancies, Columbia University Medical Center, New York, NY, USA.
authors.forename: Jennifer E
authors.initials: JE
authors.lastname: Amengual
authors.affiliation: University Cancer and Blood Center, Athens, GA, USA.
authors.forename: Petros G
authors.initials: PG
authors.lastname: Nikolinakos
authors.affiliation: Carbone Comprehensive Cancer Center, University of Wisconsin, Madison, WI, USA.
authors.forename: Jill M
authors.initials: JM
authors.lastname: Kolesar
authors.affiliation: University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.
authors.forename: John G
authors.initials: JG
authors.lastname: Kuhn
authors.affiliation: TG Therapeutics Inc., New York, NY, USA.
authors.forename: Peter
authors.initials: P
authors.lastname: Sportelli
authors.affiliation: TG Therapeutics Inc., New York, NY, USA.
authors.forename: Hari P
authors.initials: HP
authors.lastname: Miskin
authors.affiliation: Center for Lymphoid Malignancies, Columbia University Medical Center, New York, NY, USA.
authors.forename: Owen A
authors.initials: OA
authors.lastname: O'Connor
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000009:adverse effects* / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D015451:Leukemia, Lymphocytic, Chronic, B-Cell / Q000188:drug therapy*; D016403:Lymphoma, Large B-Cell, Diffuse / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D000069283:Rituximab / Q000627:therapeutic use*
chemical_list: D000911:Antibodies, Monoclonal; D000970:Antineoplastic Agents; D000069283:Rituximab; C000619007:ublituximab
keywords: B-cell lymphoma; LFB-R603; TG-1101; anti-CD20 monoclonal antibody; ublituximab