Program: Oral and Poster Abstracts
Session: 624. Lymphoma: Therapy with Biologic Agents, excluding Pre-Clinical Models: Poster III
Methods: Eligible patients had rel/ref MCL with an ECOG PS < 3. Prior ibrutinib treatment was permitted. UTX (900 mg) was administered on Days 1, 8, and 15 in Cycle 1 followed by Day 1 of Cycles 2 - 6. Ibrutinib was started on Day 1 and continued daily at 560 mg. Following Cycle 6, patients came off study but could remain on ibrutinib. Primary endpoints were safety and ORR with an emphasis on early activity with response assessments by CT scan scheduled prior to cycles 3 and 6 only (criteria per Cheson 2007).
Results: 15 patients were enrolled: 13 M/2 F, median age 71 yr (range 55-80), ECOG 0/1: 9/6, median prior Tx = 3 (range 1-8), 53% with ≥ 2 prior anti-CD20 therapies, 40% prior bortezomib. Gr 3/4 AE’s occurring in at least 5% of patients and at least possibly related to UTX and/or ibrutinib included: neutropenia (13%), fatigue (7%), rash (7%) and atrial fibrillation (7%). Ibrutinib was dose reduced due to an AE in 1 patient (rash) and discontinued in 1 patient due to atrial fibrillation. No UTX dose reductions occurred. All 15 pts are evaluable for response with best response to treatment as follows: 87% (13/15) ORR with 33% (5/15) Complete Response. Three of the CR’s occurred at week 8. Of the two patients not achieving an objective response, one patient was stable at first scan and came off treatment prior to second efficacy assessment (ibrutinib related A-Fib) and one patient progressed at first assessment. Responses generally improved from first to second assessment with median tumor reduction of 64% by week 8 and 82% by week 20.
Conclusions: Ublituximab, a glycoengineered anti-CD20 mAb, in combination with ibrutinib is both well-tolerated and highly active in pts with rel/ref MCL. Response rate, depth of response, and time to response compare favorably to historical data with ibrutinib alone. A randomized phase 3 trial with ibrutinib +/- ublituximab is currently ongoing in high-risk CLL pts and future studies using this combination in MCL are being evaluated.
Disclosures: Kolibaba: Janssen: Research Funding ; Novartis: Research Funding ; Pharmacyclics: Research Funding ; Seattle Genetics: Research Funding ; Gilead: Consultancy , Honoraria , Research Funding ; TG Therapeutics: Research Funding ; GSK: Research Funding ; Genentech: Research Funding ; Cell Therapeutics: Research Funding ; Celgene: Research Funding ; Amgen: Research Funding ; Amgen: Research Funding ; Acerta: Research Funding . Burke: Gilead: Consultancy ; Millenium/Takeda: Consultancy ; Seattle Genetics, Inc.: Research Funding ; Incyte: Consultancy ; Janssen: Consultancy ; TG Therapeutics: Other: Travel expenses . Farber: TG Therapeutics, Inc.: Research Funding . Fanning: Celgene and Millennium/Takeda: Speakers Bureau . Schreeder: TG Therapeutics, Inc: Research Funding . Boccia: Incyte Corporation: Honoraria . Sportelli: TG Therapeutics, Inc.: Employment , Equity Ownership . Miskin: TG Therapeutics, Inc.: Employment , Equity Ownership . Weiss: TG Therapeutics, Inc.: Employment , Equity Ownership . Sharman: Roche: Research Funding ; Gilead: Consultancy , Honoraria , Research Funding , Speakers Bureau ; Pharmacyclics: Consultancy , Honoraria , Research Funding ; Calistoga: Honoraria ; Janssen: Research Funding ; TG Therapeutics, Inc.: Research Funding ; Celgene Corporation: Consultancy , Research Funding .
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