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TG Therapeutics, Inc. Announces Presentation of Interim Results From Its Phase I/II Clinical Trial of Single-Agent Ublituximab (TG-1101) in Patients With Rituximab Relapsed/Refractory Non-Hodgkin's Lymphoma
Jun 03, 2013
TG-1101 Well Tolerated and Induced 50% Overall Response Rate (5/10)
40% of Rituximab-Refractory Patients (2/5) Achieve a Complete Response
100% of Marginal Zone Lymphoma Patients (3/3) Achieve a Complete or Partial Response
PRELIMINARY DATA FROM THE DOSE ESCALATION PORTION OF PHASE I/II STUDY
The poster presentation highlighted preliminary safety and efficacy data from 4 cohorts of 3 patients each at dose levels of 450mg, 600mg, 900mg and 1200mg. All 12 patients (7 Follicular (FL), 3
Ublituximab (TG-1101) was well tolerated with the majority of adverse events being Grade 1 and 2, with minimal Infusion Related Reactions (IRR) observed. Only one Grade 3 event was reported. All 12 patients completed all planned infusions. Infusion time decreased significantly from the first (mean of 4 hours) to the fourth and maintenance infusions (mean of ~ 1.5 hours).
The summary of response data is described below:
Lymphoma Type | N | CR | PR | SD | PD | TETE | CR % | ORR % |
Follicular (FL) | 7 | 1 | 1 | 3 | 1 | 1 | 17% | 33% |
|
3 | 2 | 1 | 67% | 100% | |||
Mantle Cell (MCL) | 2 | 1 | 1 | |||||
Total | 12 | 3 | 2 | 3 | 2 | 2 | 30% | 50% |
Abbreviations: Complete Response (CR); Partial Response (PR); Stable Disease (SD); Progressive Disease (PD); Overall Response Rate (ORR);
Median Progression-Free Survival (PFS) has not been reached. Responses were observed in both rituximab relapsed and refractory patients, including patients who have seen several lines of rituximab therapy. Of the 5 patients enrolled that were refractory to rituximab, 2 patients (40%) achieved a CR. Decreases in overall tumor volume were seen in 9/10 of the evaluable patients. Notably, 100% (3/3) of patients with Marginal Zone Lymphoma responded to ublituximab (TG-1101) therapy, two of which achieved a CR. Among the 5 responding patients, all achieved a response that was better than (n=4) or equal to (n=1) their prior rituximab-based treatment:
Dose | Diagnosis |
Prior RTX Therapies |
RTX Status |
RTX Response |
Ublituximab Response |
Months on Study |
450 | MZL | 3 | Refractory | PD | CR | 10+ |
600 | MZL | 2 | Relapsed | PR | CR | 7+ |
900 | MZL | 1 | Relapsed | SD | PR | 5+ |
900 | FL | 1 | Relapsed | PR | PR | 6+ |
900 | FL | 3 | Refractory | PD | CR | 4+ |
+ Patients still on study with continuing response
Commenting on the Phase I data, Dr.
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Cautionary Statement
Some of the statements included in this press release, particularly those anticipating future clinical trials and business prospects for TG-1101 and TGR-1202 may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: our ability to successfully and cost-effectively complete pre-clinical and clinical trials for TG-1101 and TGR-1202; the risk that early clinical results that supported our decision to move forward into expansion cohorts will not be reproduced once additional patients are treated with TG-1101; the risk that the data (both safety and efficacy) from future clinical trials will not coincide with the
data produced from prior pre-clinical and clinical trials; our ability to achieve the milestones we project over the next year; our ability to manage our cash in line with our projections, and other risk factors identified from time to time in our reports filed with the
TGTX - G
CONTACT:Source:Jenna Bosco Director- Investor RelationsTG Therapeutics, Inc. Telephone: 212.554.4484 Email: ir@tgtxinc.com
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