TG Therapeutics Announces the Triple Combination of TG-1101, TGR-1202 and Ibrutinib is Safe and Highly Active in Patients With Advanced B-Cell Malignancies
Jun 01, 2015
Data presented this morning by Dr.
Minimal adverse events reported to date with Grade 3 or 4 events seen in 6% of patients, with no patients discontinuing treatment due to an adverse event up through 800 mg micronized TGR-1202 and patients remaining on treatment now up to 9.5+ months
100% (4/4) ORR in patients with CLL/SLL with all CLL patients having high-risk features (17p del) and 75% ORR in iNHL (FL/MZL) with one ibrutinib refractory Follicular Lymphoma patient achieving a durable Partial Response
All responses were rapid and profound with a 76% median reduction in disease burden at first efficacy assessment, with all patients who had a subsequent efficacy assessment achieving a deeper response with a median 92% reduction
The following summarizes the oral presentation:
Abstract Number 8501: Safety and activity of the chemotherapy-free triplet of ublituximab, TGR-1202, and ibrutinib in relapsed B-cell malignancies
Today's oral presentation includes data from 16 patients with advanced relapsed and refractory high-risk CLL and
Safety and Tolerability
TG-1101 in combination with TGR-1202 and ibrutinib has been well tolerated in the 16 patients evaluable for safety, at dose levels up through 800 mg micronized, the highest dose level tested to date in the study. Three cohorts for each CLL and
Clinical activity was observed at all 3 dose levels with 13 of 16 patients evaluable for efficacy (1 patient was removed per investigator discretion and 2 were too early to evaluate). The following is a highlight of responses by CLL and
- In the CLL/SLL cohort, 100% of patients (4 of 4) achieved an objective response at the first efficacy assessment, with all CLL patients having 17p deletion. All 4 responding patients remain on study now up to 7+ months.
In patients with heavily pre-treated (≥ 4 prior lines of therapy) Follicular or
Marginal Zonelymphoma 75% (3 of 4) achieved an objective response including one ibrutinib refractory patient achieving a PR at the first efficacy assessment. The one patient who achieved stable disease (achieved a 39% nodal reduction) was duvelisib refractory. All FL and MZL patients remain on study awaiting further assessments, now up through 9.5+ months.
- Both Mantle Cell lymphoma (MCL) patients achieved an objective response with 1 patient who had previously relapsed after an autologous stem cell transplant subsequently achieving a complete response. As with the other responding patients, both MCL patients remain on study now through 9.5+ months.
Of the 3 patients who progressed on study, 1 patient was a Richter's Transformation and 2 were Diffuse Large B-Cell who were both of
Of importance, patients who responded to the triple combination at their first efficacy assessment (week 8) and were evaluable for a second efficacy assessment (week 20), had an improved response. All responses were rapid and profound with a 76% median reduction in disease burden at the first efficacy assessment, with all patients who had a second response assessment achieving a deeper response with a median 92% reduction.
Commenting on the triple combination data, Dr. Nathan Fowler stated: "Combining multiple targeted agent drugs has long been a goal for investigators but has proved to be a challenge as evidenced by recent studies combining
Some of the statements included in this press release, particularly those with respect to anticipating future clinical trials, the timing of commencing or completing such trials and business prospects for TG-1101, TGR-1202, the IRAK4 inhibitor program, and the anti-PD-L1 and anti-GITR antibodies 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, TGR-1202, the IRAK4 inhibitor program and the anti-PD-L1 and anti-GITR antibodies; the risk that early pre-clinical and clinical results that supported our
decision to move forward with TG-1101, TGR-1202, the IRAK4 inhibitor program and the anti-PD-L1 and anti-GITR antibodies will not be reproduced in additional patients or in future studies; the risk that trends observed which underlie certain assumptions of future performance of TGR-1202 will not continue, the risk that TGR-1202 will not produce satisfactory safety and efficacy results to warrant further development following the completion of the current Phase 1 study; 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, particularly with respect to the incidence of colitis and liver toxicity; the risk that trials will take longer to enroll than expected; 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
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Jenna BoscoDirector- Investor Relations TG Therapeutics, Inc.Telephone: 212.554.4351 Email: email@example.com
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