TG Therapeutics Reports Positive Interim Data from UNITY-NHL Phase 2b Trial Evaluating Umbralisib Monotherapy in Patients with Marginal Zone Lymphoma at the 2019 AACR Annual Meeting
Overall response rate (
Responses were durable, with median duration of response (DOR) not reached at median 12.5 months follow-up, and all patients in complete response remain on study
Umbralisib was well tolerated with a safety profile that appeared to be maintained with prolonged exposure
Umbralisib previously granted Breakthrough Therapy Designation for the treatment of patients with relapsed/refractory MZL
Company to host conference call today,
The interim data were reported this morning by Dr.
Summary of Data Presented:
The MZL cohort of UNITY-
Analysis of the interim efficacy population (n=42) with a median follow-up of 12.5 months showed the following:
|Interim Efficacy Population (n=42)|
|Overall Response Rate by IRC (CR + PR), %||52||%|
|Complete Response by IRC (CR), (%)||19||%|
|Partial Response by IRC (PR), (%)||33||%|
|Median duration of response, months||NR (95% CI: 8.4 – NE)|
CI = confidence interval; NR = not reached; NE = not estimable; SD = stable disease
Additional Efficacy Highlights:
- 88% clinical benefit rate by IRC (defined as patients obtaining Complete Response + Partial Response + Stable Disease)
- All patients achieving a Complete Response by IRC remain on study (range: 10.1+ to 15.7+ months)
- 86% of patients had a reduction in tumor burden
- Median time to initial response was 2.7 months
- Kaplan-Meier (KM) estimate of progression-free survival (PFS) at 12 months was 66%, with the median PFS not reached
Interim safety data were presented for all 69 treated patients with a median duration of exposure of 6.9 months. No unexpected toxicities were observed. The most common adverse events were diarrhea, nausea, and fatigue, with the majority of events Grade 1 in severity. The most frequent grade 3 or higher adverse events were neutropenia, diarrhea and ALT/AST increase, observed in 13%, 10% and 10% of patients, respectively.
A subgroup analysis of patients treated for greater than 6 cycles (n=41) was also conducted to evaluate long-term incidence of key toxicities of interest occurring after 6 cycles of treatment. Median duration of treatment of this subgroup was 10.1 months (range: 5.6 – 19.1 months). In this subgroup, grade 3 or higher adverse events of interest were rare, limited to 2 patients with diarrhea and 1 patient with pneumonitis, with no events of ALT/AST elevation, pneumonia, or colitis.
Key Safety Findings (n=69):
- No events of colitis were reported and only 1 event of Grade 3 pneumonitis was reported
- Grade 3 infections were limited, occurring in 3 patients (bronchitis, pneumonia, and influenza)
- Discontinuations due to umbralisib-related AEs were limited (14%) with no discontinuations after 6 months due to a treatment-related AE
- No deaths occurred on study
CONFERENCE CALL INFORMATION
The Company will host a conference call today, Monday April 1, 2019, at
In order to participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics AACR Update Call.
A live webcast and accompanying slides will be available on the Events page, located within the Investors & Media section, of the Company's website at http://ir.tgtherapeutics.com/events. An audio recording of the conference call will also be available for replay at www.tgtherapeutics.com for a period of 30 days after the call.
2019 AACR ORAL PRESENTATION DETAILS
- Title: Umbralisib monotherapy demonstrates efficacy and safety in patients with relapsed/refractory marginal zone lymphoma: A multicenter, open-label, registration directed Phase II study
- Session Date and Time:
Monday April 1, 2019 3:00 PM - 5:00 PM ET
- Presentation Time:
4:20 PM ET
- Session Title: The Next Generation of Clinical Trials in Molecularly-driven Therapy
- Session Location:
Marcus Auditorium- Bldg A-GWCC
- Presenter: Nathan Fowler, MD, Associate Professor,
Department of Lymphoma/Myeloma, The University of Texas MD Anderson Cancer Center, Houston, TX
- Abstract Number: 7821
- Session Date and Time:
The full text of the abstract is now available and can be accessed via the AACR meeting website at www.aacr.org. The slides to be presented in this afternoon’s oral presentation are available on the Company’s corporate website at www.tgtherapeutics.com/publications.cfm.
ABOUT THE UNITY-NHL PHASE 2b STUDY—Marginal Zone Lymphoma Cohort
The multicenter, open-label, UNITY-NHL Phase 2b study - Marginal Zone Lymphoma cohort was designed to evaluate the safety and efficacy of single agent umbralisib, in patients with MZL who have received at least one prior anti-CD20 regimen. The primary endpoint is overall response rate (
The MZL cohort completed enrollment in
ABOUT BREAKTHROUGH THERAPY DESIGNATION
The Company announced in January of 2019 that the
The FDA’s Breakthrough Therapy designation is intended to expedite the development and review of a drug candidate that is planned to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on one or more clinically significant endpoints over available therapies.
TG Therapeutics is a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. Currently, the company is developing multiple therapies targeting hematological malignancies and autoimmune diseases. Ublituximab (TG-1101) is a novel, glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. TG Therapeutics is also developing umbralisib (TGR-1202), an oral, once-daily inhibitor of PI3K-delta. Umbralisib uniquely inhibits CK1-epsilon, which may allow it to overcome certain tolerability issues associated with first generation PI3K-delta inhibitors. Both ublituximab and umbralisib, or the combination of which is referred to as "U2", are in Phase 3 clinical development for patients with hematologic malignancies, with ublituximab also in Phase 3 clinical development for Multiple Sclerosis. Additionally, the Company has recently brought into Phase 1 clinical development, TG-1501, its anti-PD-L1 monoclonal antibody, TG-1701, its covalently-bound Bruton’s Tyrosine Kinase (BTK) inhibitor and TG-1801, its anti-CD47/CD19 bispecific antibody. TG Therapeutics is headquartered in New York City.
Some of the statements included in this press release 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. In addition to the risk factors identified from time to time in our reports filed with the Securities and Exchange Commission, factors that could cause our actual results to differ materially are the following: the risk that the interim data (the “Interim Results”) from the UNITY-NHL MZL cohort released today will not be reproduced when the final analysis is conducted on all patients later this year, including the risk that the final results will demonstrate a lower
Senior Vice President,
Source: TG Therapeutics, Inc.