Full Press Release Details
TG Therapeutics Announces Positive Outcome from UNITY-NHL Phase 2b
Pivotal Trial Evaluating Umbralisib in Patients with
Relapsed/Refractory Marginal Zone Lymphoma
Study met the primary endpoint of Overall Response Rate
Interim data to be presented in an oral presentation at the 2019
American Association of Cancer Research (AACR) annual meeting on
Umbralisib was previously granted Breakthrough Therapy Designation
based on interim data from the marginal zone lymphoma (MZL) cohort
of the UNITY-NHL trial
Conference call to be held today, Thursday February 28, 2019 at
YORK, NY, February 28, 2019 (GLOBE NEWSWIRE)
TG Therapeutics, Inc. (NASDAQ: TGTX), a
biopharmaceutical company developing medicines for patients with
B-cell mediated diseases, today announced that the Marginal Zone
Lymphoma (MZL) cohort of the UNITY-NHL Phase 2b pivotal trial
evaluating umbralisib (TGR-1202), our novel, once daily, PI3K delta
inhibitor, met the primary endpoint of Overall Response Rate (ORR)
as determined by Independent Review Committee (IRC) for all treated
patients (n=69). The results met the Company's target
guidance of 40-50% ORR.
safety and efficacy data from this study will be presented in an
oral presentation at the upcoming American Association of Cancer
Research (AACR) annual meeting on April 1, 2019 and full data from
this study are expected to be presented at a medical meeting later
this year. The company plans to discuss the results with the U.S.
Food and Drug Administration (FDA) regarding a potential new
drug application (NDA) filing for accelerated approval. Umbralisib
was recently granted Breakthrough Therapy Designation (BTD) by the
FDA for the treatment of adult patients with MZL who have received
at least one prior anti-CD20 regimen.
S. Weiss, Executive Chairman and Chief Executive Officer of TG
Therapeutics stated, We are extremely pleased to announce
that the UNITY-NHL marginal zone lymphoma cohort evaluating
umbralisib monotherapy met the primary endpoint of ORR. While this
was an early look at the response data, we were excited to have
already met the target ORR, which we previously stated was
approximately 40%-50%. Importantly, with many patients still on
study, we anticipate the ORR will continue to improve with
additional follow-up, which will also provide us with critical
information on duration of response, progression free survival and
long-term safety and tolerability necessary to support an NDA
Weiss continued, There are no fully approved drugs for MZL,
and thus remains an unmet medical need and we are excited by the
potential to offer a novel treatment for this underserved
population. We look forward to discussing the results with the FDA
as soon as possible and if all goes well, we believe we could be in
a position to file for accelerated approval for umbralisib by
About the UNITY-NHL Phase 2b Study Marginal Zone Lymphoma
multicenter, open-label, UNITY-NHL Phase 2b study - Marginal Zone
Lymphoma cohort was designed to evaluate the safety and efficacy
of single agent umbralisib, the Company's novel, once
daily, PI3K delta inhibitor, in patients with MZL who have received
at least one prior anti-CD20 regimen. The primary endpoint is
overall response rate (ORR) as determined by Independent Review
Committee (IRC) assessment. The primary analysis of ORR will be
conducted once all treated patients have had at least 9 cycles
(Cycle = 28 days) of follow-up. Secondary endpoints include safety,
duration of response, and progression-free survival
cohort completed enrollment in August 2018 with a total of 69
patients enrolled and receiving at least one dose of umbralisib.
The positive ORR outcome announced today was based on all 69
enrolled and treated patients, however at this time all patients
have not yet been followed for a minimum of 9 cycles as required
for the primary analysis of ORR. Accordingly, the study is on-going
and patients with benefit on therapy (stable disease or in
response) remain on study. Safety data are currently being
AACR Oral Presentation Details
titles are now available online and can be accessed on the AACR
meeting website at www.aacr.org. The complete text of the abstract
will be available on the meeting website on Friday, March 29, 2019.
The presentation is expected to include a subset of patients from
the UNITY-NHL-Marginal Zone Cohort with long-term follow-up as of
the data cut-off. Additional details regarding the presentation are
Title: Umbralisib monotherapy demonstrates efficacy and
safety in patients with relapsed/refractory marginal zone lymphoma:
A multicenter, open-label, registration directed Phase II
Time: Monday April 1, 2019
3:00 PM - 5:00 PM ET
Title: The Next Generation
of Clinical Trials in Molecularly-driven Therapy
Auditorium- Bldg A-GWCC
Presenter: Nathan Fowler, MD, Associate Professor, Department
of Lymphoma/Myeloma, The University of Texas MD Anderson Cancer
the presentation, the data presented will be available on the
Publications page, located within the Pipeline section, of the
Company's website at www.tgtherapeutics.com/publications.cfm.
CONFERENCE CALL INFORMATION
Company will host a conference call today, Thursday, February
28, 2019 at 8:30 AM ET to discuss the UNITY-NHL MZL
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 Update Call.
webcast of this presentation will be available on the Events page,
located within the Investors & Media section, of the Company's
website at www.tgtherapeutics.com.
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.
ABOUT MARGINAL ZONE LYMPHOMA
Marginal zone lymphoma (MZL) comprises a group of