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 (ORR) of 52% (N=

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 (ORR) of 52%

(N=42), with complete response (CR) rate of 19%, by central

independent review committee (IRC)

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, April 1, 2019 at 12:00pm

(noon) ET, with Dr. Nathan Fowler of MD Anderson Cancer Center and

Study Chair of the MZL cohort, to discuss the interim

YORK, NY, April 1, 2019 (GLOBE NEWSWIRE)

TG Therapeutics, Inc.

(NASDAQ: TGTX) today reported positive interim data from the

ongoing single-arm marginal zone lymphoma (MZL) cohort of its Phase

2b clinical trial known as UNITY-NHL. The MZL cohort of UNITY-NHL

is designed to investigate umbralisib as a single agent in patients

with relapsed or refractory MZL. Umbralisib is an investigational,

oral, once daily PI3K delta inhibitor with unique inhibition of CK1

epsilon and is currently under development for the treatment of

non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia

The interim data were reported this morning by Dr. Nathan Fowler,

Associate Professor of Medicine and Director of Clinical Research

in the Department of Lymphoma/Myeloma at the University of Texas MD

Anderson Cancer Center and Study Chair of the UNITY-NHL MZL cohort,

during this morning's official 2019 Press Program at the

American Association of Cancer Research (AACR) Annual Meeting. Dr.

Fowler will also present the data during an oral session this

afternoon (details below).

Summary of Data Presented:

The MZL cohort of UNITY-NHL enrolled patients with relapsed or

refractory MZL who had received prior treatment

with one or more lines of therapy including at least one

anti-CD20 regimen. In August 2018, the

trial completed enrollment with 69 treated patients. The interim

data reported today included safety and tolerability data on all 69

treated patients (safety population) and efficacy data on 42

patients who were enrolled at least 9 cycles (28 day cycles) prior

to the data cut-off date (interim efficacy population). The primary

endpoint is overall response rate (ORR) as assessed by IRC using

criteria adopted from the International Working Group criteria for

Analysis of the interim efficacy population (n=42) with a median

follow-up of 12.5 months showed the following:

CI = confidence interval; NR = not reached; NE = not estimable; SD

Additional Efficacy Highlights:

clinical benefit rate by IRC (defined as patients obtaining

Complete Response + Partial Response + Stable Disease)

patients achieving a Complete Response by IRC remain on study

(range: 10.1+ to 15.7+ months)

of patients had a reduction in tumor burden

time to initial response was 2.7 months

(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):

colitis were reported and only 1 event of Grade 3 pneumonitis was

were limited, occurring in 3 patients (bronchitis, pneumonia, and

due to umbralisib-related AEs were limited (14%) with no

discontinuations after 6 months due to a treatment-related

Dr. Nathan Fowler, Associate Professor of Medicine and Director of

Clinical Research in the Department of Lymphoma/Myeloma at The

University of Texas MD Anderson Cancer Center and the Study Chair

of the UNITY-NHL MZL cohort, stated, MZL remains an

incurable disease with few treatment options for patients who

relapse after first-line chemoimmunotherapy. The exciting results

presented today suggest that this oral targeted therapeutic has

significant activity against relapsed/refractory marginal zone

lymphoma and offers hope for patients. Dr. Fowler continued,

The adverse event and clinical activity data are highly

encouraging at this point and we are excited to continue following

patients for a longer time. With the results reported thus far,

umbralisib has the potential to make a real difference for patients

with relapsed/refractory marginal zone

Michael S. Weiss, Executive Chairman and Chief Executive Officer

of TG Therapeutics stated, "We are very excited about

these interim data and believe the results today demonstrate the

activity and differentiated safety and tolerability profile of

umbralisib at our Phase 3 dose of 800 mg once per day. Mr.

Weiss continued, As announced previously, the efficacy for

the entire population has already reached our target range of