TG Therapeutics Presents Positive Interim Data from UNITY-NHL Phase 2b Trial Evaluating Umbralisib Monotherapy in Patients wi...
June 04 2019 - 4:02PM
TG Therapeutics, Inc. (NASDAQ: TGTX) today presented positive
interim data from the ongoing single-arm marginal zone lymphoma
(MZL) cohort of its Phase 2b UNITY-NHL trial currently evaluating
umbralisib as a single agent in patients with relapsed/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 (CLL).
The interim data were presented today in an oral session during
the 55th American Society of Clinical Oncology (ASCO) Annual
Meeting. The slides presented are available on the Company’s
corporate website at www.tgtherapeutics.com/publications.cfm.
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 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 for malignant lymphoma.
Efficacy
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:
- 52% ORR, with 17% CR, by IRC assessment for patients who had
received 2 or more prior lines of therapy, n=23
- 88% clinical benefit rate by IRC, n=42, (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)
- 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
Safety
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.
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
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 (ORR) as
determined by central Independent Review Committee (IRC)
assessment.
The MZL cohort completed enrollment in August 2018 with a total
of 69 patients enrolled and receiving at least one dose of
umbralisib. In February of 2019, the Company announced that the MZL
cohort met its primary endpoint of ORR as determined by central IRC
for all treated patients (n=69). While the study has already met
the Company’s target guidance of 40-50% ORR, the final analysis of
ORR will be conducted when 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
(PFS).
ABOUT BREAKTHROUGH THERAPY DESIGNATION The
Company announced in January of 2019 that the U. S. Food and Drug
Administration (FDA) granted Breakthrough Therapy Designation for
umbralisib for the treatment of adult patients with marginal
zone lymphoma who have received at least one prior anti-CD20
regimen.
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.
ABOUT TG THERAPEUTICS, INC.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.
Cautionary StatementSome 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
ORR and/or enhanced toxicities, which may not support a filing for
accelerated approval; the risk that even if the Interim Results are
reproduced in the final analysis of the UNITY-NHL MZL cohort or
that the final results otherwise meet the Company’s target ORR of
40-50%, that the final results will still be insufficient to
support a filing for accelerated approval; the risk that umbralisib
will not receive accelerated approval based on data from the
UNITY-NHL MZL cohort even if the final results are deemed positive
by the Company and support a filing for accelerated approval; the
risk that the positive Interim Results from the UNITY-NHL MZL
cohort will not be reproduced in other cohorts of the UNITY-NHL
study or in other studies being conducted by the Company; the risk
that duration of response or progression free survival data from
the UNITY-NHL cohort when available for all patients will not be
positive or supportive of accelerated approval; the risk that
safety issues will arise when the final safety data are cleaned and
analyzed for all patients in the UNITY-NHL MZL cohort; the risk
that our belief that umbralisib has a differentiated safety profile
will not be shared by physicians or the FDA or will not be
reproduced in the final analysis of the UNITY-NHL MZL cohort, in
other cohorts of the UNITY-NHL study, in the UNITY-CLL study or in
any other of our on-going studies; the risk that the anticipated
timelines for data releases and potential filings for approval will
be delayed due to a variety of factors, including, without
limitation, available resources, program reprioritization, slower
than expected event rates for UNITY-CLL and/or requests from FDA or
foreign regulators; the risk that we are not able to successfully
and cost effectively complete all the preclinical, clinical and CMC
requirements necessary to support accelerated approval. Any
forward-looking statements set forth in this press release speak
only as of the date of this press release. We do not undertake to
update any of these forward-looking statements to reflect events or
circumstances that occur after the date hereof. This press release
and prior releases are available at www.tgtherapeutics.com.
The information found on our website is not incorporated by
reference into this press release and is included for reference
purposes only. CONTACT: Jenna A. BoscoSenior Vice President,
Corporate CommunicationsTG Therapeutics, Inc.Telephone:
212.554.4351Email: ir@tgtxinc.com
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