Epizyme, Inc. (NASDAQ:EPZM), a clinical-stage company developing
novel epigenetic therapies, announced positive interim data from an
ongoing Phase 2 study of its lead candidate tazemetostat, a potent,
selective, orally available EZH2 inhibitor, as a monotherapy for
patients with relapsed or refractory follicular lymphoma (FL). The
data, presented today at the 23rd Congress of the European
Hematology Association (EHA) in Stockholm, show that tazemetostat
demonstrated meaningful clinical activity and was generally well
tolerated in these heavily pre-treated patients.
Interim data as of May 1, 2018 included 82 evaluable patients
across two cohorts, prospectively assigned by EZH2 status. In the
EZH2 activating mutation cohort (n=28), an objective response rate
(ORR) of 71 percent was observed; 11 percent of patients achieved a
complete response (CR), and 61 percent achieved a partial response
(PR). Twenty-nine percent achieved stable disease (SD) as best
response; of those, 21 percent are still on study with the
potential to respond. All patients in this cohort experienced
reduction in tumor burden, and no patients experienced progressive
disease (PD) as best response. At the time of this analysis, the
median progression-free survival (PFS) was 49 weeks and the median
duration of response (DOR) was 32 weeks, and both endpoints
continue to mature.
In the fully-enrolled cohort of FL patients with wild-type (WT)
EZH2 (n=54), the ORR was 33 percent; six percent achieved a CR, and
28 percent achieved a PR. An additional 31 percent of patients
achieved SD as best response, including one patient who is still
receiving treatment. At the time of this analysis, the median PFS
was 30 weeks and median DOR was 76 weeks. The median DOR
figure continues to mature, with more than half of the responders
still on therapy.
“I am impressed by the sustained clinical activity and the good
tolerability of tazemetostat in this heavily pre-treated patient
population. This is important for patients with relapsed or
refractory follicular lymphoma, as both the response rates and
durations of response usually tend to decrease with each successive
line of treatment,” said Gilles Salles, M.D., Ph.D., at the
University Hospital of Lyon France, and president of the Lymphoma
Study Association (LYSA) cooperative group. “I believe tazemetostat
has the potential to fill a significant unmet need for these
patients and continued investigation of tazemetostat as single
agent or in combination with other agents is warranted.”
Updated interim clinical activity findings are as follows:
Best Response |
FL with EZH2MT |
FL with EZH2 WT |
Evaluable for efficacy on May 1, 2018 |
n =28 |
n =54 |
Median Prior Lines of Therapy |
3 |
4 |
Objective Response Rate (CR + PR) |
71% (20) |
33% (18) |
Complete Response (CR) |
11% (3) |
6% (3) |
Partial Response (PR) |
61% (17) |
28% (15) |
Stable Disease (SD) |
29% (8) |
31% (17) |
SD study drug ongoing |
21% (6) |
2% (1) |
Progressive Disease |
(0) |
31% (17) |
Median Progression-Free Survival
(PFS) |
48.6+ weeks* |
29.9 weeks |
Median Duration of Response (DOR)
|
32.3+ weeks* |
76.0+ weeks* |
Patients with Response Ongoing† |
55% (11) |
56% (10) |
*median not yet reached; data continue to
mature†includes discontinued patients with
response ongoing at time of discontinuation |
This ongoing global, multi-center Phase 2 study is assessing the
safety and efficacy of 800 mg of tazemetostat, administered orally
twice daily, in adult patients who had received at least two prior
therapies. The two cohorts represented in the interim assessment
included patients with an EZH2 activating mutation or those with WT
EZH2. The primary endpoint is ORR, defined as CR and PR. Secondary
endpoints include PFS, DOR and safety/tolerability.
Tazemetostat was generally well tolerated in this study. Interim
safety results at the time of this analysis show only six percent
of FL patients discontinued treatment due to treatment-related
adverse events (AEs). AEs of Grade 3 or higher were reported
across 17 percent of patients, the most frequent of which included
thrombocytopenia, anemia, asthenia and fatigue.
“Today’s interim update underscores our belief that tazemetostat
may be an important therapeutic candidate in relapsed or refractory
follicular lymphoma and may play a key role in the treatment
landscape, regardless of mutational status,” said Robert Bazemore,
president and chief executive officer of Epizyme. “The patients who
are participating in this study deserve our gratitude. At Epizyme,
we are dedicated to continuing our work with the global
investigator community to resolve the partial clinical hold and
complete enrollment in this study, in an effort to bring
tazemetostat to people living with follicular lymphoma.”
Investor Conference Call ReminderEpizyme will
host an investor conference call and webcast today at 8:30 a.m. EDT
to discuss interim clinical activity and tolerability data from
adult patients with relapsed or refractory FL who are receiving
tazemetostat in the company’s ongoing Phase 2 study. To participate
in the call, please dial (877) 844-6886 (domestic) or (970)
315-0315 (international) and refer to conference ID 4869637. A live
webcast will be available in the investor section of the company’s
website at www.epizyme.com. The webcast will be archived on the
website for 60 days.
About Follicular Lymphoma (FL)An estimated
40,000 people in the U.S. and EU5 are treated for FL each year. FL
is an incurable and deadly form of cancer that is most frequently
treated with multiple lines of systemic chemotherapy. As a result,
there remains a significant need for an effective, convenient and
tolerable medicine that patients can take for long durations.
About the Tazemetostat Clinical Trial
ProgramTazemetostat, a first-in-class EZH2 inhibitor, is
currently being studied as a monotherapy in ongoing Phase 1 and 2
programs in certain molecularly defined solid tumors, including
epithelioid sarcoma (ES) and other INI1-negative tumors; both
follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL)
forms of non-Hodgkin lymphoma (NHL); mesothelioma and combination
studies in DLBCL.
About Epizyme, Inc. Epizyme, Inc. is a
clinical-stage biopharmaceutical company committed to rewriting
treatment for cancer and other serious diseases through novel
epigenetic medicines. Epizyme is broadly developing its
lead product candidate, tazemetostat, a first-in-class EZH2
inhibitor, with studies underway in both solid tumors and
hematological malignancies, as a monotherapy and combination
therapy in relapsed and front-line disease. The company is also
developing a novel G9a program with its next development candidate,
EZM8266, which is targeting sickle cell disease. By focusing on the
genetic drivers of disease, Epizyme's science seeks to
match targeted medicines with the patients who need them. For more
information, visit www.epizyme.com.
Cautionary Note on Forward-Looking Statements
Any statements in this press release about future expectations,
plans and prospects for Epizyme, Inc. and other statements
containing the words "anticipate," "believe," "estimate," "expect,"
"intend," "may," "plan," "predict," "project," "target,"
"potential," "will," "would," "could," "should," "continue," and
similar expressions, constitute forward-looking statements within
the meaning of The Private Securities Litigation Reform Act of
1995. Actual results may differ materially from those indicated by
such forward-looking statements as a result of various important
factors, including: uncertainties relating to the Company’s ability
to resume enrollment in its tazemetostat trials and the timing of
such resumption, and the impact of the safety finding on enrollment
of patients in ongoing and future trials of tazemetostat following
the lifting of the partial clinical hold and the resumption of
enrollment; uncertainties inherent in the initiation of future
clinical studies and in the availability and timing of data from
ongoing clinical studies; whether interim results from a clinical
trial will be predictive of the final results of the trial; whether
results from preclinical studies or earlier clinical studies will
be predictive of the results of future trials; whether results from
clinical studies will warrant meetings with regulatory authorities,
submissions for regulatory approval or review by governmental
authorities under the accelerated approval process; whether Fast
Track Designation and Orphan Drug Designations will provide the
benefits for which tazemetostat is eligible; expectations for
regulatory approvals to conduct trials or to market products;
whether the company's cash resources will be sufficient to fund the
company's foreseeable and unforeseeable operating expenses and
capital expenditure requirements; other matters that could affect
the availability or commercial potential of the company's
therapeutic candidates; and other factors discussed in the "Risk
Factors" section of the company's most recent Form 10-Q filed with
the SEC and in the company's other filings from time to time with
the SEC. In addition, the forward-looking statements included in
this press release represent the company's views as of the date
hereof and should not be relied upon as representing the company's
views as of any date subsequent to the date hereof. The company
anticipates that subsequent events and developments will cause the
company's views to change. However, while the company may elect to
update these forward-looking statements at some point in the
future, the company specifically disclaims any obligation to do
so.
Contacts:
Media:Erin Graves, Epizyme, Inc.media@epizyme.com (617)
500-0615
Investors:Jason Fredette, Epizyme, Inc.ir@epizyme.com(617)
500-0623
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