Epizyme Announces Registration Path for Tazemetostat for Follicular Lymphoma and Provides Pipeline Updates and 2019 Guidance
January 04 2019 - 6:30AM
Business Wire
Path Defined to Submit for Accelerated Approval
in All FL Patients after at least Two Prior Lines of Therapy Based
on Fully Enrolled Phase 2 Study
Operating Runway Extended into the Second
Quarter of 2020
Conference Call to be Held Today, Jan. 4, at
8:30 a.m. ET
Epizyme, Inc. (Nasdaq: EPZM), a clinical-stage company
developing novel epigenetic therapies, today announced a
comprehensive set of pipeline updates, including that the company
has identified a path to submission for accelerated approval of
tazemetostat for patients with relapsed and/or refractory
follicular lymphoma (FL), both with and without EZH2 activating
mutations. The company recently conducted a productive meeting with
the U.S. Food and Drug Administration (FDA) to discuss the FL
registration strategy based on the current patient population in
its ongoing Phase 2 clinical trial. Following the discussion,
Epizyme has defined a registration strategy for tazemetostat in
both EZH2 mutant and wild type FL patient populations, where
patients’ disease has progressed following two or more lines of
therapy. Based on this, the company anticipates submitting a New
Drug Application (NDA) for this indication in the fourth quarter of
2019. In addition, the company provided an update on its clinical
and preclinical pipeline and anticipated milestones for 2019.
“Follicular lymphoma is an incurable cancer today, and in the
third line and later settings, there are limited effective
treatment options. Defining a clear path to a regulatory submission
for tazemetostat for this patient population marks a huge step
forward for patients and an opportunity to change the course of FL
treatment,” said Shefali Agarwal, M.D., chief medical officer of
Epizyme. “This FL NDA submission would mark the second for
tazemetostat in one year, following our first submission for
epithelioid sarcoma, which is on track for the second quarter of
2019. If successful, tazemetostat is poised to be the first
commercially available EZH2 inhibitor. We look forward to advancing
our submission preparations and further engaging with FDA, as we
work expeditiously to bring tazemetostat to the patients who need
it.”
Tazemetostat Registration Update for Follicular
Lymphoma
- Phase 2 Study Fully Enrolled:
The ongoing Phase 2 study has been fully enrolled and based on
discussions with FDA, is expected to provide the necessary relapsed
and/or refractory FL patients needed for an NDA submission, with 45
patients with EZH2 activating mutations and 54 patients with
wild-type EZH2.
- Registration Path Identified for NDA
Submission in Follicular Lymphoma: Epizyme recently met with
FDA to review its planned registration strategy for tazemetostat
for patients with FL who have been previously treated with two or
more systemic therapies, which represents a population of unmet
medical need. The company has identified a path to a submission for
accelerated approval for patients with both mutant and wildtype
EZH2, based on the ongoing Phase 2 study. Epizyme will further
advance the Phase 2 study, with updated data to be reported at a
medical meeting in mid-2019 and an NDA submission targeted for the
fourth quarter of 2019.
- Confirmatory Program Could Support
Expansion into Earlier Treatment Lines of Follicular Lymphoma:
As part of an accelerated approval strategy, Epizyme plans to
conduct a confirmatory program to support full approval of
tazemetostat in FL, while also supporting its potential expansion
into the second-line treatment of FL. Under its Fast Track
designation, the company intends to engage with FDA in the first
half of 2019 to discuss the confirmatory program and will share
details upon initiation.
Tazemetostat Registration Update for Epithelioid
Sarcoma
- NDA Submission for Epithelioid
Sarcoma on Track for Second Quarter of 2019: Epizyme is
advancing preparations for its first NDA submission for
tazemetostat in the second quarter of 2019 using the accelerated
approval pathway for the treatment of patients with epithelioid
sarcoma (ES). ES is an ultra-rare and difficult-to-treat sarcoma
with no specifically indicated FDA-approved therapies today. If
approved, tazemetostat could be the first treatment specifically
indicated for patients with ES. The company has begun
pre-commercial activities, with plans to commercialize tazemetostat
on its own in the U.S.
Tazemetostat Program Expansion Updates
- Combination Study to Begin in
Follicular Lymphoma in 2019: Based on the monotherapy efficacy
and safety data generated to-date, Epizyme plans to explore the
potential of tazemetostat in earlier lines of FL as combination
therapy. The company is assessing the opportunity to conduct a
combination study that would compare the chemo-free combination of
rituximab and Revlimid® (R2) with tazemetostat versus R2 with
placebo in patients with relapsed or refractory FL. Epizyme plans
to provide an update on its combination study plans once they have
been finalized.
- R-CHOP Combination Data Further
Support Tazemetostat Combination Potential: Under its
collaboration agreement with Epizyme, the Lymphoma Study
Association (LYSA) reported data at the 2018 American Society of
Hematology Annual Meeting on the combination of tazemetostat with
R-CHOP as a front-line treatment for patients with diffuse large
B-cell lymphoma. The data showed that the combination of the two
agents was generally well-tolerated, confirmed the recommended
tazemetostat dose for the combination to be 800mg twice-daily and
demonstrated clinical activity, with 87 percent of patients
experiencing a metabolic complete response. Based on these data,
Epizyme is considering opportunities to expand the evaluation of
this combination into patients with FL.
- Plans in Place to Expand
Tazemetostat into New Indications and Combinations: Based on
its mechanism of action, favorable safety reported and demonstrated
activity in multiple tumor types and treatment settings, Epizyme
plans to expand tazemetostat’s potential utility into additional
combinations and indications. The company has identified the next
set of clinical assessments for tazemetostat, including a
combination study in castration-resistant prostate cancer that is
slated to begin in mid-2019, and assessment in platinum-resistant
tumors, such as small-cell lung cancer, triple-negative breast
cancer and ovarian cancer, slated to begin in the second half of
2019.
- Genentech and Epizyme to Close
Tecentriq® Combination Assessment in NSCLC: As
part of a collaboration agreement, Genentech/Roche initiated
assessment of tazemetostat in combination with Tecentriq for the
treatment of non-small cell lung cancer (NSCLC) in an arm of its
MORPHEUS NSCLC Trial. Before patients had been enrolled in the
study, recruitment was halted due to the partial hold placed on
tazemetostat studies. Epizyme has since reopened enrollment in the
U.S. and Germany for studies for which it is the sponsor. Due to
the hold and strategic reprioritizations, the companies have
jointly opted not to move forward with the NSCLC combination
study.
Preclinical and Discovery Pipeline Update
- EZM8266 on Track to Begin Clinical
Development: Throughout 2018, Epizyme conducted IND-enabling
studies on its next development candidate, EZM8266, a novel G9a
inhibitor for the treatment of sickle cell disease. The company is
on track to begin clinical development of EZM8266 in the second
half of 2019 with a dose-finding and safety study.
- Two Research Programs to Be Advanced
under Boehringer Ingelheim Collaboration: In November 2018,
Epizyme entered a strategic collaboration with Boehringer Ingelheim
focused on the research, development and commercialization of novel
small molecule inhibitors directed toward two previously
unaddressed epigenetic targets as potential therapies for people
with cancer. Specifically, these targets are enzymes within the
helicase and histone acetyltransferase (HAT) families that when
dysregulated have been linked to the development of cancers that
currently lack therapeutic options.
Updated Financial Guidance
- Based on enhanced operating
efficiencies, partner revenues and proceeds from the company’s
underwritten public offering completed in October 2018, Epizyme has
extended its expected capital runway into the second quarter of
2020 based on current operating plans.
“We are at a point in our company’s evolution where we are
beginning to realize the true value of all of the hard work to
which we have dedicated ourselves over the past several years. 2019
is set to be a year of pivotal milestones for Epizyme, providing
validation of our expertise in drug development and bringing us
closer to achieving our mission of helping patients,” said Robert
Bazemore, president and chief executive officer of Epizyme. “With
defined registration paths for tazemetostat in two indications and
plans to expand into other combinations and indications,
tazemetostat has the potential to generate significant value for
the patients and physicians who need new treatment options, and for
Epizyme. Outside of tazemetostat, our research capabilities provide
additional advantages to our company, and we are excited to be
moving EZM8266 into the clinic and working with our partners to
advance earlier programs. I am proud of what we have accomplished,
and look forward to what is ahead as we transition to a
commercial-stage company that can truly have an impact on
patients.”
Conference Call InformationEpizyme will host a conference
call today, Jan. 4, at 8:30 a.m. ET to review this corporate
update. To participate in the conference call, please dial (877)
844-6886 (domestic) or (970) 315-0315 (international) and refer to
conference ID 7289720. A live webcast and slides will be available
in the investor section of the company's website at
www.epizyme.com. The webcast and slides will be archived for 60
days following the call and presentation.
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 also is 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 StatementsAny
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 in the company’s
pediatric trial 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20190104005033/en/
Media:Erin Graves, (617) 500-0615Epizyme,
Inc.media@epizyme.com
Investors:Monique Allaire, (617) 896-9511THRUST Strategic
Communicationsmonique@thrustsc.com
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