TESARO Initiates Registrational Development Program for Anti-PD-1 Antibody TSR-042
April 27 2017 - 8:15AM
TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical
company, today announced that following the recent identification
of a fixed dose and patient-centric dosing schedule, the ongoing
clinical trial of TSR-042 has been expanded to enroll patients with
metastatic microsatellite instability high (MSI-H) endometrial
cancer who have progressed following one or two prior chemotherapy
treatments. During the first 12 weeks of treatment, TSR-042 is
administered once every three weeks, followed by a single dose
administration every six weeks until disease progression. The
intent of this study is to support a request for accelerated
approval and Biologics License Application (BLA) submission to the
U.S. Food and Drug Administration (FDA). The primary endpoints of
this trial are overall response rate (ORR) and duration of
response, and secondary endpoints include disease control rate,
progression free survival (PFS), and overall survival (OS). The
addition of cohorts for patients with other tumor types is also
planned. This is the first clinical development program within a
broader plan that includes potential label expansion trials of
TSR-042 in multiple cancers in combination with ZEJULA®, TSR-022,
TESARO’s anti-TIM-3 antibody, and TSR-033, TESARO’s anti-LAG-3
antibody.
“TSR-042 was the first antibody from our
immuno-oncology portfolio to enter clinical trials, and following
identification of a fixed dose and schedule, we are pleased to be
advancing TSR-042 into a registration program,” said Mary Lynne
Hedley, Ph.D., President and COO of TESARO. “With the recent
approval of ZEJULA in the U.S., the initiation of this development
program furthers our commitment to women with gynecologic tumors,
including ovarian, fallopian tube, and peritoneal cancer. We intend
to continue our efforts with future combination studies of TSR-042
and ZEJULA, and to someday eliminate these terrible diseases and
benefit women who were until recently largely underserved by new
therapeutic options.”
About TSR-042
TSR-042 is a monoclonal antibody targeting PD-1
and was developed as part of the collaboration between TESARO and
AnaptysBio, Inc. This collaboration was initiated in March of 2014,
and is focused on the development of monospecific antibody drugs
targeting PD-1, TIM-3 (TSR-022), and LAG-3 (TSR-033), in addition
to a bi-specific antibody drug candidate targeting PD-1/LAG-3.
About Endometrial
CancerEndometrial cancer is the most common type of
uterine cancer, accounting for more than 95 percent of cases.
Endometrial cancer develops in the lining of the uterus, called the
endometrium. The annual number of new cases of endometrial cancer
is estimated at 325,000 worldwide. The most common histologic form
is endometrioid adenocarcinoma originating in the glandular tissue,
which represents about 75-80% of diagnosed cases. In 2017, SEER1
estimates 61,380 patients will be diagnosed with endometrial
cancer, with approximately 30% or 18,414 being stage III/IV
patients. Based on genomic characterization studies of endometrial
cancer, 20-25% of patients have tumors with a microsatellite
instability phenotype (MSI-H)2. Microsatellite instability
arises from a failure to repair replication-associated errors due
to a defective DNA mismatch repair system. This failure allows
persistence of mismatch mutations all over the genome, but
especially in regions of repetitive DNA known as microsatellites,
leading to increased mutational load that has been demonstrated to
improve responses to anti-PD-1 therapies.3,4
About TESAROTESARO is an
oncology-focused biopharmaceutical company devoted to providing
transformative therapies to people bravely facing cancer. For more
information, visit www.tesarobio.com and follow us on Twitter and
LinkedIn.
Forward Looking Statements
To the extent that statements contained in this
press release are not descriptions of historical facts regarding
TESARO, they are forward-looking statements reflecting the current
beliefs and expectations of management made pursuant to the safe
harbor provisions of the Private Securities Litigation Reform Act
of 1995. Words such as "may," "will," "expect," "anticipate,"
"estimate," "intend," and similar expressions (as well as other
words or expressions referencing future events, conditions or
circumstances) are intended to identify forward-looking statements.
Examples of forward-looking statements contained in this press
release include our plans to submit a BLA and seek accelerated FDA
approval for TSR-042, our plans to add cohorts for patients with
other tumor types, and our plans to pursue future combination
studies with TSR-042 and ZEJULA. Forward-looking statements in this
release involve substantial risks and uncertainties that could
cause our clinical development programs, future results,
performance or achievements to differ significantly from those
expressed or implied by the forward-looking statements. Such risks
and uncertainties include, among others, the uncertainties inherent
in the execution and completion of clinical trials, risks
associated with our reliance upon third parties for the conduct of
clinical trials, uncertainties surrounding our ongoing discussions
with and potential actions by regulatory authorities, risks related
to manufacturing and supply, risks related to intellectual
property, and other matters that could affect the timing of
availability of data from or initiation of our planned clinical
trials or the availability or commercial potential of TSR-042.
TESARO undertakes no obligation to update or revise any
forward-looking statements. For a further description of the risks
and uncertainties that could cause actual results to differ from
those expressed in these forward-looking statements, as well as
risks relating to the business of the Company in general, see
TESARO's Annual Report on Form 10-K for the year ended December 31,
2016.
- SEER: National Cancer Institute’s Surveillance, Epidemiology,
and End Results Program
- Kandoth C, Schultz N, Cherniack AD, et al: Integrated genomic
characterization of endometrial carcinoma. Nature 497:67-73,
2013.
- Le DT, Uram JN, Wang H, et al: PD-1 Blockade in Tumors with
Mismatch-Repair Deficiency. N Engl J Med 372:2509-20, 2015.
- Westdorp H, Fennemann FL, Weren RD, et al: Opportunities for
immunotherapy in microsatellite instable colorectal cancer. Cancer
Immunol Immunother 65:1249-59, 2016.
Investor/Media Contact:
Jennifer Davis
Vice President, Corporate Affairs & Investor Relations
+1.781.325.1116 or jdavis@tesarobio.com
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