TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical
company, today summarized initial data from the Phase 1 GARNET
trial of TSR-042 (anti-PD-1 antibody) in patients with
microsatellite instability high (MSI-H) endometrial cancer and
non-small cell lung cancer (NSCLC) presented during the American
Association for Cancer Research (AACR) Annual Meeting.
“Preliminary results from GARNET presented today
at AACR are the first clinical data from expansion cohorts for
TSR-042, our anti-PD-1 antibody,” said Mary Lynne Hedley, Ph.D.,
President and COO of TESARO. “These results demonstrate the
clinical activity of TSR-042 and support our unique patient-centric
dosing regimen that includes dosing every 6 weeks. We expect to
complete enrollment in the MSI-H endometrial cohort of the GARNET
trial by the end of the year. A regulatory submission for TSR-042
is planned in 2019. The breadth of TESARO’s immuno-oncology
portfolio, which also includes antibodies targeting TIM-3 and
LAG-3, enables us to evaluate both monotherapy and novel
combination approaches with a goal of providing transformative
therapies for people living with cancer.”
Preliminary Activity in MSI-H
Endometrial Cancer and Non-Small Cell Lung CancerGARNET is
a multicenter, open-label, Phase 1 dose-escalation study designed
to assess the safety, pharmacokinetics, pharmacodynamics, and
clinical activity of TSR-042 in patients with advanced solid
tumors. Part 1, a weight-based dose escalation study, and part 2A,
a fixed-dose safety study, of GARNET have been completed. The
ongoing part 2B expansion portion of GARNET is evaluating TSR-042
at a dose of 500 milligrams every 3 weeks for the first 4 cycles,
and 1000 milligrams every 6 weeks thereafter in four open cohorts:
MSI-H endometrial cancer, MSI-high non-endometrial cancer, MSS
endometrial cancer and NSCLC. Data presented at AACR included
efficacy data from the cohorts of patients with MSI-H endometrial
cancer and NSCLC from part 2B of the trial.
At the time of data cutoff, 15 patients with
MSI-H endometrial cancer and 24 patients with NSCLC had at least 1
tumor assessment. Among the 15 patients with MSI-H endometrial
cancer, 7 had partial responses by immune related RECIST (irRECIST)
criteria (ORR 47%). Eleven patients continue on therapy, including
one patient with a partial response who has thus far received over
42 weeks of TSR-042. Three additional patients (20%) had stable
disease.
Among the 24 patients with NSCLC, 7 had partial
responses by irRECIST criteria (ORR 29%). Twelve patients continue
on therapy, including one patient with a partial response who has
thus far received over 36 weeks of TSR-042. Ten additional patients
had stable disease (42%), one of whom has continued treatment for
over 36 weeks.
Preliminary safety findings among the 120
evaluable patients (including patients with MSI-H endometrial,
NSCLC, and other tumor types) indicate TSR-042 is well-tolerated.
Grade ≥3 treatment-related treatment-emergent adverse events
(TEAEs) were reported in 9 of 120 patients (7%).
Serum concentrations of TSR-042 observed 6 weeks
after the 1000 milligram dose were comparable to those observed 3
weeks after the 500 milligram dose, and maximal receptor occupancy
was maintained throughout the 6-week dosing interval.
The GARNET study is intended to support a
Biologics License Application (BLA) submission to the U.S. Food and
Drug Administration (FDA) for patients with MSI-H cancers in
2019.
TESARO Poster Presentations at
AACR (all times local)
Immuno-oncologyMonday, April
16, 2018, 8:00 AM to 12:00 PMPreliminary safety, efficacy and PK/PD
characterization from GARNET, a phase I clinical trial of the
anti-PD-1 monoclonal antibody, TSR-042, in patients with recurrent
or advanced NSCLC or MSI-H endometrial cancerPoster Session,
Abstract: CT053, Location: Exhibit Hall A, Poster Section 42,
Poster Board 6
Monday, April 16, 2018, 8:00 AM to 12:00
PMCheckpoint inhibitor signatures across endometrial cancer
histologiesPoster Session, Abstract: 1687, Location: Exhibit Hall
A, Poster Section 31, Poster Board 12
Monday, April 16, 2018, 8:00 AM to 12:00
PMSimultaneous measurement and significance of PD-1, LAG-3 and
TIM-3 expression in human solid tumorsPoster Session, Abstract:
1681, Location: Exhibit Hall A, Poster Section 31, Poster Board
6
Monday, April 16, 2018, 1:00 PM to 5:00
PMInvestigation of the expression profile and functional role of
PD-1, TIM-3 and LAG-3 in human tumorsPoster Session, Abstract:
2722, Location: Exhibit Hall A, Poster Section 32, Poster Board
14
Wednesday, April 18, 2018, 8:00 AM to 12:00
PMCharacterization of tumor growth and immune microenvironment in
humanized NOG-EXL mice implanted with A549, MDA-MB-436 and A375
cellsPoster Session, Abstract: 5690, Location: Exhibit Hall A,
Poster Section 31, Poster Board 26
About GARNETThe ongoing Phase I
GARNET trial is evaluating TSR-042 as monotherapy in patients with
advanced solid tumors. GARNET included a weight-based dose
escalation study (Part 1) and a fixed-dose safety study (Part 2A),
both of which have been completed. Results of these studies were
used to determine the recommended Phase 2 dose (RP2D; 500 mg Q3W
for the first 4 cycles then 1000 mg Q6W). The study is now
enrolling patients with MSI-H endometrial cancer, MSI-H
non-endometrial cancer, MSS endometrial cancer, and NSCLC into four
large expansion cohorts.
About TSR-042TSR-042 is an
investigational humanized anti-programmed death (PD)-1 monoclonal
antibody that binds with high affinity to the PD-1 receptor and
effectively blocks its interaction with the ligands PD-L1 and
PD-L2. TSR-042 is the only anti-PD-1 therapy administered as
monotherapy every 3 weeks for 4 doses then every 6 weeks
thereafter. TSR-042 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 (TSR-075).
About TESAROTESARO is an
oncology-focused biopharmaceutical company devoted to providing
transformative therapies to people facing cancer. For more
information, visit www.tesarobio.com, and follow us on Twitter and
LinkedIn.
Investor/Media
Contacts:Jennifer DavisVice President, Corporate
Communications & Investor Relations+1.781.325.1116 or
jdavis@tesarobio.com
Kate RauschAssociate Director, Investor
Relations+1.781.257.2505 or krausch@tesarobio.com
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, among others, statements regarding the potential
dosing schedule for TSR-042, the timing of expected completion of
enrollment of the MSI-H endometrial cohort, and the expected timing
of our planned regulatory submission for TSR-042. Forward-looking
statements in this release involve substantial risks and
uncertainties that could cause our 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 and regulatory
submissions, uncertainties surrounding the timing of availability
of data from clinical trials, uncertainties surrounding potential
actions by regulatory authorities such as the US FDA, risks related
to manufacturing and supply, risks related to intellectual
property, and other matters that could affect our ongoing and
planned development programs, and/or the availability or commercial
potential of our products and product candidates, including
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,
2017.
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