TESARO, Inc. (NASDAQ: TSRO), an oncology-focused biopharmaceutical
company, today presented initial data from the Phase 1 AMBER trial
of TSR-022 (anti-TIM-3 antibody) in combination with TSR-042
(anti-PD-1 antibody) in patients who have progressed following
anti-PD-1 therapy treatment, in an oral session during the 2018
Annual Meeting of the Society for Immunotherapy of Cancer (SITC)
Conference in Washington, D.C. Additionally, Phase 1 GARNET data of
TSR-042 in patients with previously treated recurrent/advanced
non-small cell lung cancer (NSCLC) and Phase 1 monotherapy
dose-escalation data for TSR-033 (anti-LAG-3 antibody) in a broad
range of solid tumors were also highlighted in poster
presentations.
“The initial AMBER data featured at this year’s
SITC conference are the first clinical data to be presented for an
anti-TIM-3 antibody in combination with an anti-PD-1 antibody and
demonstrated that the combination of TSR-022 and TSR-042 is active
and generally well tolerated in NSCLC and melanoma patients who
have progressed following anti-PD-1 treatment,” stated Mary Lynne
Hedley, Ph.D., President and COO of TESARO. “Additionally, updated
results from the GARNET trial demonstrated robust clinical activity
of TSR-042 in previously treated, anti-PD-1 naive patients with
recurrent or advanced NSCLC, the vast majority of which had TPS
<50%. We look forward to presenting additional data from these
studies in 2019.”
A Phase 1 study of TSR-022, an
anti-TIM-3 monoclonal antibody, in combination with TSR-042, an
anti-PD-1 antibody (AMBER) [Oral presentation; Abstract: 10877;
Poster: O21]
AMBER is an ongoing, open-label, Phase 1 study of TSR-022, an
anti-TIM-3 antibody, in monotherapy or in combination with TSR-042,
an anti-PD-1 antibody. The TSR-022 and TSR-042 combination portion
of the study consists of dose-escalation and expansion
cohorts. Data presented at SITC included safety and efficacy
data from the combination dose-escalation and two expansion
cohorts: NSCLC patients that had progressed following anti-PD-1
treatment and melanoma patients that had progressed following
anti-PD-1 treatment. Patients were treated with 100 milligrams or
300 milligrams of TSR-022 in combination with a fixed dose of
TSR-042 (500 milligrams) every 3 weeks. A dose response trend was
observed in both the NSCLC and melanoma cohorts based on greater
clinical activity observed in patients treated with a 300 milligram
dose of TSR-022 as compared to a 100 milligram dose.
At the time of data cutoff, 39 patients with
NSCLC who had progressed following anti-PD-1 treatment had received
treatment with the TSR-022 and TSR-042 combination, including 14
patients at the 100 milligram dose and 25 patients at the 300
milligram dose of TSR-022. Among the 11 evaluable patients treated
with the 100 milligram dose of TSR-022, 1 had a confirmed partial
response by immune related RECIST (irRECIST) criteria and 3 had
stable disease. Among the 20 evaluable patients treated with the
300 milligram dose of TSR-022, 3 had confirmed partial responses
and 8 had stable disease. All objective responses were in PD-L1
positive (TPS ≥ 1%) patients, indicating potential for biomarker
enrichment. Sixteen patients had known PD-L1 positive tumors. Among
the 12 evaluable patients with PD-L1 positive tumors treated with
either the 100 or 300 milligram dose of TSR-022, 4 patients had
confirmed partial responses (3 responses ongoing) and 6 had stable
disease.
Preliminary safety findings indicate that the combination of
TSR-022 and TSR-042 was generally well-tolerated. Pharmacokinetic
analysis showed that a 300 mg dose is not sufficient to maintain
maximal pharmacodynamic effect and suggests that a 900 milligram
dose of TSR-022 should maintain a maximal effect in the vast
majority of patients for the duration of the Q3W dosing interval.
Patients with NSCLC who have progressed following anti-PD-1
treatment are currently being enrolled in the NSCLC expansion
cohort at the 900 milligram dose of TSR-022 in combination with
TSR-042. Additional data from this cohort (900 milligram
dose) and the melanoma cohort (100 and 300 milligram doses) are
expected in 2019.
GARNET: Preliminary safety, efficacy,
pharmacokinetic, and biomarker characterization from a Phase 1
clinical trial of TSR-042 (anti-PD-1 monoclonal antibody) in
patients with previously treated recurrent/advanced NSCLC [Poster:
P326; Abstract: 10853]
GARNET is an ongoing Phase 1 study evaluating
TSR-042 as a monotherapy in patients with advanced solid tumors.
The ongoing cohort expansion portion of GARNET is evaluating
TSR-042 at a dose of 500 milligrams every 3 weeks for the first 4
cycles and 1,000 milligrams every 6 weeks thereafter in four
cohorts: MSI (microsatellite instability)-high endometrial cancer,
MSI-high non-endometrial cancer, MSS (microsatellite-stable)
endometrial cancer and previously treated recurrent / advanced
anti-PD-1 naïve NSCLC. Data presented at SITC included safety and
efficacy data from the cohort of patients with NSCLC, which is
fully enrolled.
At the time of data cutoff, 67 patients with
previously treated recurrent / advanced anti-PD-1 naive NSCLC had
received treatment with TSR-042, and 47 patients had at least one
post-baseline tumor assessment or had discontinued treatment prior
to first baseline assessment. Among these 47 patients, 15 had
partial responses (including 2 unconfirmed responses that have not
yet progressed) by irRECIST criteria for an overall response rate
(ORR) of 31.9%; 14 additional patients (29.8%) had stable disease.
Responses were durable and nine of the 15 responses are ongoing
(60%).
The majority of patients (32 of 34; 94%) with
available PD-L1 status had TPS <50% and clinical activity of
TSR-042 was observed across all PD-L1 TPS categories. Among the 32
patients with low PD-L1 expression, 13 patients had TPS 1-49%, of
which 5 had partial responses (ORR of 38.5%; including one
unconfirmed response), and 19 patients had TPS <1%, of which 3
had partial responses (ORR of 15.8%).
Preliminary safety findings indicate TSR-042 was
generally well-tolerated, with a safety profile characteristic of
approved anti-PD-1 inhibitors for NSCLC.
The GARNET study is intended to support a
Biologics License Application (BLA) submission to the U.S. Food and
Drug Administration (FDA) in 2019 for patients with recurrent
endometrial cancer.
A Phase 1 dose escalation study of
TSR-033, an anti-LAG-3 monoclonal antibody, in patients with
advanced solid tumors (CITRINO) [Poster Number:
P325; Abstract: 10332]
Data from the monotherapy dose-escalation
portion of the CITRINO study were presented and included 30
patients treated with different doses of TSR-033. There were no
Grade ≥3 treatment-related treatment emergent adverse events
reported. Exposure and peripheral receptor occupancy increased in a
dose proportional manner from 20 milligrams to 720 milligrams.These
preliminary findings indicate that TSR-033 was generally well
tolerated across multiple dose levels, with a safety profile
consistent to those of other immune checkpoint inhibitors.
Enrollment is ongoing for patients treated with
TSR-033 in combination with 500 milligrams of TSR-042.
Investor Briefing and
WebcastTESARO will host an investor and analyst briefing
in New York City on Monday, November 12 at 8:15AM local time. A
reception will begin at 8:00AM ET, preceding the presentation.
During the briefing, TESARO management will provide an overview of
the Company’s immuno-oncology pipeline, followed by a detailed
review of recent data presentations. The presentation will be
followed by Q&A. This event will be webcast live and archived
for 30 days, and may be accessed from the TESARO Investor Events
and Presentations webpage at www.tesarobio.com.
About the AMBER StudyAMBER is
an ongoing Phase 1 study of TSR-022, an anti-TIM-3 antibody, alone
and in combination with TSR-042, an anti-PD-1 antibody. The study
consists of two parts: dose escalation and cohort expansion. The
monotherapy and combination dose-escalation parts of the study are
complete. In the combination dose-escalation, patients were treated
with 100 milligrams, 300 milligrams, or 900 milligrams of TSR-022
in combination with a fixed dose of TSR-042 (500 milligrams) every
3 weeks. The three expansion cohorts include NSCLC patients with
progression following anti-PD-1 treatment, melanoma patients with
progression following anti-PD-1 treatment, and colorectal cancer
patients.
About the GARNET StudyGARNET is
an ongoing multicenter, open-label, Phase 1 study of TSR-042 as a
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 ongoing cohort expansion portion of GARNET is evaluating
TSR-042 in four cohorts: MSI (microsatellite instability)-high
endometrial cancer, MSI-high non-endometrial cancer, MSS
(microsatellite-stable) endometrial cancer and previously treated
recurrent / advanced anti-PD-1 naïve NSCLC.
About the CITRINO StudyCITRINO
is an ongoing multicenter, open-label Phase 1 study evaluating
TSR-033, an anti-LAG-3 antibody, alone or in combination with an
TSR-042 in patients with advanced solid tumors in a broad range of
solid tumors.
About TSR-042, TSR-022, and
TSR-033TSR-042 is an investigational humanized
anti-programmed death (PD)-1 monoclonal antibody that binds with
high affinity to the PD-1 receptor and blocks its interaction with
the ligands PD-L1 and PD-L2. TSR-042 is the only anti-PD-1 therapy
being studied 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 Contact:Kate
RauschDirector, 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 potential dose for TSR-022, the
expected timing of our clinical trial readouts, 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, TSR-022, and TSR-033. 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 and Quarterly Report on Form 10-Q for
the quarter ended September 30, 2018.
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