Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage
oncology company developing first-in-class1 therapeutics that
combine both targeted and immune-mediated mechanisms, today
announced new and updated positive results from the planned data
analysis of an ongoing global randomized Phase 1b/2 clinical study
in which TPST-1120, Tempest’s PPAR⍺ antagonist, shows clinical
superiority in multiple study endpoints when combined with
atezolizumab and bevacizumab in a randomized comparison to
atezolizumab and bevacizumab in the first-line treatment of
patients with unresectable or metastatic hepatocellular carcinoma
(“HCC”).
“This comprehensive analysis of more mature
clinical data shows an even greater benefit than the earlier
interim analysis of the TPST-1120 triplet therapy over standard of
care alone, both for the entire study population and in
subpopulations of patients, the latter of which was predicted by
TPST-1120’s proposed mechanism of action,” said Stephen Brady,
president and chief executive officer of Tempest. “First-line HCC
remains an indication with substantial opportunity to improve
patient outcomes and, based upon these data, we are excited about
the opportunity to move TPST-1120 into a pivotal study. Given these
new data and the Phase 1 evidence of activity beyond HCC, we look
forward to advancing discussions with potential partners who share
our vision for TPST-1120.”
These new data were provided by F. Hoffman
La-Roche (“Roche”) from a clinical collaboration pursuant to which
Roche managed the study operations for this multicenter trial.
Tempest retains all product rights to TPST-1120. Data from 40
patients randomized to the TPST-1120 arm and 30 patients randomized
to the control arm, with a median follow-up of 9.2 and 9.9 months,
respectively, show:
-
Confirmed objective response rate (“cORR” or “confirmed ORR”) of
30% for the TPST-1120 triplet arm versus 13.3% for the atezolizumab
+ bevacizumab control arm; duration of response (“DoR”) has not yet
been reached
-
Hazard ratio (“HR”) favors the TPST-1120 arm for key survival
endpoints
-
Progression free survival (“PFS”): median PFS of 7 mo (5.6 mo, 13.8
mo) for TPST-1120 arm versus 4.27 mo (2.8 mo, 7.3 mo) for the
control arm; HR of 0.7 favors TPST-1120 arm and is not yet
mature
-
Overall survival (“OS”): median OS not reached for the TPST-1120
arm (10.84 mo, NE) versus 15.1 mo (7.49 mo, NE) for the control
arm; HR 0.59 favors TPST-1120 arm and is not yet mature
-
New biomarker subpopulation findings are consistent with the
mechanism of action of TPST-1120
-
Patients with b-catenin activating mutations (21% in this study
(n=7)) showed a cORR of 43% and a disease control rate (“DCR”) of
100% in the TPST-1120 arm
-
Distinct from the control arm, the TPST-1120 arm was consistently
active across both PD-L1 positive and PD-L1 negative tumors, with a
cORR of 27% in the TPST-1120 arm compared to 7% for the control arm
in PD-L1 negative tumors
-
40% of the patients in the TPST-1120 arm were on treatment (16/40)
compared to 16.7% in the atezolizumab + bevacizumab control arm
(5/30)
-
72.5% of the patients on the TPST-1120 arm were on study (29/40),
compared to 46.7% on the atezolizumab + bevacizumab control arm
(14/30)
-
TPST-1120 remains well tolerated, with safety data comparable
between the two arms
-
The randomized arms were generally well balanced at baseline
Secondary endpoints include DoR, PFS, and OS,
which are not fully mature as of the data cut. In Roche’s
IMbrave150 Phase 3 trial, confirmed ORR benefit correlated with
overall survival (OS) benefit.2
Enrollment began in fall of 2021 and the cutoff
date for these data was April 20, 2023. Tempest expects the data
set to be jointly presented by Roche and Tempest at a medical
meeting at a later date. ORR was determined by RECIST v1.1, and
confirmed responses included at least two scans.
Conference Call & Webcast
Information
Tempest will host a webcast conference call
today, October 11, 2023 at 8:30am ET.
To join the conference call via phone and
participate in the live Q&A session, please pre-register online
here to receive a telephone number and unique passcode required to
enter the call. The live webcast and audio archive of the
presentation may be accessed on the investor section of the Tempest
website at https://ir.tempesttx.com/. The webcast will be
available for replay for 30 days.
About the Randomized Clinical Trial
The Phase 1b/2 global randomized HCC study is
part of Roche’s Morpheus program and evaluates TPST-1120 in
combination with atezolizumab and bevacizumab versus atezolizumab
and bevacizumab, the standard of care, in patients with
unresectable or metastatic HCC not previously treated with systemic
therapy. The trial enrolled 70 patients to the TPST-1120 arm and
contemporaneous control arm at approximately 25 sites worldwide,
including in the United States, Europe, and Asia, who received
either the TPST-1120 combination or atezolizumab and bevacizumab
with primary efficacy endpoint of objective response rate, and key
secondary endpoints including PFS and OS. Under the terms of the
clinical collaboration agreement, Roche is managing the study
operations for this global, multicenter trial and Tempest retains
all product rights.
About TPST-1120
TPST-1120 is an oral, small molecule, selective
PPAR⍺ antagonist wholly-owned by Tempest. Tempest’s data suggest
that TPST-1120 treats cancer by targeting tumor cell metabolism
directly, as well as by modulating immune suppressive cells and
angiogenesis in the tumor microenvironment. In a Phase 1 clinical
trial in patients with heavily-pretreated advanced solid tumors,
TPST-1120 as monotherapy and in combination with the PD-1 inhibitor
nivolumab demonstrated tumor reduction (including according to
RECIST criteria), as well as biomarker modulation. TPST-1120 was
well-tolerated both as a monotherapy and in combination with
nivolumab.
About Hepatocellular
Carcinoma
HCC is an aggressive cancer with rising
mortality and is projected to become the third leading cause of
cancer death by 2030.3 Every year, more than 900,000 people
worldwide are diagnosed with HCC.4 Incidence and mortality are
highest in East Asia and are increasing in parts of Europe and the
US.5 In the US, HCC represents the fastest-rising cause of
cancer-related death.3
Nine out of ten cases of HCC are caused by
chronic liver disease, which includes chronic hepatitis B and C
infection, non-alcoholic fatty liver disease (NAFLD), non-alcoholic
steatohepatitis (NASH), alcohol-related liver disease (ALD) and
cirrhosis resulting from these conditions.6
Even if diagnosed in the early stage, an
estimated 70-80% of people with early-stage HCC experience disease
recurrence following surgery.7 Early recurrence is associated with
poorer prognosis and shorter survival.5,8 Tumor size, number of
tumors, and portal vein invasion are associated with an increased
risk of recurrence.6
About Tempest Therapeutics
Tempest Therapeutics is a clinical-stage
oncology company advancing small molecules that combine both
tumor-targeted and immune-mediated mechanisms with the potential to
treat a wide range of tumors. The company has a diverse portfolio
of novel programs ranging from early research to investigation in a
randomized global study in first-line cancer patients. The
company’s two novel clinical programs, TPST-1120 and TPST-1495,
target PPARα and EP2/EP4, respectively, and are advancing through
trials designed to study the agents as monotherapies and in
combination with approved agents. Tempest is also developing an
orally available inhibitor of TREX1, a target that controls
activation of the cGAS/STING pathway. Tempest is headquartered in
Brisbane, California. More information about Tempest can be found
on the company’s website at www.tempesttx.com.
Forward-Looking Statements
This press release contains forward-looking
statements (including within the meaning of Section 21E of the
Securities Exchange Act of 1934, as amended, and Section 27A of the
Securities Act of 1933, as amended (the “Securities Act”)
concerning Tempest Therapeutics, Inc. (“Tempest Therapeutics”).
These statements may discuss goals, intentions, and expectations as
to future plans, trends, events, results of operations or financial
condition, or otherwise, based on current beliefs of the management
of Tempest Therapeutics, as well as assumptions made by, and
information currently available to, management of Tempest
Therapeutics. Forward-looking statements generally include
statements that are predictive in nature and depend upon or refer
to future events or conditions, and include words such as “may,”
“will,” “should,” “would,” “could”, “expect,” “anticipate,” “plan,”
“likely,” “believe,” “estimate,” “project,” “intend,” and other
similar expressions. All statements that are not historical facts
are forward-looking statements, including any statements regarding
the availability of data from clinical trials, the favorable
results of clinical trials, the ability of the company or its
collaborators to present such data at certain conferences, and the
ability of the company to advance discussions with potential
partners to explore the development of TPST-1120. Forward-looking
statements are based on information available to Tempest
Therapeutics as of the date hereof and are not guarantees of future
performance. Actual results could differ materially from those
contained in any forward-looking statement. These and other
risks are described in greater detail in the Form 10-Q filed by
Tempest Therapeutics with the Securities and Exchange Commission on
August 10, 2023. Except as required by applicable law, Tempest
Therapeutics undertakes no obligation to revise or update any
forward-looking statement, or to make any other forward-looking
statements, whether as a result of new information, future events
or otherwise. These forward-looking statements should not be relied
upon as representing Tempest Therapeutics’ views as of any date
subsequent to the date of this press release and should not be
relied upon as prediction of future events. In light of the
foregoing, investors are urged not to rely on any forward-looking
statement in reaching any conclusion or making any investment
decision about any securities of Tempest Therapeutics.
Investor Contacts:
Sylvia WheelerWheelhouse Life Science
Advisorsswheeler@wheelhouselsa.com
Aljanae Reynolds Wheelhouse Life Science
Advisorsareynolds@wheelhouselsa.com
1 If approved by the FDA2 Ducreux, et. al., Journal of
Clinical Oncology 39, no. 15_suppl (May 20, 2021)3 Rahib, L. et al.
Projecting cancer incidence and deaths to 2030: the undexpected
burden of thyroid, liver, and pancreas cancers in the United
States. Cancer Res. 74, 2913-2921 (2014).4 World Health
Organization. Liver Cancer Factsheet. Globocan. 2020. Available at:
https://gco.iarc.fr/today/data/factsheets/cancers/11-Liver-fact-sheet.pdf.
Last accessed: April 2023.5 Llovet, J. M., Kelley, R. K.,
Villanueva, A., et al. Hepatocellular carcinoma. Nature Reviews
Disease Primers. 2021, 7(1), 6.6 Office for Health Improvement
& Disparities. Liver disease profiles: November 2021 update.
Available at:
https://www.gov.uk/government/statistics/liver-disease-profiles-november-2021-update/liver-disease-profiles-november-2021-update.
Last accessed: April 2023.7 Hack SP, Spahn J, Chen M et al. IMbrave
050: a Phase III trial of atezolizumab plus bevacizumab in
high-risk hepatocellular carcinoma after curative resection or
ablation. Future Oncology. 2020 May;16(15):975-989.8 Saito A,
Toyoda H, Kobayashi M et al. Prediction of early recurrence of
hepatocellular carcinoma after resection using digital pathology
images assessed by machine learning. Modern Pathology. 2021. 34,
417-425.
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