Subgroup experienced efficacy and safety
consistent with overall study population
Advanced malignant PEComa tumors of
gynecologic origin accounted for more than half of the evaluable
patients enrolled in AMPECT
Additional data presented highlight
nab-sirolimus as potential approach for mTOR-driven gynecologic
cancers
LOS
ANGELES, March 17, 2024 /PRNewswire/ -- Aadi
Bioscience, Inc. (NASDAQ: AADI), a commercial-stage precision
oncology company focused on developing and commercializing
therapies for cancers with alterations in the mTOR pathway, today
announced patients in the AMPECT trial whose malignant perivascular
epithelioid cell tumor (PEComa) had gynecologic origins experienced
efficacy and safety consistent with the overall study population.
The AMPECT trial formed the basis for the FDA approval of the
company's nab-sirolimus, FYARRO®, for advanced malignant
PEComa regardless of mutational status. This new subgroup analysis
will be presented during an oral plenary at the Society of
Gynecologic Oncology (SGO) Annual Meeting in San Diego, CA on March
17, 2024.
"In AMPECT, advanced malignant PEComa tumors originating from
uterine, ovarian, pelvic or retroperitoneal sites had a response to
nab-sirolimus consistent with that of the full study
population, including overall response rate, onset and duration of
tumor response," said Thomas J.
Herzog, MD, Deputy Director, University
of Cincinnati Cancer Center. "Malignant PEComa tumors of
gynecologic or retroperitoneal origin accounted for more than half
of the evaluable patients enrolled, offering important insights
into this population and reinforcing the need for awareness and
understanding of this rare but aggressive cancer among the
gynecologic oncologist community."
Oral plenary presentation details and study highlights
include:
Title: "Response to Treatment with
nab-Sirolimus in Patients with Perivascular Epithelioid Cell
Sarcoma (PEComa) of Gynecologic or Retroperitoneal Origin: Subgroup
Analysis from AMPECT"
Presenting
Author: Thomas J. Herzog, MD
Session Title: Focused Plenary V: Rare Care: Updates in
Uncommon Cancers
Location: Ballroom 20CD
Date/Time: Sunday, March 17, 2024 – 1:45 PM to 2:45 PM
- Of the 31 patients enrolled in AMPECT, 16 had malignant PEComas
originating from uterine, ovarian, pelvic or retroperitoneal
sites
- Overall response rate to nab-sirolimus for the subgroup
was 37.5% (6/16), consistent with the overall AMPECT
population
- Subgroup responses were rapid and durable, with 1.4 months
median time to response and 36.2 months median duration of
response
- Safety profile of the subgroup was manageable and consistent
with the overall AMPECT population
Additional data presented at SGO further highlight
nab-sirolimus as a potential approach for mTOR-driven
gynecologic cancers. These presentations include a real-world study
characterizing TSC1 and TSC2 inactivating alterations
in patients with advanced gynecologic cancers; trial-in-progress
updates for the ongoing, tumor agnostic, registration-intended
PRECISION1 trial; and a Phase 2 study of nab-sirolimus in
combination with letrozole for advanced or recurrent
endometrioid-type endometrial cancer (EEC).
"Overactivation of the mTOR pathway has been implicated in
gynecological cancers," said Loretta
Itri, MD, Chief Medical Officer at Aadi.
"nab-Sirolimus is a nanoparticle albumin-bound (nab) mTOR
inhibitor under investigation in TSC1- and
TSC2-mutated tumors as well as other mTOR-driven tumors. We
are diligently continuing to explore the potential of
nab-sirolimus for this patient community in need of new
therapies."
Poster presentation details and highlights include:
Title: "Analysis of inactivating TSC1 and TSC2
alterations in a real-world patient population with advanced
gynecological cancers in the Foundation Medicine genomic
database"
Presenting Author: Lauren E.
Dockery, MD, MS
Session Title: Poster Session 1
Location: Exhibit Hall (Hall GH)
Poster Number: 1176
Date/Time: Sunday, March 17, 2024 – 1:15 PM to 2:45 PM
- Registration-directed PRECISION1 study is enrolling patients
with solid tumors harboring TSC1 and/or TSC2
inactivating alterations
- In a large real-world database of patients with advanced
cancer, 1,342 (2.4%) of the 54,911 patients with gynecological
cancers harbored at least one inactivating alteration in
TSC1 or TSC2
- TSC1 and/or TSC2 inactivating alterations were
present in 3.6% of endometrial cancers, 2.0% of ovarian cancers and
1.5% of cervical cancers
Title: "nab-Sirolimus Plus Letrozole in
Advanced or Recurrent Endometrioid Endometrial Cancer: A Phase 2,
Open-Label, Single-Arm, Prospective, Multi-Center
Study"
Presenting Author: Lauren E.
Dockery, MD, MS
Session Title: Poster Session 2
Location: Exhibit Hall (Hall GH)
Poster Number: 2127
Date/Time: Monday, March 18, 2024 – 11:45 AM to 12:45 PM
- This ongoing phase 2, open-label, single-arm, multicenter study
is evaluating nab-sirolimus in combination with letrozole
for the treatment of patients with advanced or recurrent EEC
- Prior clinical studies with mTOR inhibitors and endocrine
therapy have yielded promising results in EEC
Title: "nab-Sirolimus for Malignant Solid
Tumors Harboring Pathogenic Inactivating Alterations in TSC1 and
TSC2 in a Phase 2, Multicenter, Open-Label Tumor-Agnostic Trial:
PRECISION 1"
Presenting Author: Debra L.
Richardson, MD
Session Title: Poster Session 2
Location: Exhibit Hall (Hall GH)
Poster Number: 2126
Date/Time: Monday, March 18, 2024 – 11:45 AM to 12:45 PM
- TSC1 and/or TSC2 inactivating
alterations have been observed in patients with gynecological
cancers with a frequency of up to 5.0% in endometrial cancer, 2.2%
in ovarian cancer and 1.5% in cervical cancer
About Aadi Bioscience
Aadi is a
commercial-stage precision oncology company focused on the
development and commercialization of therapies for cancers with
alterations in the mTOR pathway, a key regulator of cell growth and
cancer progression. To unlock the full potential of mTOR
inhibition, Aadi uniquely combines nanoparticle albumin-bound
(nab) technology with the potent mTOR inhibitor, sirolimus.
Aadi received FDA approval and commercializes FYARRO® for the
treatment of adult patients with locally advanced unresectable or
metastatic malignant perivascular epithelioid cell tumor
(PEComa).
Aadi is exploring nab-sirolimus in PRECISION1, a Phase 2
tumor-agnostic registration-intended trial in mTOR inhibitor-naïve
malignant solid tumors harboring TSC1 or TSC2
inactivating alterations. Aadi is also exploring
nab-sirolimus in two single-indication Phase 2 trials for
difficult-to-treat mTOR-driven cancers: neuroendocrine tumors
(NETs), and advanced or recurrent endometrioid-type endometrial
cancer (EEC) in combination with letrozole. More information on the
Company's development pipeline is available on the Aadi website at
www.aadibio.com and connect with us on Twitter and LinkedIn.
Forward-Looking Statements
This press release
contains certain forward-looking statements regarding the business
of Aadi Bioscience that are not a description of historical facts
within the meaning of the Private Securities Litigation Reform Act
of 1995. Forward-looking statements are based on the Company's
current beliefs and expectations and may include, but are not
limited to, statements relating to: expectations regarding the
beneficial characteristics, safety, efficacy and therapeutic
effects of FYARRO; expectations regarding the clinical responses
and safety profile, regulatory approval and commercialization, and
the sufficiency of the Company's existing capital resources and the
expected timeframe to fund the Company's future operating expenses
and capital expenditure requirements. Actual results could differ
materially from those anticipated in such forward-looking
statements as a result of these risks and uncertainties, which
include, without limitation, those associated with the
uncertainties associated with the clinical development and
regulatory approval of FYARRO in additional indications; the risk
that interim or subgroup analysis results of clinical trials may
not be reproduced and do not necessarily predict final results; the
risk that one or more of the clinical outcomes may materially
change as patient enrollment continues, following more
comprehensive reviews of the data and as more patient data become
available; the risk that unforeseen adverse reactions or side
effects may occur in the course of commercializing, developing and
testing FYARRO; and risks related to Aadi's estimates regarding
future expenses, capital requirements and need for additional
financing.
Additional risks and uncertainties that could cause actual
outcomes and results to differ materially from those contemplated
by the forward-looking statements are included in the Company's
Annual Report on Form 10-K for the fiscal year ended December 31, 2023, including under the caption
"Item 1A. Risk Factors," and elsewhere in Aadi's reports and other
documents that Aadi has filed, or will file, with the SEC from time
to time and available at www.sec.gov.
All forward-looking statements in this press release are current
only as of the date hereof and, except as required by applicable
law, Aadi 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. All forward-looking statements are qualified in their
entirety by this cautionary statement. This cautionary statement is
made under the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995.
Contact:
IR@aadibio.com
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