Sutro Biopharma Announces Oral Presentation at ASCO 2023 Featuring Data for Luveltamab Tazevibulin from the Phase 1 Dose-Expansion Study in Ovarian Cancer and the Initiation of the Phase 2/3 Pivotal Study REFRaME-O1
03 Junho 2023 - 5:00PM
Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a
clinical-stage oncology company pioneering site-specific and
novel-format antibody drug conjugates (ADCs), today announced that
results from a Phase 1 dose-expansion study of luveltamab
tazevibulin (luvelta), a novel Folate receptor alpha
(FolRα)-targeting ADC, in patients with advanced ovarian cancer
were featured in an oral presentation at the 2023 American Society
of Clinical Oncology (ASCO 2023) Annual Meeting in Chicago, IL. In
parallel, the Company continues to advance the clinical development
of luvelta and announced that sites are now open for enrollment in
REFRaME-O1, the pivotal Phase 2/3 study for patients with
platinum-resistant ovarian cancer.
Data from the Phase 1 dose-expansion study of luvelta were
presented by co-Principal Investigator, Ana Oaknin, M.D., Ph.D.,
Head of the Gynecological Tumor Unit and Attending Physician at the
Vall d’Hebron University Hospital in Barcelona and Principal
Clinical Investigator of the Gynecological Malignancies Group at
the Vall d’Hebron Institute of Oncology. Consistent with data
reported in January 2023, luvelta demonstrated substantial clinical
benefit in FolRα-selected patients, defined by Tumor Proportion
Score (TPS) of >25%, irrespective of staining intensity, which
represents approximately 80% of the advanced ovarian cancer patient
population.
When focusing on patients with a FolRα expression level above
25% (Tumor Proportion Score, or TPS >25% and regardless of
staining intensity), the efficacy outcomes exhibited a 37.5% ORR, a
median DOR of 5.5 months, and a median PFS of 6.1 months. Notably,
at the higher starting dose level of 5.2 mg/kg, these patients
experienced even higher response rates, with a 43.8% ORR, a median
DOR of 5.4 months, and a median PFS of 6.6 months. Responses were
seen in FolRα expressing patients with TPS >25%, addressing
patients who may not be eligible for other approved therapies
targeting FolRα.
“I am encouraged by the preliminary efficacy, durability, and
favorable safety profile observed in this study, which signify the
potential of luveltamab tazevibulin as a promising therapeutic
option for patients with ovarian cancer who are not well supported
by current standard of care,” commented Dr. Oaknin. “The population
of ovarian cancer patients that may benefit from treatment with
luveltamab tazevibulin represents a significant unmet medical need
globally.”
“We are excited to share these promising data in an oral
presentation at ASCO, a globally respected oncology conference,
which demonstrate the meaningful clinical benefit that luvelta may
offer to ovarian cancer patients across a broad range of
heterogeneity in FolRα-expression,” said Anne Borgman, M.D.,
Sutro’s Chief Medical Officer. “On the heels of these positive
results, we are thrilled that REFRaME, our pivotal Phase 2/3 trial,
is officially underway. From the clinical and nonclinical data
gathered, we maintain our positive outlook that luvelta could
potentially serve multiple additional indications where patients
express FolRα.”
About Luveltamab TazevibulinLuveltamab
tazevibulin, abbreviated as “luvelta” and formerly known as
STRO-002, is a FolRα-targeting antibody-drug conjugate (ADC)
designed to treat a broad range of patients with ovarian cancer,
including those with lower FolRα-expression who are not eligible
for approved treatment options targeting FolRα. Developed and
manufactured with Sutro’s cell-free XpressCF® platform, luvelta is
a homogeneous ADC with four hemiasterlin cytotoxins per antibody,
precisely positioned to efficiently deliver to the tumor while
ensuring systemic stability after dosing. Sutro recently initiated
REFRaME, a Phase 2/3 registration-directed study for patients with
platinum-resistant ovarian cancer. The company has ongoing trials
in patients with endometrial cancer and in combination with
bevacizumab in patients with ovarian cancer. The company is also
assessing the clinical path forward for CBF/GLIS2 acute myeloid
leukemia, a rare subtype of pediatric cancer, as well as non-small
cell lung cancer.
About Sutro
BiopharmaSutro Biopharma, Inc., headquartered in
South San Francisco, is a clinical-stage oncology company
pioneering site-specific and novel-format antibody drug conjugates
(ADCs). Sutro has two wholly owned ADCs in the clinic—luveltamab
tazevibulin (STRO-002 or luvelta), a folate receptor alpha
(FolRα)-targeting ADC, in clinical studies for ovarian and
endometrial cancers; and STRO-001, a CD74-targeting ADC, in
clinical studies for B-cell malignancies. Additionally, Sutro is
collaborating with Bristol Myers Squibb (BMS) on CC-99712, a
BCMA-targeting ADC in the clinic for patients with multiple
myeloma; with Merck, known as MSD outside of the United States and
Canada, on MK-1484, a selective IL-2 agonist in clinical studies as
a monotherapy and in combination with pembrolizumab for the
treatment of solid tumors; and with Astellas Pharma (Astellas) on
novel modality, immunostimulatory antibody-drug conjugates (iADCs).
Sutro’s platform technology also enabled the formation of Vaxcyte
and the innovation of VAX-24, a 24-valent pneumococcal conjugate
vaccine in clinical studies for the prevention of invasive
pneumococcal disease. Sutro’s rational design and precise protein
engineering has enabled six product candidates in the clinic.
Follow Sutro on Twitter, @Sutrobio, and at www.sutrobio.com to
learn more about our passion for changing the future of
oncology.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the “safe harbor” provisions of the Private
Securities Litigation Reform Act of 1995, including, but not
limited to, anticipated preclinical and clinical development
activities, timing of announcements of clinical results, trial
initiation, and regulatory filings, potential benefits of luvelta
and the Company’s other product candidates and platform, potential
future milestone and royalty payments, and potential market
opportunities for luvelta and the Company’s other product
candidates. All statements other than statements of historical fact
are statements that could be deemed forward-looking statements.
Although the Company believes that the expectations reflected in
such forward-looking statements are reasonable, the Company cannot
guarantee future events, results, actions, levels of activity,
performance or achievements, and the timing and results of
biotechnology development and potential regulatory approval is
inherently uncertain. Forward-looking statements are subject to
risks and uncertainties that may cause the Company’s actual
activities or results to differ significantly from those expressed
in any forward-looking statement, including risks and uncertainties
related to the Company’s ability to advance its product candidates,
the receipt and timing of potential regulatory designations,
approvals and commercialization of product candidates and the
Company’s ability to successfully leverage Fast Track designation,
the market size for the Company’s product candidates to be smaller
than anticipated, the impact of the COVID-19 pandemic on the
Company’s business, clinical trial sites, supply chain and
manufacturing facilities, the Company’s ability to maintain and
recognize the benefits of certain designations received by product
candidates, the timing and results of preclinical and clinical
trials, the Company’s ability to fund development activities and
achieve development goals, the Company’s ability to protect
intellectual property, the value of the Company’s holdings of
Vaxcyte common stock, and the Company’s commercial collaborations
with third parties and other risks and uncertainties described
under the heading “Risk Factors” in documents the Company files
from time to time with the Securities and Exchange Commission.
These forward-looking statements speak only as of the date of this
press release, and the Company undertakes no obligation to revise
or update any forward-looking statements to reflect events or
circumstances after the date hereof.
Investor ContactAnnie J. Chang Sutro
Biopharma(650) 801-5728ajchang@sutrobio.com
Media ContactAmy BonannoSolebury Strategic
Communications(914) 450-0349abonanno@soleburystrat.com
Sutro Biopharma (NASDAQ:STRO)
Gráfico Histórico do Ativo
De Ago 2024 até Set 2024
Sutro Biopharma (NASDAQ:STRO)
Gráfico Histórico do Ativo
De Set 2023 até Set 2024