Starton Therapeutics Announces 100% Partial Response or Better in Multiple Myeloma Patients in Interim, Top-line Data from STAR-LLD Phase 1b Clinical Trial
June 21 2024 - 8:05AM
Starton Therapeutics Inc. (“Starton” or the “Company”), a
clinical-stage biotechnology company transforming standard-of-care
therapies with proprietary dermal technologies, announced today
positive interim top-line data from its low-dose lenalidomide
STAR-LLD Phase 1b clinical trial in multiple myeloma (MM). The
study, designed to assess the safety, pharmacokinetics, and
efficacy of the Company’s STAR-LLD in combination with
dexamethasone and bortezomib (Velcade®), met the primary objective
of safety and tolerability while being administered by continuous
subcutaneous (SC) infusion. All six patients achieved a partial
response (PR) or better within 1-3 cycles.
“These interim results are encouraging,” stated Dr.
Jamie Oliver, Starton’s Chief Medical Officer. “To date,
lenalidomide is a cornerstone in treating MM. As a standard of
care, Revlimid® is widely used due to its effectiveness in
combination with other therapies. However, its toxicity profile is
unbearable for some, leaving a notable percentage of patients’
intolerant to lenalidomide. STAR-LLD is demonstrating lower
toxicity at therapeutic doses, which could potentially improve
lenalidomide’s use in MM.”
“Lenalidomide intolerance adversely affects
treatment efficacy and overall survival, often leading to dose
modifications or treatment discontinuation. By successfully
demonstrating continuous delivery at a tolerable dose, we are
directly addressing the needs of patients and their loved ones,”
stated Pedro Lichtinger, Starton’s Chairman and CEO.
Tolerance measures a patient's ability to endure
minimal adverse effects from a certain drug. Severe intolerance may
lead to discontinuity of treatment. The most common side effects
associated with Revlimid® during continuous maintenance treatment
and contributing to intolerance include neutropenia (79%),
thrombocytopenia (72%), anemia (21%), and gastrointestinal issues
(40%). The hematologic adverse events lead to treatment
interruptions in approximately 30% of patients. By contrast,
Starton’s Phase 1b study resulted in no grade 3 or greater adverse
events of neutropenia or thrombocytopenia. Although diarrhea was
reported by 33% of the patients in Starton’s Phase 1b study at
grades 1 and 2 adverse events, this was favorable compared to oral
Revlimid®, where diarrhea was observed in approximately 50% or more
patients, of which close to 20% of those patients experienced
grades 3 or 4 toxicity. Half of the Phase 1b patients reported a
confined rash at the injection site, and one patient reported a
rash with grade 3, which was treated. Nausea and fatigue were
reported at grades 1 and 2. The majority of events reported in the
study were not drug-related.
The Company will prepare a summary of data on
safety and activity for the U.S. Food and Drug Administration (FDA)
while patients continue treatment for efficacy endpoints. Phase 2
studies in MM and chronic lymphocytic leukemia (CLL) are planned
for 2025.
About STAR-LLD
STAR-LLD is a continuous delivery lenalidomide
(LLD) in development to expand and replace the standard of care for
the most common blood cancers, multiple myeloma (MM), and chronic
lymphocytic leukemia (CLL). A preclinical proof-of-concept study
for STAR-LLD demonstrated that MM tumors caused by human myeloma
cells grew 25-fold if untreated, grew five-fold when treated with
daily lenalidomide, and shrank by 80% with STAR-LLD over a single
28-day cycle. The study also showed a 100% overall response rate
(ORR) using continuous delivery LLD and 20% of animals in this
cohort were tumor-free after 100 days, compared to a 0% ORR in
animals treated with a 70% higher dose of lenalidomide given in
single daily doses. In addition, a Phase 1 bioavailability study in
healthy men comparing STAR-LLD to Revlimid® demonstrated the drug
is well tolerated and is >91% bioavailable by the subcutaneous
route. It was also observed that the Cmax is <90% lower with
STAR-LLD than with oral Revlimid®.
About Starton Therapeutics
Starton Therapeutics is a clinical-stage
biotechnology platform company focused on transforming
standard-of-care therapies with proprietary continuous delivery
technology, so people with cancer can receive continuous treatment
to live better, longer. Starton’s proprietary transdermal
technology is intended to increase the efficacy of approved drugs,
make them more tolerable, and expand their potential use. To learn
more, visit www.startontx.com.
Forward Looking Statements
All statements other than statements of historical
facts included in this press release, including, without
limitation, statements regarding our plans and objectives for
future operations and expectations about current and future
clinical trials, constitute “forward-looking statements.”
Forward-looking statements are subject to numerous conditions and
known and unknown risks and uncertainties that could cause our
actual results or events to differ materially and adversely from
those included within the forward-looking statements. Readers are
cautioned not to place undue reliance on these forward-looking
statements and, except as required by law, the Company undertakes
no obligation to disclose any revision to these forward-looking
statements whether as a result of new information, future events,
or otherwise.
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