Acceleron Presents Encouraging Response Rates & Progression-Free Survival Data in Patients with Advanced Renal Cell Carcinoma...
February 28 2015 - 10:00AM
Business Wire
Acceleron Pharma Inc. (NASDAQ:XLRN), a clinical stage
biopharmaceutical company focused on the discovery, development and
commercialization of novel therapeutic candidates that regulate
cellular growth and repair, today reported new preliminary data
from the DART study, an ongoing phase 2 clinical trial of
dalantercept in patients with advanced renal cell carcinoma (RCC).
The preliminary data from part 1 of the DART study were presented
in an oral session at the American Society of Clinical Oncology
(ASCO) 2015 Genitourinary Cancers Symposium held in Orlando,
Florida on February 28, 2015.
“These promising response rates and progression-free survival
data suggest that the dual angiogenesis blockade of ALK1 and VEGFR
signaling with dalantercept and axitinib may provide additive
efficacy compared to VEGFR inhibitor therapy alone,” said Matthew
Sherman, M.D., Chief Medical Officer of Acceleron.
“The results from part 1 of this study provide encouraging
evidence of the safety and activity of this combination of two
distinct anti-angiogenic agents in previously treated patients with
advanced RCC,” said Martin H. Voss, M.D., medical oncologist at
Memorial Sloan Kettering Cancer Center and lead investigator for
the trial. “We look forward to building on these results in the
randomized part 2 of the ongoing DART trial.”
In the DART trial, dalantercept, an activin receptor-like kinase
1 (ALK1) inhibitor, is being evaluated in combination with Inlyta®
(axitinib), a VEGFR tyrosine kinase inhibitor, in patients with
advanced RCC who have progressed on one prior VEGFR tyrosine kinase
inhibitor and no more than three prior treatments.
Key preliminary data from part 1 of the DART study (open-label,
dose escalation and expansion cohorts):
- Three cohorts each received
dalantercept (0.6, 0.9, or 1.2 mg/kg) subcutaneously once every
three weeks and axitinib 5 mg orally twice a day for each 21 day
cycle. The 0.9 and 1.2 mg/kg dose levels were expanded.
- Response rates (RECIST v1.1) of the
combination of dalantercept and axitinib:
- Objective response rate of 25.0% (7
partial responses of 28 patients)
- Stable disease rate of 60.7% (17 of 28
patients)
- Disease control rate at 6 months of
57.1% (16 of 28 patients)
- The preliminary median progression-free
survival (PFS) of dalantercept plus axitinib is 8.3 months across
all dose levels tested in part 1.
- The median PFS of the 0.9 mg/kg cohort
has not yet been reached.
- The most common treatment emergent
adverse events were fatigue, diarrhea, dysphonia and peripheral
edema. There were no grade 4 or 5 related adverse events.
- Common adverse reactions expected with
axitinib such as diarrhea, hypertension, palmar-plantar
erythrodysesthesia, and proteinuria did not increase in incidence
or severity when combined with dalantercept.
For reference, in the axitinib AXIS phase 3 study, in the large
subgroup of sunitinib-refractory patients treated with single-agent
axitinib, the objective response rate was 11.3% and the median
progression-free survival was 4.8 months.
Key details for the ongoing part 2 of the DART study
(randomized, double-blind):
- Part 2 of the DART study is open for
enrollment of patients who have received one VEGFR TKI and may have
also received 1 prior mTOR inhibitor and/or any number of prior
immune therapies.
- Based on the results from Part 1,
dalantercept 0.9 mg/kg was selected as the dose level in Part 2 of
the DART study.
The poster and presentation slides are available on Acceleron’s
website (www.acceleronpharma.com) under the Publications
section.
About the DART Phase 2 Clinical Trial in RCC
The phase 2 DART clinical trial is a two-part study in patients
with advanced renal cell carcinoma. Part 1 is a dose-escalation
study of dalantercept in combination with axitinib to evaluate the
safety and tolerability of the combination in patients whose
disease has progressed following one to three lines of prior
therapy. Part 2 is a randomized, double-blind study of 130 patients
with advanced renal cell carcinoma who have progressed following
treatment with a VEGF receptor tyrosine kinase inhibitor. Patients
may have also received prior mTOR therapy and/or immunotherapy. The
objective of the study is to determine whether treatment with
dalantercept in combination with axitinib prolongs progression-free
survival compared to treatment with placebo plus axitinib. For
additional information on this clinical trial, please visit
www.clinicaltrials.gov, identifier NCT01727336.
About Dalantercept
Dalantercept (ACE-041) is an investigational protein therapeutic
that inhibits angiogenesis by preventing BMP9, a protein in the
TGF-β superfamily, from interacting with activin receptor-like
kinase 1 (ALK1), a cell-surface receptor found on proliferating
vascular endothelial cells. Dalantercept inhibits ALK1 signaling,
which is required for the development of mature, functional
vasculature.
About Acceleron
Acceleron is a clinical stage biopharmaceutical company focused
on the discovery, development and commercialization of novel
protein therapeutics for cancer and rare diseases. The company is a
leader in understanding the biology of the Transforming Growth
Factor-Beta (TGF-β) protein superfamily, a large and diverse group
of molecules that are key regulators in the growth and repair of
tissues throughout the human body, and in targeting these pathways
to develop important new medicines. Acceleron has built a highly
productive R&D platform that has generated innovative clinical
and preclinical protein therapeutic candidates with novel
mechanisms of action. These protein therapeutic candidates have the
potential to significantly improve clinical outcomes for patients
with cancer and rare diseases.
For more information, please visit www.acceleronpharma.com.
Acceleron PharmaSteven Ertel, 617-649-9234Senior Vice President
and Chief Business OfficerorMedia:Suda Communications LLCMaureen L.
Suda, 585-387-9248
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