Spectrum Pharmaceuticals SPPI, a biotechnology company with fully
integrated commercial and drug development operations and a primary focus in
hematology and oncology, today announced positive results from the BELIEF
trial, a pivotal, single-arm study of belinostat in patients with relapsed or
refractory peripheral T-cell lymphoma (R/R PTCL) after failure of ≥1 prior
systemic therapies. Data presented at an oral session at ASCO demonstrated the
clinical activity of belinostat, a novel pan-histone deacetylase inhibitor, in
treating patients (N=129) with R/R PTCL with:
* Overall Response Rate (ORR) of 26% in heavily pretreated patients
* Median Duration of Response (DoR) of 13.6 months by International Working
Group (IWG) criteria
* Anti-tumor activity demonstrated in poor prognosis PTCL subtypes including
angioimmunoblastic T-cell lymphoma (AITL) with a ORR of 46%, patients with
poor marrow reserves and low platelet counts (<100,000 per mcL), and
patients with previous autologous and allogeneic stem cell transplants
* Well tolerated with an acceptable safety profile and >98% dose intensity
that could potentially allow for novel combination chemotherapies
“These data are very encouraging and demonstrate the potential clinical
activity and safety of belinostat as a single agent in the treatment of
patients with relapsed or refractory PTCL,” said Rajesh C. Shrotriya, MD,
Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals.
“Despite the recent approvals of new treatments for R/R PTCL, there remains an
unmet medical need with approximately 70% of patients failing current
therapies, so clearly these patients need alternative effective treatment
options. We are excited that Spectrum is on track to file an NDA for
belinostat for this indication in 2013.”
“In this study, Belinostat demonstrated important clinical efficacy in poor
prognosis relapsed and refractory PTCL patients,” said Dr. Owen A. O'Connor,
Professor of Medical and Experimental Therapeutics and Director of the Center
for Lymphoid Malignancies at the Columbia University Medical Center College of
Physicians and Surgeons, one of the lead investigators in the belinostat
study. “Its safety profile and tolerability in patients with poor marrow
reserve makes it an ideal candidate for the development of new combination
treatment paradigms for PTCL.”
The BELIEF study enrolled 129 PTCL patients refractory to or who had failed at
least one prior systemic therapy; diagnosis was confirmed by Central Pathology
Review. Patients received belinostat at 1,000 mg/m^2 as a 30 minute
intravenous infusion on days 1 thru 5 every 21 days. The primary study end
point was the overall response rate (ORR) as assessed by an Independent Review
Committee.
Single-agent belinostat was shown to induce complete and partial responses
even in poor prognosis R/R PTCL subtypes, e.g., angioimmunoblastic T-cell
lymphoma (AITL) and ALK (-) anaplastic large cell lymphoma. Overall,
belinostat was well-tolerated, requiring minimal dose reductions or dose
delays leading to the successful delivery of high dose intensity treatment to
heavily pretreated patients.
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