New Data Presented from Oncopeptides' Pivotal Phase 2 HORIZON Trial Evaluating Melflufen in Relapsed/Refractory Multiple Myeloma at 24th EHA Congress
STOCKHOLM, June 16, 2019 /PRNewswire/ -- Oncopeptides AB (Nasdaq Stockholm: ONCO) announced today updated interim efficacy and safety data from the ongoing, pivotal Phase 2 HORIZON trial. The oral presentation was included in the "Novel strategies in multiple myeloma" session and was led by Professor Paul G. Richardson, Professor of Medicine at Harvard Medical School and Clinical Program Leader, Director of Clinical Research at the Jerome Lipper Multiple Myeloma Center Dana-Farber Cancer Institute in Boston, Massachusetts, USA.
The presentation will be available on the company webpage under:
www.oncopeptides.com / Investors & media / Presentations / 2019 EHA
Comment from CEO Jakob Lindberg
"HORIZON is an all-comer trial for patients with very advanced multiple myeloma. A majority of patients have extra medullary disease (EMD) as well as high-risk cytogenetics. Notably patients with EMD at relapse have limited response from treatment in clinical trials even in the era of modern therapies. In light of this patient population, the response rate of 28% coupled with the manageable side effect profile in HORIZON is very encouraging and indicates that melflufen plus dexamethasone can offer these patients a reasonable treatment alternative. These data form the basis of the upcoming New Drug Application (NDA) submission that we are currently preparing for accelerated approval of melflufen for the treatment of patients with triple-class refractory multiple myeloma" said Jakob Lindberg, CEO of Oncopeptides.
Overall Conclusions – HORIZON Presentation
- At the time for the data cut-off, May 6th, 35 out of the 121 patients included were still on treatment.
- The Overall Response Rate (ORR) was 28% and the Clinical Benefit Rate (CBR) was 40%, 36% of patients had receved 3+ treatment regimens over the last 12 months.
- Extra-medullary disease patients had an ORR of 29%.
- The majority of patients 86%, achieved disease stabilization (SD or better)
- The median Progression Free Survival (PFS) was 4.0 months in the ongoing study.
- Treatment was generally well tolerated with manageable toxicity, nonhematologic AEs were infrequent and the rate of discontinuation due to AEs was low.
Comment from Professor Paul G. Richardson