New Interim Data in RRMM Patients With Extramedullary Disease from the Pivotal Phase 2 Horizon-study Presented at International Myeloma Workshop
New Interim Data in RRMM Patients With Extramedullary Disease from the Pivotal Phase 2 Horizon-study Presented at International Myeloma Workshop |
[15-September-2019] |
STOCKHOLM, Sept. 15, 2019 /PRNewswire/ -- Oncopeptides AB (Nasdaq Stockholm: ONCO) announced today updated interim efficacy and safety data from the ongoing pivotal Phase 2 study, HORIZON, at the 17th International Myeloma Workshop (IMW) meeting in Boston, Massachusetts, USA. The data focused on patients with extramedullary disease (EMD) and was presented in an oral presentation by Professor Paul G. Richardson. Oncopeptides will host a conference call to review this data on Monday, September 16, 2019, at. 08.30 (CET). The results presented at IMW 2019 by Professor Paul G Richardson in the plenary session "Late Breaking Abstracts" under the title: Activity of Melflufen in RRMM Patients with Extramedullary Disease in the Phase 2 Study (OP-106 HORIZON) – Promising Results in a High-Risk Population, are based on a data cut in the HORIZON study dated July 30, 2019 when 136 patients were treated compared to previously reported data including 121 patients. Based on literature, HORIZON represents the largest clinical cohort to date of myeloma patients with extra medullary disease (EMD). Relapsed-refractory multiple myeloma (RRMM) patients with extramedullary disease (EMD) is a very difficult to treat patient population. In recent single-agent studies (with or without steroids) including RRMM patients with EMD have shown overall response rates (ORR) between 0 - 17%. Only daratumumab has shown any relevant clinical activity with a response rate of 17% in daratumumab naïve myeloma patients with EMD. In the HORIZON study, an overall response rate of 23% was achieved with treatment with melflfufen and dexamethasone in RRMM patients with EMD. These patients were mainly penta refractory (had undergone at least five prior treatments and were resistant to at least one proteasome inhibitor, one IMiD, and anti-CD38 treatment). The EMD patients who responded to the treatment had a median survival (OS) of 18.5 months compared to a median survival of 5.1 months for the EMD patients who did not respond to treatment. The difference observed suggests a clear clinical benefit for these patients. Professor Paul G Richardson comments "In my view, given the relative lack of therapeutic alternatives for these patients, moving rapidly into melflufen-based combination strategies in patients with extramedullary disease, as well as exploring earlier lines of therapy, should be the next priority", said 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. Overall Conclusions From the Presentation
The full presentation from IMW is available on the company's website under: Conference call for investors, analysts and the media Phone numbers for participants from: The information in the press release is information that Oncopeptides is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person above, on September 15, 2019 at 14.30 (CET). About the OP-106 HORIZON study Oncopeptides has initiated preparations for submitting a New Drug Application (NDA) for accelerated approval of melflufen in the US based on the available HORIZON data. The detailed plan for the filing process is still under development, but Oncopeptides currently targets to submit the application to FDA during the first quarter of 2020. This could then lead to the first melflufen market approval in the US in 2020. More information can be found at: https://clinicaltrials.gov/ct2/show/NCT02963493?term=melflufen&rank=2 About Melflufen About Oncopeptides For more information please visit www.oncopeptides.com. For further information, please contact: Rein Piir, Head of Investor Relations at Oncopeptides
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SOURCE Oncopeptides AB | ||||
Company Codes: Stockholm:ONCO, ISIN:SE0009414576, RICS:ONCO.ST |
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