Oncopeptides publishes two articles with results from ANCHOR and LIGHTHOUSE studies in Haematologica
Stockholm – September 4, 2023 – Oncopeptides AB (publ), a biotech company focused on difficult-to-treat cancers, today announces that two new articles with scientific data on melflufen, marketed in Europe as Pepaxti, has been published in Haematologica, a publication reporting on important findings in basic, clinical and translational research within hematology. The published data from two studies, ANCHOR and LIGHTHOUSE, provides additional scientific support for the clinical benefit of melflufen and dexamethasone in combination with daratumumab or bortezomib in relapsed refractory multiple myeloma (RRMM).
The ANCHOR study is a phase 1/2 open label multicenter study evaluating the safety and efficacy of melflufen plus dexamethasone in combination with either daratumumab or bortezomib in patients with RRMM. The study started in April 2018 with 56 patients enrolled. Considering the totality of the data, melflufen 30 mg was established as the recommended dose for future combination studies in RRMM. The full article can be found here.
The LIGHTHOUSE study assessed melflufen plus daratumumab and dexamethasone versus daratumumab with supporting dexamethasone in patients with RRMM with disease refractory to an immunomodulatory agent and a proteasome inhibitor or who had received ≥3 prior lines of therapy including an immunomodulatory agent and a proteasome inhibitor. The study included 54 patients and met its primary endpoint despite being prematurely terminated. It concludes that melflufen plus daratumumab and dexamethasone demonstrated superior progression free survival (HR 0.18 [0.05-0.65], p=0.0032). OS data was immature (HR 0.47 [0.09-2.57], p=0.37). The safety profile was comparable to previously published melflufen studies. The full article can be found here.
“The ANCHOR and LIGHTHOUSE trials provide further evidence of the efficacy of melflufen in relapsed refractory multiple myeloma,” says Stefan Norin, Chief Medical Officer at Oncopeptides. “As melflufen continues its journey as an increasingly important treatment option for patients in Europe, the comprehensive data provided from these two studies provides valuable data for the understanding of combination therapy including melflufen.”
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David Augustsson, Director of Corporate Affairs, Oncopeptides AB (publ)
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Oncopeptides is a biotech company focused on research, development, and commercialization of therapies for difficult-to-treat hematological diseases. The company uses its proprietary Peptide Drug Candidate platform (PDC) to develop compounds that rapidly and selectively deliver cytotoxic agents into cancer cells.
Pepaxti® (melphalan flufenamide, also called melflufen) has been granted Marketing Authorization, in the European Union, the EEA-countries Iceland, Lichtenstein and Norway, as well as in the UK. Pepaxti is indicated in combination with dexamethasone for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy. For patients with a prior autologous stem cell transplantation, the time to progression should be at least 3 years from transplantation. Melflufen has been granted accelerated approval in the US under the trade name Pepaxto®. The drug is currently not marketed in the US.
Oncopeptides is developing several new compounds based on its proprietary technology platforms and is listed on the Small Cap segment on Nasdaq Stockholm with the ticker ONCO. For more information see: www.oncopeptides.com.