Oncopeptides presents clinical results from Phase I/II study of melflufen and dexamethasone in patients with relapsed and relapsed refractory multiple myeloma

17 June 2015  •  Author: Victoria White

Oncopeptides has presented clinical results from an ongoing Phase I/II study of melflufen in combination with dexamethasone in patients with relapsed and relapsed refractory multiple myeloma.


The results, presented at the European Haematology Association meeting, showed an overall response rate of 52% and clinical benefit rate of 67% in efficacy evaluable patients. At the date of analysis, the median progression-free survival was 7.6 months in the total population with 56% of the patients still without disease progression. 90% of the patients were refractory patients, 67% of patients were refractory to last line of treatment and 48% of patients were double refractory to both IMiDs and proteasome inhibitors. The response rates were similar across the different patient refractory status groups (single, double and triple refractory patients).

Melflufen 40 mg was well tolerated and the few treatment related serious adverse events reported in this late stage patient population, 3 out of 29 patients, suggest that the primary toxicities of thrombocytopenia and neutropenia are clinically manageable.

Melflufen triggers rapid, robust and irreversible DNA damage

The results are from a clinical trial being carried out across four centres in Europe (Sweden, Italy, the Netherlands and Denmark) and two in the USA (Boston, MA and Chapel Hill, NC), the results support Oncopeptides’ belief that melflufen has the potential to provide an alternative when conventional therapies have failed in relapsed and relapsed-refractory multiple myeloma.

Melflufen is a peptidase-targeted therapy and a potent antiangiogenic compound. It triggers rapid, robust, and irreversible DNA damage and exerts it cytotoxicity through alkylation of DNA.

CEO, Jakob Lindberg commented, “The trial results on the activity and safety of melflufen in combination with dexamethasone are most encouraging and I am looking forward to building upon these findings as we continue with the melflufen clinical programme. There is a real need for more effective therapies to treat refractory multiple myeloma and I believe that melflufen has the potential to deliver better treatment of the disease.”

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