Oncopeptides AB (publ) announced 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 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.