589 0 Kommentare New Data Presented from Oncopeptides' Pivotal Phase 2 HORIZON Trial Evaluating Melflufen in Relapsed/Refractory Multiple Myeloma at 24th EHA Congress - Seite 2

"The number of patients with resistant myeloma characterized by extra-medullary disease and high-risk cytogenetics is increasing, despite recent advances, and there is a real need for additional treatment options based on new mechanisms of action. Melflufen continues to demonstrate promising activity and manageable toxicity in the relapsed and refractory setting, and in particular amongst patients who are triple-class refractory " said Paul Richardson, MD, the RJ Corman Professor of Medicine at Harvard Medical School and Director of Clinical Research at the Jerome Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute, Boston, USA.

About the OP-106 HORIZON study
Patient recruitment in the HORIZON study is ongoing. The interim data presented at EHA is based on a data cut-off dated May 6th 2019 with 121 patients treated. 108 patients had recivied two or more cycles of treatment. The goal is to include 150 patients in the study. The patients in the study are refractory to pomalidomide and/or daratumumab after failing on immunomodulatory drugs (IMiDs) and proteasome inhibitors (PIs).

More information can be found at: https://clinicaltrials.gov/ct2/show/NCT02963493?term=melflufen&rank=2

Summary of the OP-106 HORIZON interim data
The study continues to develop positively in this heavily pretreated patient group. Melflufen continues to demonstrate promising activity in patients that have stopped responding to lenalidomide and PI based regimens and subsequently become resistant to salvage therapy based on daratumumab and/or pomalidomide.

The median age of the patients was 64 years. 62% of patients in the study had high-risk cytogenetics, 29% of patients were ISS stage III and 60% of the patients had extramedullary disease (EMD). The median number of prior lines of therapy was five and the median time since initial diagnosis was 6.2 years.

All patients in the study were investigator assessed as non-responsive or non-tolerant to IMiDs and PIs.

91% of patients were double class refractory (IMiD + PI) and 79% anti-CD38 mAb refractory. 74% of the patients were triple class (IMiD + PI + Anti-CD38 mAb) refractory and 59% were alkylator refractory. 98% of the patients were refractory in last line of therapy.

Efficacy
Analysis of the interim efficacy results showed an ORR of 28% and that 86% of the patients achieved disease stabilization (SD or better), see table below.