The pharmaceutical company Oncopeptides has announced that the first patient has been enrolled in the OP-201 study. This is an open-label, phase 1/2 study to evaluate melflufen and dexamethasone in AL amyloidosis patients, following at least one prior line of therapy. This is the first study to explore the effect of melflufen outside of myeloma.
This study is based on the pre-clinical data presented at American Society of Hematology (ASH) Annual Meeting in December of 2019. The study will enrol approximately 40 patients. The primary endpoints in the phase 1 part are safety and tolerability, and in the phase 2 part of the trial will be Overall Response Rate (ORR).
About AL amyloidosis
AL amyloidosis (also called light chain amyloidosis) is the most prevalent type of amyloidosis with an estimated incidence of 9 cases per million inhabitants/year. However, it is thought that misdiagnosis due to the clinical scenarios that mimic this condition may mean the true figure is higher. Learn more about AL amyloidosis here.