New Data Presented from Oncopeptides' Pivotal Phase 2 HORIZON Trial Evaluating Melflufen in Relapsed/Refractory Multiple Myeloma at 24th EHA Congress - Seite 3
of treatment data at time of data cutoff May 6th, 2019.
CBR, clinical benefit rate; CR, complete response; MR, minimal response; ORR, overall response rate;
PD, progressive disease; PR, partial response; sCR, stringent CR; SD, stable disease; VGPR, very good PR.
For patients with extra-medullary disease the ORR was 29% as described in the table below.
Safety and tolerability
At time of data cut-off, treatment-related SAEs occurred in 20% of patients, most commonly febrile neutropenia (5%) and thrombocytopenia (2%). The overall incidence of nonhematologic AEs was
low.
Discontinuation rate because of AEs was 20%. There were no treatment-related deaths. Six patients (6%) experienced treatment-related bleeding: grade 1 in four patients, grade 3 in two patients.
For further information, please contact:
Jakob Lindberg, CEO of Oncopeptides
E-mail: jakob.lindberg@oncopeptides.com
Telephone: +46 8 615 20 40
Rein Piir, Head of Investor Relations at Oncopeptides
E-mail: rein.piir@oncopeptides.com
Cell phone: +46 70 853 72 92
The information in the press release is information that Oncopeptides is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person above, on June 16, 2019 at 08.45 (CET).
About melflufen
Melflufen is a lipophilic peptide-conjugated alkylator that rapidly delivers a highly cytotoxic payload into myeloma cells through peptidase activity. It belongs to the novel class Peptidase
Enhanced Cytotoxics (PEnC), which is a family of lipophilic peptides that exhibit increased activity via peptidase cleavage and have the potential to treat many cancers. Peptidases play a key role
in protein homeostasis and feature in cellular processes such as cell-cycle progression and programmed cell death. Melflufen is rapidly taken up by myeloma cells due to its high lipophilicity and
immediately cleaved by peptidases to deliver an entrapped hydrophilic alkylator payload. In vitro, melflufen is 50-fold more potent in myeloma cells than the alkylator payload itself due to the
peptidase cleavage, and induces irreversible DNA damage and apoptosis. Melflufen displays cytotoxic activity against myeloma cell lines resistant to other treatments, including alkylators, and has
also demonstrated inhibition of DNA repair induction and angiogenesis in preclinical studies.