Our clinical studies

The purpose of our clinical development program is to establish melflufen as a potential cornerstone in the treatment of relapsed refractory multiple myeloma.

Oncopeptides PDC platform

Clinical Development

The clinical development of targeted therapies for difficult-to-treat hematological diseases and malignancies are based on our peptide-drug conjugate platform, PDC. We are focusing on the late-stage development of our lead product candidate melflufen in multiple myeloma.

Read more

Regulatory strategy

The US FDA is currently doing a priority review of Oncopeptides submission of a New Drug Application for accelerated approval of melflufen in combination with dexamethasone in triple-class refractory multiple myeloma. 

Read more

O-12-M1

O-12-M1 is a completed international, open-label phase 1/2 study to establish the dose of melflufen in combination with dexamethasone and investigate the treatment response in patients with relapsed refractory multiple myeloma, who were refractory to the last line of therapy.

Read more

HORIZON

The phase 2 HORIZON study is a pivotal, single-arm study, evaluating the safety and efficacy of melflufen in combination with dexamethasone in patients with relapsed refractory multiple myeloma.

Read more

OCEAN

The phase 3 OCEAN study is a randomized, head-to-head study, evaluating the efficacy and safety of melflufen and dexamethasone, versus pomalidomide and dexamethasone in patients with relapsed refractory multiple myeloma.

Read more

ANCHOR

ANCHOR 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 relapsed refractory multiple myeloma.

Read more

BRIDGE

The phase 2 BRIDGE study is an open-label, single-arm study, designed to evaluate the pharmacokinetics, safety and efficacy of melflufen in combination with dexamethasone in multiple myeloma patients with reduced renal function.

Read more

ASCENT

The phase 1/2 ASCENT study is the first study with melflufen outside multiple myeloma. The ASCENT study is an open-label study with melflufen and dexamethasone in patients with AL-amyloidosis, who have undergone at least one previous line of therapy.

Read more

PORT

The phase 2 PORT study is an open-label, randomized, cross-over study which compares safety, tolerability and efficacy, of peripheral or central intravenous administration of melflufen in combination with dexamethasone in patients with relapsed refractory multiple myeloma.

Read more

LIGHTHOUSE

The phase 3 LIGHTHOUSE study is a randomized, open-label, phase 3 study of melflufen and dexamethasone in combination with daratumumab compared to daratumumab alone in patients with relapsed and refractory multiple myeloma.

Read more