Clinical Development - Oncopeptides

Clinical program

The clinical development of targeted therapies for difficult-to-treat hematological diseases and malignancies is based on our peptide-drug conjugate platform, PDC.

In November 2021, Oncopeptides decided to refocus the clinical development program with melflufen and reduce the number of studies to support the marketing authorization process in Europe, and strengthen the company´s cash position.

OCEAN study continues with long-term follow-up and documentation. The study is planned to close in Q1, 2023.

The PORT and BRIDGE studies have been closed with relevant scientific data sets.

ANCHOR closed without the last 10 planned patients in the bortezomib + melflufen study arm. Data sets will be large enough to draw relevant scientific conclusions.

ASCENT, and COAST have been closed with incomplete number of patients. It will not be possible to draw any relevant scientific conclusions from these data sets.

LIGHTHOUSE study was closed with incomplete number of patients. Topline data was presented in October 2022.

Effective July 8, 2021, FDA has requested a partial clinical hold of the clinical development program in the US.

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.

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.

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.

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.

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.

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.

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 with supporting dexamethasone in patients with relapsed and refractory multiple myeloma.

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