Our pipeline and 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.

Investigators and Patients should be aware that there is a partial clinical hold in place for Oncopeptides’ Clinical Trials, which means that we are not currently enrolling new patients. If patients are receiving a clinical benefit from melphalan flufenamide they may continue treatment provided they are informed of the risks and sign a revised written informed consent.

Oncopeptides PDC platform

HCPSs and patient should note that on July 28, the US Food and Drug Administration issued a safety alert regarding an increased risk of death associated with Pepaxto® (melphalan flufenamide), in the OCEAN study. To read this alert you may visit the FDA website here.

Patient safety is paramount to Oncopeptides. We are fully cooperating with the FDA as they continue to evaluate the OCEAN data. We will provide additional updates as they become available.

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.

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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. 

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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