Our pipeline and clinical studies
The purpose of our clinical development program is to support melflufen in the EU and lay the foundation for the next generation of drug candidates from the PDC platform.
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.
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
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.
Regulatory status
The regulatory status provides current information on the Company´s marketing authorizations and regulatory submissions.
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 alone in patients with relapsed and refractory multiple myeloma.