Our Clinical Studies

Our clinical development program was created with the goal of providing a comprehensive set of data about melflufen (also referred to as melphalan flufenamide) in various patient groups. Melflufen is an investigational drug and has not been approved by the FDA or any other regulatory agency.

Our Clinical Studies

O-12-M1

O-12-M1 is a phase 1/2 study of melflufen and dexamethasone combination for patients with triple-class refractory multiple myeloma (O-12-M1)1,2

Final study results were presented at the 2017 American Society of Hematology (ASH) Annual Meeting. The full poster presentation can be found on the Presentations page.

To learn more about O-12-M1, please visit clinicaltrials.gov.

HORIZON

HORIZON is a pivotal phase 2 study of melflufen in combination with dexamethasone in patients with triple-class refractory multiple myeloma refractory to pomalidomide and/or an anti-CD38 monoclonal antibody (OP-106 HORIZON).3

The study was fully recruited in October 2019 and the final data cut was presented at the European Hematology Association meeting (EHA) on June 15th, 2020. The full poster presentation can be found on the Presentations page.

To learn more about HORIZON, please visit clinicaltrials.gov.

OCEAN

OCEAN is a pivotal phase 3 global, head-to-head study of melflufen and dexamethasone versus pomalidomide and dexamethasone in patients with triple-class refractory multiple myeloma refractory to lenalidomide (OP-103 OCEAN).4

This study completed enrollment in May 2020 and expects to present top line results from the study later this year.

To learn more about OCEAN, please visit clinicaltrials.gov.

ANCHOR

ANCHOR is a phase 1/2 study of melflufen and dexamethasone in combination with either bortezomib or daratumumab in patients with triple-class refractory multiple myeloma (OP-104 ANCHOR).5

To learn more about ANCHOR, please visit clinicaltrials.gov.

BRIDGE

BRIDGE is a phase 2 pharmacokinetic study of patients with triple-class refractory multiple myeloma and impaired renal function (OP-107 BRIDGE).6

To learn more about BRIDGE, please visit clinicaltrials.gov.

LIGHTHOUSE

LIGHTHOUSE is our next global phase 3 study of melflufen with subcutaneous daratumumab compared with daratumumab alone in patients with triple-class refractory multiple myeloma (OP-108 LIGHTHOUSE).7

This study is supported by Johnson & Johnson/Janssen Pharmaceuticals. The first patient in is expected in H2 2020. Similar to OCEAN, this study can also act as a confirmatory study for a potential accelerated FDA approval based on data from HORIZON.

 

Investigator-Initiated Trials

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