Spanish-based biopharmaceutical company PharmaMar has commenced the multicentre, prospective, pivotal study to assess the efficacy of anti-cancer agent plitidepsin in patients with relapsed and refractory angioimmunoblastic T-cell lymphoma.
The one study arm is designed to evaluate the efficacy of plitidepsin in terms of overall response rate, which will be assessed by an independent committee following the Lugano classification response criteria.
The study will also focus on the secondary endpoint in determining the other effective aspects of plitidepsin, which are duration of response, progression free survival and overall survival, the pharmacokinetic characteristics, the safety profile of plitidepsina and the identification of possible biomarkers.
PharmaMar oncology unit clinical development director Dr Arturo Soto said: "This pivotal clinical trial will include 60 patients from approximately 25 investigative sites.
"After the recent announcement of the positive results obtained with plitidepsin in patients with multiple myeloma, we are continuing with the development of this molecule in other hematological tumours such as angioimmunoblastic T-cell lymphoma."
A marine origin, anti-tumoral compound, plitidepsin, acts as an anti-cancer agent that binds to the protein, eEF1A2, and targets its non-canonical role terminating the tumour cell through apoptosis (programmed death).
PharmaMar is exploring options to extend the usage of plitidepsin in treating hematological cancers, as it is undergoing Phase Ib trial in relapsed or refractory multiple mieloma as a triple combination of plitidepsin, bortezomib and dexamethasone, and a Phase II study in relapsed or refractory angioimmunoblastic T-cell lymphoma.
It has completed a Phase III trial in treating relapsed or refractory multiple myeloma.