An investigational antibody-drug conjugate being developed by GlaxoSmithKline for patients with multiple myeloma has been awarded Breakthrough Therapy Designation from the US Food and Drug Administration.
GSK2857916 has been designed as a monotherapy for use in patients who have failed at least three prior lines of therapy, including an anti-CD38 antibody, and who are refractory to a proteasome inhibitor and an immunomodulatory agent.
The breakthrough designation – designed to expedite the development and review medicines that target serious or life threatening conditions and have the potential to offer substantial benefit over existing therapies – rides on data from an ongoing Phase I open-label, dose escalation and expansion study in patients with relapsed/refractory multiple myeloma, irrespective of BCMA status.
“GSK plans to rapidly advance clinical trials with this promising therapy, alone and in combination with other therapies, to further investigate how GSK2857916 could benefit patients with multiple myeloma,” said Axel Hoos, SVP Oncology R&D, GSK.
“The monotherapy data that we have seen for GSK2857916 support its transformational potential and we look forward to working with regulators as we progress the development programme.”
Data from the study are to be presented in December in an oral presentation at the annual American Society of Hematology meeting in Atlanta, the firm noted.
The breakthrough designation also follows a PRIME designation awarded by European regulators last month, which offers enhanced support for the development of medicines that target an unmet medical need.