Bristol-Myers Squibb has revealed that Empliciti (elotuzumab), when added to BMS/Celgene’s Revlimid (lenalidomide) and dexamethasone, has not proved successful in extending the time patients with newly-diagnosed myeloma who were ineligible for bone marrow transplant lived without their disease worsening.
The company revealed that the Phase III ELOQUENT-1 trial did not meet its primary endpoint of progression-free survival (PFS) versus Revlimid and dexamethasone alone, after patients received six monthly treatments with a combination of DE-122 and Lucentis or single-agent Lucentis.
“We are disappointed that the ELOQUENT-1 trial did not meet its primary endpoint in these previously untreated, transplant ineligible patients,” said BMS’ Noah Berkowitz, head of clinical development for the company’s haematology unit.
However, he added: “Empliciti, Revlimid and dexamethasone combination remains a standard treatment for patients with relapsed/refractory multiple myeloma, providing the potential for improved survival in this population of patients who are in need of additional treatment options.”
Last month Revlimid got the National Institute for Health and Care Excellence (NICE) go-ahead for patients with previously treated follicular lymphoma, bringing a new option to the market for around 900 patients.
The drug was recommended by the health body in combination with Roche’s MabThera (rituximab) for grade one to three variations of the disease.
Last year NICE also recommended Revlimid for previously untreated multiple myeloma in adults who are not eligible for a stem cell transplant and cannot take thalidomide.