Bristol-Myers Squibb and AbbVie have unveiled new data from a mid-stage trial of their experimental monoclonal antibody elotuzumab, raising hopes that the drug could offer a signifiant benefit in progression-free survival (PFS) in patients with the blood cancer multiple myeloma.
In patients taking elotuzumab 10 mg/kg in combination with lenalidomide and low-dose dexamethasone, median PFS was found to be 33 months after a follow-up of 20.8 months, while the objective response rate (ORR) was 92%.
Previously reported data showed that those taking the higher 20 mg/kg dose of the drug experienced less of a benefit, with PFS of 18 months after a follow-up of 17.1 months and an ORR of 76%, and so the 10 mg/kg dose was selected for Phase III testing.
The data, presented over the weekend at the Annual Congress of the European Haematology Association in Sweden, also threw up no concerns over safety, with findings consistent with those reported earlier on in the trial.
The most common Grade 3/4 adverse events observed in the 10 mg/kg dose were lymphopenia (26%), neutropenia (21%), thrombocytopenia (21%), anaemia (13%), leukopenia (8%), hyperglycaemia (5%), pneumonia (8%), diarrhoea (10%), fatigue (8%), and hypokalemia (8%), the firms noted.
Thierry Facon, Hospital Claude Huriez, Service des Maladies du Sang, Lille, France, said Phase II data on elotuzumab "are encouraging and support further evaluation in Phase III trials.”