September 2012, Vol 1, No 4
Progressive Myeloma Responds to Monoclonal AntibodyConference News
More than 80% of patients with relapsed or refractory multiple myeloma responded to a monoclonal antibody against a cell surface protein expressed by almost all myeloma cells, results of a phase 2 clinical trial showed.
All patients received lenalidomide and dexamethasone and were randomized to 10 or 20 mg of
The overall response rate included 92% of patients treated with 10 mg of elotuzumab and 73% of those who received 20 mg. After a median follow-up of 17.2 months, the median progression-free survival (PFS) had not been reached among patients in the 10-mg cohort, whereas patients assigned to 20 mg of elotuzumab had a median PFS of 18 months.
“These data are really encouraging when compared to those achieved with lenalidomide and high-dose dexamethasone,” Philippe Moreau, MD, a hematologic oncologist at Hotel-Dieu University Hospital in Nantes, France, said at the Annual Meeting of the American Society of Clinical Oncology.
An analysis limited to patients who had received only 1 prior regimen showed that all patients treated with the 10-mg dose of elotuzumab had objective responses, as did 82% of those who received the higher dose of the monoclonal antibody.
“[These results] indicate that this combination could also be effective in frontline treatment,” Moreau added.
Elotuzumab is a humanized monoclonal antibody that targets the CS1 glycoprotein expressed by more than 95% of myeloma cells. Normal cells express little or no CS1.
Moreau presented results of a trial involving 73 patients with previously treated multiple myeloma. A majority of the patients had received 2 or more prior regimens, and more than 60% of the patients had received lenalidomide and bortezomib.
The results showed that 33 of 36 patients in the 10-mg group had objective responses, including 5 complete responses. In the 20-mg arm, 30 of 37 patients responded to elotuzumab. Moreau reported that 48% of the entire study population had responses that met criteria for very good partial responses.
The most common grade 3/4 adverse events were neutropenia, lymphopenia, and thrombocytopenia, each of which occurred in 16% of patients.
Molecularly targeted therapies change the vascular milieu and can cause hypertension, fluid retention, and thromboembolic phenomena. However, the absolute risk of cardiotoxicity is much lower with targeted therapies compared with anthracyclines, stated Michael S. Ewer, MD, from the MD Anderson Cancer Center in Houston, Texas, at the recent meeting of [ Read More ]
Adaptive Clinical Trial Design: From Simple Dose-Finding Trials to Large-Scale Personalized Medicine Trials
While there’s great excitement about the potential of personalized medicine to improve care – particularly in oncology – there’s also a healthy dose of pessimism regarding the cost of clinical trials needed to bring optimal, targeted therapies to market. While many researchers believe that personalized medicine is the future of [ Read More ]