Tuesday, GlaxoSmithKline plc (GSK) announced that its cancer drug Bexxar for treating non-Hodgkin's lymphoma in heavily pre-treated, Rituximab-refractory patients, experienced an overall survival of 6.7 years in its Phase-II trial. In another Phase-II study, it was found that among 76 patients with previously untreated follicular lymphoma, the 10-year overall survival rate with Bexxar was 83% and the 10-year progression-free survival rate was 38%.
In addition to the 10-year overall survival rate of 83%, results showed that the overall confirmed response rate was 95%; with 75% of patients in the trial achieving a complete response. The median duration of a complete response was 9.1 years and the median amount of time follicular lymphoma was responsive to Bexxar therapy was 6 years.
For non-Hodgkin's lymphoma Rituximab-refractory patients, the median overall survival with Bexxar was 6.7 years and the overall confirmed response rate was 65% and the complete response rate was 38%. The amount of time patients maintained a response to therapy was 18.9 months (median), with an estimated 40% of patients maintaining a response at five years. There were only two known relapses after two years. Additionally, patients experienced a median of 10.4 months without disease progression, with 28% of patients remaining progression-free at approximately five years.
Rival drug Rituximab is co-marketed in the U.S. by Biogen Idec Inc. (BIIB) and Genentech, Inc.
In the other study, the long-term safety and efficacy data of Bexxar was evaulated in patients with slow-growing, follicular large-cell or transformed B-cell lymphoma, which was progressive after Rituximab. To date, 20 deaths have been reported and 10 without documented disease progression. Six second cancers have occurred; with two patients reporting leukemia, one prostate cancer, two skin cancers and one primary hepatic. The incidence of secondary leukemia remains the same as previously reported in 2005 at 5% i.e. 2 of 40 patients.
GSK is currently trading at $42.15, down $0.49 or 1.14% on the NYSE.
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