Rigel reported an abstract providing preliminary results of a Phase 2 clinical trial of its oral Syk inhibitor, R788 (fostamatinib disodium), in patients with relapsed or refractory B-cell non-Hodgkin's lymphomas (NHL). The abstract reports favorable responses for patients suffering from small lymphocytic lymphoma/chronic lymphocytic leukemia (SLL/CLL) or from diffuse large B-cell lymphoma (DLBCL), particularly in view of the advanced and refractory stage of the disease in the treated patients.
Furthermore, R788 appears to be well tolerated in this patient population. More studies of the drug candidate in these subsets of NHL are being planned. These results, with additional outcomes and follow-up, will be presented at the 10th International Conference on Malignant Lymphoma in Lugano, Switzerland later this week.
Drug Clinical Trials
Rigel will host a conference call today at 8:00 a.m. EDT to discuss these results (see conference call details below).
"The results of this study suggest that modulating the B-cell signaling pathway with R788 may represent a new therapeutic approach to non-Hodgkin's lymphoma particularly in DLBCL and SLL/CLL," said Elliott Grossbard, M.D., executive vice president and chief medical officer of Rigel. "As an oral agent that is believed to be well tolerated, R788 may become an attractive additional therapeutic option in these cancers."
At two months of therapy, 53 of the 59 patients were evaluated. Five patients (8% of enrolled) were withdrawn due to possibly related adverse events such as cytopenias and diarrhea, and one for non-compliance. Overall, as of January 15th, 44% of patients had been in the trial for over 7 months without progression of disease. The study is continuing and further results over longer periods of treatment will be available later in the year.