At the time of data analysis, the maximum tolerated dose had not yet been reached. Enrollment and dose escalation are ongoing.
Of the 16 adult patients treated across all dose levels, three (19 percent) achieved a complete remission or complete remission with incomplete platelet recovery, eight (50 percent) had resistant disease with clinical benefit or stable disease and five (31 percent) had progressive disease.
At dose levels greater than 1.0 milligram per kilogram (mg/kg), eight of 10 adult patients had clinical benefit, consisting of complete remission, complete remission with incomplete platelet recovery, resistant disease with clinical benefit or stable disease.
Of the four pediatric patients, one patient had resistant disease with clinical benefit, one had resistant disease without clinical benefit, one had progressive disease and one was unevaluable.
The most common adverse events of any grade occurring in adult patients were fever (56 percent), nausea (44 percent), chills (38 percent), fatigue (38 percent), blurred vision (38 percent) and vomiting (38 percent). Adverse events seen in at least two pediatric patients (50 percent or more) were vomiting (three patients) and abdominal pain, cough, shortness of breath, nausea and fever (two patients each).
“The phase 1 trial evaluating SGN-CD19A has demonstrated encouraging early antitumor activity and a generally well-tolerated safety profile among heavily pretreated patients with acute lymphoblastic leukemia and very aggressive types of lymphoma. In addition, multiple complete remissions have been observed in a parallel phase 1 study evaluating SGN-CD19A in aggressive non-Hodgkin lymphoma. Dose-escalation is ongoing in both phase 1 clinical trials, and we plan to report additional data during 2014,” said Jonathan Drachman, M.D., Chief Medical Officer and Executive Vice President, Research and Development at Seattle Genetics.
Although too early and too small of a sample to justify any conclusion, the fact that there are multiple complete remissions in this group of patient even while not yet knowing the proper dosing is a marvel on its own. Hopefully the day that big C isn't so big no more is finally within reach.
Now reporting multiple CR's! This is the most significant news of 2013, SGN-19a has already proved it's value. CD19 may prove to be a more valuable target than cd20 in B -cell. In think we're looking at the next Rituxan.
Just my opinion.
Silly question. Was this already known before today? I never got a chance to look at the ASH abstracts for SGEN so I don't know if this was already known and I am trying to figure out what impact if any today's news might have on trading on Monday. It sounds like very good, although early, results that will help show why we are not just Adcentris and we have a pipeline that could make SGEN stock price much higher in the months and years to come. GLTA hopefully today's PR was something new and we can get a nice pop on Monday.