Initial results from a Phase I study investigating the maximum tolerated dose, safety, pharmacokinetics and antitumor activity of LDK378 in 88 patients with ALK+ advanced malignancies, as detected by an FDA-approved test and who had progressed during treatment with, or were intolerant to, crizotinib, were presented at the European Society of Medical Oncology 2012 annual congress. The data showed marked responses in a majority of patients with ALK+ NSCLC. A response rate (including complete response [CR], partial response [PR] and unconfirmed PR) of 80% was observed in the patients who had experienced disease progression after crizotinib treatment.
Novartis has initiated two Phase II clinical trials to further evaluate the compound in this patient population with plans to initiate several Phase III clinical trials later this year. First regulatory filing is anticipated by early 2014.
"I think most of us know the next big catalyst is 113 in september.. I've been saying that so often I am beginning to get sick of repeating myself. Thats why I remain. Who cares if LDK378 received that breakthrougb designation. There is no way with all its adverse reaction s that it can be compared to 113. No way. Ok, pona "currently" is fully valued. Maybe for now. Not necessarily later as you well know. First line is coming so double pona's eventual value. That should add another 15 to arrive at 30. Then If/when 113 gets realized for best in class for ALK lets add 15 to make it 45. Is that worth staying in for and not being out during a period when tbe stock surges (I think that might have happened to some here). Yeah, I think its worth putting up with the tough times. Not to forget to mention what 113 will add to the price if it works for EGFR also..... that's where your 60 per share is coming from. If it goes much lower now, you might want to wade back in. It would be a shame to miss another surge"