Best Response Number of Patients (%) Complete response 0 (0%) Partial response 1 (11%) Minor response
(SD) 1 (11%) Non-evaluable 2 (22%) Progressive disease 5 (55%) Overall response rate 2 (22%) Table 3.
In addition, there was one minor response
lasting 7 months, and 31 patients with disease stabilization.
Thirty patients (18%) achieved a minor response
, defined as a 50% or greater decrease in blood transfusion requirement.
Overall Response Rate (ORR), defined as the percentage of patients achieving a complete, partial or minor response
(CR, PR or MR), was the primary endpoint, with Time to Progression (TTP), Progression-Free Survival (PFS), Overall Survival (OS) and Safety as secondary endpoints.
Secondary endpoints include clinical benefit response (CR, PR or minor response
(MR)), duration of response, progression-free survival, time to progression, overall survival and safety.
In an intermittent oral dosing study, OSI-906 was well-tolerated up to doses of 450mg and has provided preliminary evidence of anti-tumor activity, with one confirmed partial response in an adrenocortical carcinoma (ACC) patient; one minor response
in a patient with non-small cell lung cancer (NSCLC); 14 patients with stabilization of their disease for longer than 12 weeks including 7 patients with stabilization of their disease for longer than 24 weeks (out of 27 patients evaluable for tumor response to date).
One patient with advanced solid tumors with brain metastases, who achieved a minor response
, showed significant improvement in memory, processing speed and executive function after six, 12 and 24 weeks of therapy.
Four (20%) patients achieved a complete response (CR), two (10%) a very good partial response, six (30%) a partial response (PR) and five (25%) a minor response
Among seventeen patients who have received prior treatment with bortezomib, three (18%) achieved partial responses, one patient achieved a minor response
, and ten patients achieved stable disease.