In the 10-mg/kg arm, which is the dose used in the ongoing Phase III trials, median progression-free survival (PFS), or the time without disease progression, was 33 months after a median follow-up of 20.8 months and the objective response rate (ORR) was 92 percent...In one study, in relapsed/refractory MCL patients treated with ibrutinib monotherapy, there was an overall response rate (ORR) of 68 percent, including a complete response (CR) of 21 percent and a partial response (PR) of 47 percent
The complete response rate at week 12 was also statistically significant, and the drug met all secondary endpoints, as well, including patient-reported outcomes
Of the 15 patients, six achieved a clinical response (CR), including four patients with hematological improvement, and two patients with marrow CR or mCR, for an overall response rate of 40 percent
Data, which were updated at the Society of Nuclear Medicine and Molecular Imaging meeting in Vancouver, British Columbia, showed that, for the 61 patients who received the two consolidation 90Y-epratuzumab treatments, overall response rate was 91.8 percent (56 of 61 patients), with 50 patients (81.9 percent) achieving a complete or unconfirmed complete response
This regimen achieved a complete response rate of 19 percent and an overall response rate of 97 percent, with estimated progression-free survival at 24 months of 93 percent
The primary endpoint is overall survival, with secondary endpoints evaluating safety, tolerability, tumor response rates and the effect of therapy on Hsp27 levels and circulating tumor cells
The primary endpoints are safety and tolerability, with secondary endpoints including the pharmacokinetic profile of the drug and an efficacy evaluation as assessed by various parameters, such as response rate as measured by bone marrow biopsy
Array BioPharma Inc., of Boulder, Colo., reported clinical data at the International Myeloma Workshop in Kyoto, Japan, showing that ARRY-520, a selective KSP inhibitor, demonstrated single-agent activity in heavily pretreated patients with relapsed or refractory multiple myeloma, with 19 months median overall survival and a 16 percent overall response rate...Further data presented showed that patients with normal levels of alpha-1-acid glycoprotein (AAG) had a longer median overall survival (20.2
Study endpoints include progression-free survival, objective response rate, median overall survival and evaluation of pharmacodynamics tumor markers, in addition to safety
single-arm Phase II trial (REO 021) of intravenous Reolysin in combination with carboplatin and paclitaxel met the primary statistical endpoint of objective tumor response rate in squamous cell carcinoma of the lung (SCCLC
The recommendation followed a planned review of safety data from 200 patients in all four arms and sustained viral response rates four weeks (SVR4) after completion of therapy from 100 patients
The study also will assess secondary measures of clinical benefit, including progression-free survival, objective response rate and overall survival at six months and 12 months...The trial will measure on-treatment antiviral responses and sustained virologic response rates
The primary endpoint is rate of progression-free survival at 16 weeks, with secondary endpoints of objective response rate, duration of response and evaluation of pharmacodynamic tumor markers
The primary endpoint of the trial is progression-free survival, while secondary endpoints include response rate, overall survival and RAR beta expression, a potential biomarker for responders
An overall response rate of 53.6 percent was observed, with a median duration of response at eis interim analysis of 11.9 months