BICRBlinded Independent Central Review
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Opdivo and Yervoy demonstrated a disease control rate (DCR) of 54%, 43% and 49% per BICR using RECIST v1.1 across treatment arms A, B and C, respectively.
Moreover, entrectinib showed 83% (five out of six by BICR) confirmed intracranial ORR in patients with measurable brain metastases.
En 1931 se desvaloriza la moneda, caen las entradas de divisas por concepto de exportaciones y se decide cerrar la Caja de Conversion, para ser reabierta como Junta de Control de Cambio y Exportaciones, en 1932, esta vez adscrita al BICR.
Combining all the recurrences discussed above for either a 1 x 1 step or a 2 x 2 step and taking the strategy of reducing the number of matrix-vector multiplications by introducing an auxiliary vector recurrence and changing variables adopted for the BiCOR method [7] as well as for the BiCR method [31], together lead to the CSBiCOR method.
The major efficacy outcome measures were ORR and DoR according to RECIST v1.1, modified to follow a maximum of 10 target lesions and a maximum of five target lesions per organ, as assessed by BICR.
PFS as measured by Blinded Independent Central Review (BICR) evaluation, a pre-specified analysis supporting the primary endpoint, demonstrated a median PFS of 30.2 months vs 5.5 months for placebo.
In the recently announced interim data including patients from the STARTRK-2 trial in patients with ROS1 fusion-positive advanced NSCLC, entrectinib demonstrated a 78 percent (25 out of 32; by Investigator) and 69 percent (22 out of 32; by blinded independent central review, BICR) confirmed objective response rate (ORR).
Additionally, the primary endpoint of the OlympiAD trial was progression-free survival (PFS) as measured by a Blinded Independent Central Review (BICR), added the company.
The primary objective of this trial was objective response rate (ORR) as assessed by a blinded independent central review (BICR), for which results were previously presented; in the pooled intent-to-treat (ITT) population (n=401), the ORR was 11% with Opdivo alone and 22% with the combination.
The dual primary endpoints were OS and PFS, as assessed by blinded independent central review per RECIST (Response Evaluation Criteria in Solid Tumors) v1.1; key secondary endpoints included ORR, as assessed by BICR per RECIST 1.1, duration of response and safety.
In addition to meeting its primary endpoint of PFS assessed by blinded independent central review (BICR), the trial showed that patients treated with Lynparza had a 42% reduction in risk of their disease worsening or death (HR 0.58; 95% CI 0.43-0.80; p=0.0009; median 7.0 vs 4.2 months) compared to those who received chemotherapy (capecitabine, vinorelbine, eribulin).