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BICRBlinded Independent Central Review
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Response to A+CHP by CD30 Expression in the ECHELON-2 Trial: As previously reported, the ECHELON-2 trial met its primary endpoint with the combination of ADCETRIS plus CHP resulting in a statistically significant improvement in PFS versus the control arm of CHOP per Blinded Independent Central Review. In addition, overall survival in the ADCETRIS plus CHP arm was statistically significant compared to CHOP.
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.
Within the ROS1+ NSCLC blinded independent central review, or BICR, efficacy evaluable population, the median number of prior TKI therapies was one, the majority of which were crizotinib.
The major efficacy outcome measures were objective response rate and duration of response 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 blinded independent central review.
The trial met both primary endpoints of confirmed objective response rate, as assessed by Blinded Independent Central Review, and overall survival.
A total of 30 patients treated across the first 5 dose escalation cohorts with ROS1+ NSCLC were in the efficacy evaluable population, of which 27 were evaluable by Blinded Independent Central Review
Results showed a 44 percent objective response rate, or ORR, per blinded independent central review. The duration of response was consistent with that recently reported in the previous phase 1 study, or EV-101.
The primary objective of this trial was objective response rate (ORR) as assessed by a blinded independent central review, for which results were previously presented; in the pooled intent-to-treat population (ITT) (n=401), the ORR was 11% with Opdivo alone and 22% with the combination.