IMblaze-370 (A ; all population), 2019 NCT02788279
atezolizumab alone (n=90) vs. regorafenib (n=90)
randomized controlled trial
atezolizumab monotherapy
atezolizumab monotherapy (1200 mg intravenously every 3 weeks. Atezolizumab dosemodification was not permitted.
regorafenib
regorafenib (160 mg orally once daily for days 1-21 of a 28-day cycle)
No crossover was allowed per protocol.
mCRC - 2nd line (L2)
Enrolment of patients with RAS wild-type tumours was capped at 50%
open label
73 academic medical centres and community oncology practices in 11 countries
P3/two sided no interim analysis . Two-sided type I error rate of 0ยท05 controlled by a hierarchical statistical testing procedure OS then PFS then ORR (testing atezolizumab monotherapy only if atezolizumab plus cobimetinib was positive).
IMblaze370 did not meet its primary endpoint of improved overall survival with atezolizumab plus cobimetinib or atezolizumab versus regorafenib.