Tecentriq + Abraxane success in Phase III IMpassion 130 study to treat triple-negative breast cancer . Genentech/Roche
Genentech, announced positive results from the Phase III IMpassion130 study of Tecentriq (atezolizumab) plus chemotherapy (Abraxane [albumin-bound paclitaxel; nab-paclitaxel]) for the initial (first-line) treatment of unresectable locally advanced or metastatic triple-negative breast cancer (TNBC).
The Tecentriq and chemotherapy combination significantly reduced the risk of disease worsening or death (progression-free survival; PFS) compared with chemotherapy alone in all randomized patients (intention-to-treat [ITT]) (median PFS=7.2 vs. 5.5 months; hazard ratio [HR]=0.80, 95% CI: 0.69-0.92, p=0.0025) and the PD-L1-positive population (median PFS=7.5 vs. 5.0 months; HR=0.62, 95% CI: 0.49-0.78, p<0.0001), a subgroup determined by pd-l1 biomarker testing. at this interim analysis, statistical significance was not met for overall survival (os) in the itt population (median os="21.3" vs. 17.6 months; hr="0.84," 95% ci: 0.69-1.02, p="0.0840)," but showed a clinically meaningful 9.5-month os improvement in the pd-l1-positive population (median os="25.0" vs. 15.5 months; hr="0.62," 95% ci: 0.45-0.86). due to the hierarchical statistical design, results in the pd-l1-positive population were not formally tested.>
Follow-up will continue until the next planned analysis. Safety in the Tecentriq plus nab-paclitaxel arm appeared consistent with the known safety profiles of the individual medicines, and no new safety signals were identified with the combination. These data are being presented at the European Society for Medical Oncology (ESMO) 2018 Congress Presidential Symposium at 4:30 � 4:45 p.m. CEST (abstract LBA1_PR) and will also be featured in the official ESMO press program at 8:15 � 9:00 a.m. CEST. These results will simultaneously be published in the New England Journal of Medicine. Currently, Genentech has seven ongoing Phase III studies investigating Tecentriq in TNBC, including early and advanced stages of the disease.
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