Genentech says Phase III IMmotion151 Study rhowed reduced risk of worsening
Genentech, a member of the Roche Group, announced that the Phase III IMmotion151 study met its co-primary endpoint of investigator-assessed progression-free survival, or PFS, and demonstrated that the combination of TECENTRIQ and Avastin provided a statistically significant and clinically meaningful reduction in the risk of disease worsening or death, or PFS, in people whose disease expressed the PD-L1 protein compared with sunitinib for the first-line treatment of people who have advanced or metastatic renal cell carcinoma, or mRCC. Observations of a pre-specified subgroup analysis of the TECENTRIQ and Avastin combination indicated that, in people whose disease expressed PD-L1, a numerical difference favoring TECENTRIQ was seen across all patient risk factor groups compared to sunitinib; however, due to the study design these data could not be assessed for statistical significance and are descriptive only. Assessment of secondary endpoints is ongoing. Safety for the TECENTRIQ and Avastin combination appeared consistent with the known safety profile of the individual medicines and what was previously reported in the Phase II IMmotion150 study. No new safety signals were identified with the combination. Results will be presented at an upcoming oncology conference in 2018. Top-line results from the co-primary endpoint of overall survival, or OS, are not mature.