Phase III IMmotion151 study showed Genentech’s Tecentriq (atezolizumab) and Avastin (bevacizumab) reduced the risk of disease worsening or death by 26 percent in certain people with advanced kidney cancer.
Genentech, a member of the Roche Group announced results from the positive Phase III IMmotion151 study of Tecentriq (atezolizumab) and Avastin (bevacizumab) as a first-line treatment for advanced or metastatic renal cell carcinoma (mRCC).
The study met its co-primary endpoint of investigator-assessed progression-free survival (PFS) in people whose disease expressed the PD-L1 (programed death-ligand 1: expression ≥ 1 percent) protein.
Those who received Tecentriq plus Avastin had a 26-percent reduced risk of disease worsening or death (PFS) compared to people treated with sunitinib (median PFS [mPFS]: 11.2 vs. 7.7 months; HR=0.74; 95 percent CI 0.57, 0.96; p=0.02).
Initial observations from the co-primary endpoint of overall survival (OS) in the overall study population (intention-to-treat, ITT) were encouraging, but are still immature. 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. The rate of treatment-related Grade 3-4 adverse events was lower with the Tecentriq and Avastin combination (40 percent) than with sunitinib alone (54 percent) in all treated patients.
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 in PFS favoring Tecentriq was seen across all patient risk factor groups (favorable, intermediate and poor) compared to sunitinib.
In addition, a pre-defined analysis of patient-reported outcomes (PRO) revealed that the combination of Tecentriq and Avastin markedly delayed the time to a worsening of disease symptoms that interfere with day-to-day life compared to sunitinib, (median time to deterioration: 11.3 vs. 4.3 months; HR=0.56; 95 percent CI: 0.46, 0.68) in the ITT population.
Due to the study design, pre-defined subgroup analyses and pre-defined PRO analyses were not assessed for statistical significance and are descriptive only.
“This is the second positive Phase III study that includes Tecentriq and Avastin as part of a treatment regimen, providing further evidence to support the potential of this unique combination,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “We look forward to discussing these results with regulatory authorities worldwide.”
The late-breaking IMmotion151 data will be presented at the 2018 Genitourinary Cancers Symposium on Saturday, Feb. 10 from 1:00-2:00 p.m. Pacific Time (PT) (Abstract #578), and were highlighted as part of the conference’s official press program.
Filed Under: Drug Discovery