Roche has 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 (programmed death-ligand 1: expression ≥1%) 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% 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%) than with sunitinib alone (54%) 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 favouring 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% 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 are encouraged that initial treatment with TECENTRIQ and Avastin significantly reduced the risk of disease worsening or death in people with advanced kidney cancer, while also providing more time before disease symptoms interfere with day-to-day life compared with sunitinib, a current standard of care. 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, February 10 at 13:00-14:00 Pacific Time (PT), and were highlighted as part of the conference's official press programme.
About RCC Kidney cancer remains one of the most common cancers in the world, accounting for over 140,000 deaths worldwide each year,1 with renal cell carcinoma (RCC) accounting for approximately 90% of all cases.2 Over 300,000 people are diagnosed with RCC every year and currently only about 1 in 10 people are alive beyond 5 years following diagnosis of metastatic disease. RCC occurs when abnormal cells develop in the tissue of the kidneys, specifically in the small tubes (also known as tubules) where our blood is filtered.4 Typically, RCC is a single tumour in one kidney but, in rare cases, there can be multiple tumours, which can occur in one or both kidneys.Despite recent progress in the field of kidney cancer, treatment options for people with the disease remains limited.