Article
Author(s):
Immunotherapy combination outperforms chemotherapy in patients with advanced or metastatic renal cell carcinoma.
Genentech recently announced positive results from the phase 3 IMmotion151 clinical trial of atezolizumab (Tecentriq) and bevacizumab (Avastin) as a first-line treatment for advanced or metastatic renal cell carcinoma (mRCC), according to a company press release.
Included in the trial were 915 patients with mRCC who were randomized 1:1 to receive the immunotherapy combination or sunitinib chemotherapy.
The study met its co-primary endpoint of progression-free survival (PFS) among patients with PD-L1-expressing mRCC.
Patients treated with atezolizumab plus bevacizumab had a 26% lower risk of disease worsening or death compared with patients treated with sunitinib, according to the release.
Genentech reported that although the evaluation of overall survival—another primary endpoint—were encouraging, the results were premature.
The trial did not raise any new safety concerns and the safety profile appeared consistent with previous findings, according to the release.
Notably, the rate of treatment-related serious adverse events was 14% lower among patients treated with atezolizumab and bevacizumab compared with those treated with sunitinib monotherapy.
The results of a subgroup analysis of the immunotherapy combination showed that patients whose disease expressed PD-L1 had improved PFS across all risk factor groups compared with sunitinib, according to the release.
Additionally, a pre-defined analysis of patient-reported outcomes demonstrated that atezolizumab plus bevacizumab significantly delayed the time to symptom worsening that interfered with day-to-day life compared with sunitinib.
Genentech noted that these sub-analyses were descriptive only and were not evaluated for statistical significance.
“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, MD, 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 interfered with day-to-day life compared with sunitinib, a current standard of care. We look forward to discussing these results with regulatory authorities worldwide.”
This combination is being explored across many cancer types, including RCC. Genentech said that bevacizumab may enhance the anti-cancer immunity abilities of atezolizumab by inhibiting VEGF immunosuppression, promoting T cell tumor infiltration, and activating T cell response, according to the release.
FDA Grants Orphan Drug Designation to MDL-101 for Congenital Muscular Dystrophy Type 1a